Acne VulgarisPhase 4C0000-411NCT01016977

A Phase 4, Single-Blind, Randomized, Study to Compare the Tolerability and Efficacy of 0.1% Tazorac Cream When Used in Combination With Either Duac Gel or Acanya Gel for the Treatment of Facial Acne Vulgaris

A Phase 4 study testing Clindamycin 1%/Benzoyl Peroxide 5% and 0.1% tazarotene and clindamycin phosphate 1.2%/benzoyl peroxide 2.5% and 0.1% tazarotene in people with Acne Vulgaris, run by Stiefel, a GSK Company.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A single-blind (investigator-blinded), randomized, parallel group, single center study to evaluate the tolerability and efficacy of combination therapy with Duac Gel / 0.1% Tazorac Cream and Acanya Gel / 0.1% Tazorac Cream for the treatment of facial acne vulgaris. Read more about this study

Who is it for?: Ages 12 to 45 years
Conditions the study is for: Acne Vulgaris
What is being tested?: Clindamycin 1%/Benzoyl Peroxide 5% and 0.1% tazarotene and clindamycin phosphate 1.2%/benzoyl peroxide 2.5% and 0.1% tazarotene
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: No sites listed yet
Study dates: Oct 2009to Apr 2010
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 45 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Documented diagnosis of acne vulgaris.
Lesion count: 20 to 50 inflammatory (papules and pustules) and 30 to 100 noninflammatory (open and closed - comedones) facial lesions excluding nose, and ≤ 1 small nodular lesion. Cystic lesions are not allowed at baseline.
Investigator Static Global Assessment of 3 or 4 at Baseline.

Who cannot join

Clinically relevant finding at baseline or medical history of severe systemic diseases or diseases of the facial skin, other than acne vulgaris.
Subjects with cystic acne lesions.
Facial hair that may obscure the accurate assessment of acne grade.
History or presence of regional enteritis or inflammatory bowel disease (eg, ulcerative colitis, pseudomembranous colitis, chronic diarrhea, celiac disease or a history of antibiotic-associated colitis) or similar symptoms.
Concurrent use of medications known to be photosensitizers (eg, thiazides, tetracyclines, fluoroquinolones, phenothiazines, and sulfonamides) because of the possibility of increased phototoxicity.
Concomitant use of neuromuscular blocking agents. Clindamycin has neuromuscular blocking activities, which may enhance the action of other neuromuscular blocking agents.

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Use of topical anti-acne medications (eg, benzoyl peroxide, retinoids, azelaic acid, resorcinol, salicylates, sulfacetamide sodium and derivatives, and glycolic acid) within the past 2 weeks.
Use of topical antibiotics on the face within the past 2 weeks or systemic antibiotics within the past 4 weeks.
Use of topical corticosteroids on the face or systemic corticosteroids within the past 2 to 4 weeks, respectively. Use of inhaled, intra-articular or intra lesional (other than for facial acne lesions) steroids is acceptable.
Use of systemic retinoids, such as Isotretinoin, within the past 6 months.
Concomitant use of the following types of facial products: astringents, toners, abradants, hair removal wax, facials, peels containing glycolic or other acids, masks, washes or soaps containing benzoyl peroxide, sulfacetamide sodium or salicylic acid, non-mild facial cleansers, or moisturizers that contain retinol, salicylic acid, or α- or β hydroxy acids.
Concomitant use of medications that are reported to exacerbate acne, (eg, vitamins such as vitamin D, vitamin A, vitamins B2, B6, B12; haloperidol, halogens such as iodide and bromide, lithium, cyclosporine, psoralen, sirolimus, imatinib, aripiprazole, isoniazid, valproate acid, hydantoin, and phenobarbital) as these may impact efficacy assessments. Iron supplements and folate are acceptable.
Facial procedures (eg, chemical peel, lasers/lights, photodynamic therapy, microdermabrasion, artificial ultraviolet therapy) performed by an esthetician, beautician, physician, nurse, or other practitioner, within the past 4 weeks.
Known hypersensitivity or previous allergic reaction to any component(s) or excipient(s) of the study products.
Use of any investigational medications or treatments within the past 4 weeks.
Treatment with estrogens, including oral, implanted and topical contraceptives, androgens, or anti-androgenic agents for 12 weeks or less immediately prior to starting study product and have not been prescribed for the treatment of Acne Vulgaris. Subjects that have been treated with estrogens, as described above, androgens, or anti androgenic agents for more than 12 consecutive weeks prior to start of study treatment are allowed to enroll as long as they do not expect to change dose, medication, or discontinue use during the study.
Evidence of recent alcohol or drug abuse (in the opinion of the investigator).
Live in the same household as currently enrolled subjects.
Employee of the investigator, a clinical research organization, or Stiefel Laboratories who is involved in the study or an immediate family member (eg, partner, offspring, parents, siblings or sibling's offspring) of an employee involved in the study.

About this study

Official title: A Phase 4, Single-Blind, Randomized, Study to Compare the Tolerability and Efficacy of Tazorac Cream When Used in Combination With Either Duac Gel or Acanya Gel for the Treatment of Facial Acne Vulgaris

Read the detailed description

This is a single-blind (investigator-blinded), randomized, parallel group, single center study to evaluate the tolerability and efficacy of combination therapy with Duac Gel/Tazorac Cream and Acanya Gel/Tazorac Cream for the treatment of facial acne vulgaris. Approximately 40 male and female subjects will be enrolled (20 per study group).

Subjects will participate in the study for 12 weeks; visits will be scheduled at baseline and at weeks 1, 2, 4, 8, and 12 (total of 6 visits). Eligible subjects will be randomized at baseline to 1 of the 2 study groups in a 1:1 ratio (Duac Gel/Tazorac Cream to Acanya Gel/Tazorac Cream). Subjects will apply either Duac Gel or Acanya Gel to the face each morning and apply Tazorac Cream to the face each evening.

Tolerability will be evaluated through subject assessments of burning/stinging, itching, and oiliness and through investigator assessments of peeling, erythema, and dryness. In addition, subjects will evaluate their overall skin comfort and record the usage of moisturizer and sunscreen, if needed. Efficacy will be assessed through lesion counts (total, inflammatory and noninflammatory) and ISGA. Safety will be assessed by evaluating adverse events (AEs), concomitant medication use, and withdrawals from the study.

This is an investigator-blinded study; therefore, subjects and study-center staff will not be blinded to study treatment allocation. Subjects (and parents or legal guardians) and study-center staff will be instructed not to reveal study product allocation to the investigator.

Conditions: Acne Vulgaris
Being tested: Clindamycin 1%/Benzoyl Peroxide 5% and 0.1% tazarotene, clindamycin phosphate 1.2%/benzoyl peroxide 2.5% and 0.1% tazarotene
Medical subject headings: Acne Vulgaris

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Clindamycin 1%/Benzoyl Peroxide 5% and 0.1% tazaroteneDrug
Clindamycin 1%/Benzoyl Peroxide 5% and 0.1% tazarotene
clindamycin phosphate 1.2%/benzoyl peroxide 2.5% and 0.1% tazaroteneDrug
clindamycin phosphate 1.2%/benzoyl peroxide 2.5% and 0.1% tazarotene

Study groups in NCT01016977
Study group	Role	What they receive
Duac & taz	Active comparator	Clindamycin 1%/Benzoyl Peroxide 5% and 0.1% tazarotene Receives: Drug: Clindamycin 1%/Benzoyl Peroxide 5% and 0.1% tazarotene
Acanya & taz	Active comparator	clindamycin phosphate 1.2%/benzoyl peroxide 2.5% and 0.1% tazarotene Receives: Drug: clindamycin phosphate 1.2%/benzoyl peroxide 2.5% and 0.1% tazarotene

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Change From Baseline in Erythema at Weeks 1, 2, 4, 8, and 12
Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Erythema (redness of the skin, due to increased blood flow in the capillaries in the lower layers of theh skin) was assessed by the investigator based on a 6-point scale: 0=none, which is normal; 1=trace, which is mild and localized; 2=mild, which is mild and diffuse; 3=moderate, which is moderate and diffuse; 4=marked, which is moderate and dense; 5=severe, which is prominent and dense.
Measured: Baseline and Weeks 1, 2, 4, 8, and 12
Mean Change From Baseline in Dryness at Weeks 1, 2, 4, 8, and 12
Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Dryness was assessed by the investigator based on a 6-point scale: 0=none, which is normal; 1=trace, which is mild and localized; 2=mild, which is mild and diffuse; 3=moderate, which is moderate and diffuse; 4=marked, which is moderate and dense; 5=severe, which is prominent and dense.
Measured: Baseline and Weeks 1, 2, 4, 8, and 12
Mean Change From Baseline in Peeling at Weeks 1, 2, 4, 8, and 12
Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Peeling was assessed by the investigator based on a 6-point scale: 0=none, which is normal; 1=trace, which is mild and localized; 2=mild, which is mild and diffuse; 3=moderate, which is moderate and diffuse; 4=marked, which is moderate and dense; 5=severe, which is prominent and dense.
Measured: Baseline and Weeks 1, 2, 4, 8, and 12
Mean Change From Baseline in Burning/Stinging at Weeks 1, 2, 4, 8, and 12
Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Burning/stinging was assessed by participants based on a 6-point scale: 0=none: normal, no discomfort; 1=trace: awareness, no discomfort, no intervention required; 2=mild: noticeable discomfort, intermittent awareness; 3=moderate: noticeable discomfort, continuous awareness; 4=marked: definite discomfort, continuous awareness, interferes occasionally with normal daily activities; 5=severe: definite continuous discomfort, interferes with normal daily activities.
Measured: Baseline and Weeks 1, 2, 4, 8, and 12
Mean Change From Baseline in Itching at Weeks 1, 2, 4, 8, and 12
Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 6, 8, and 12 minus the value at baseline. Itching was assessed by participants based on a 6-point scale: 0=none: normal, no discomfort; 1=trace: awareness, no discomfort, no intervention required; 2=mild: noticeable discomfort, intermittent awareness; 3=moderate: noticeable discomfort, continuous awareness; 4=marked: definite discomfort, continuous awareness, interferes occasionally with normal daily activities; 5=severe: definite continuous discomfort, interferes with normal daily activities.
Measured: Baseline and Weeks 1, 2, 4, 8, and 12
Mean Change From Baseline in Oiliness at Weeks 1, 2, 4, 8, and 12
Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Oiliness was assessed by participants based on a 6-point scale: 0=none: normal, no discomfort; 1=trace: awareness, no discomfort, no intervention required; 2=mild: noticeable discomfort, intermittent awareness; 3=moderate: noticeable discomfort, continuous awareness; 4=marked: definite discomfort, continuous awareness, interferes occasionally with normal daily activities; 5=severe: definite continuous discomfort, interferes with normal daily activities.
Measured: Baseline and Weeks 1, 2, 4, 8, and 12
Mean Change From Baseline in Skin Overall Comfort at Weeks 1, 2, 4, 8, and 12
Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Skin comfort was assessed by participants based on 5-point scale: +2, very comfortable; +1, comfortable; 0, neutral; -1, somewhat uncomfortable; or -2, uncomfortable.
Measured: Baseline and Weeks 1, 2, 4, 8, and 12

Secondary outcomes (8)

Number of Participants With at Least a Two-grade Improvement in ISGA Score From Baseline to Week 12
The investigator conducted the overall assessment of the participant's facial acne vulgaris based on the Investigator's Static Global Assessment Scale (ISGA). The ISGA is a 6-point scale: 0, clear skin with no acne vulgaris; 1, almost clear skin; 2, mild; 3, moderate; 4, severe; 5, very severe.
Measured: Baseline and Week 12
Mean Change From Baseline in Inflammatory and Non-inflammatory Lesion Counts at Weeks 1, 2, 4, 8, and 12
Inflammation is defined as a localized protective reaction of tissue to irritation, injury, or infection, characterized by pain, redness, swelling, and sometimes loss of function. The investigator counted inflammatory (papules, pustules, and nodules) and non-inflammatory (open and closed comedones) lesions on a participant's face at each study visit. The face is defined as the hairline edge to the mandibular line and should include the forehead, cheeks, and chin. W, Week.
Measured: Baseline and Weeks 1, 2, 4, 8, and 12
Mean Change From Baseline in Total Lesion Count at Weeks 1, 2, 4, 8, and 12
The investigator will count inflammatory (papules, pustules, and nodules) and non-inflammatory (open and closed comedones) lesions on the participant's face at each study visit. The face is defined as the hairline edge to the mandibular line and should include the forehead, cheeks, and chin.
Measured: Baseline and Weeks 1, 2, 4, 8, and 12
Mean Change From Baseline for the Global Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12
Skindex-29 is a 3-component (symptomatic, emotional, and functional) self-administered questionnaire (comprised of 30 questions) used to comprehensively measure the complex effects of skin diseases on a participant's quality of life. Participants were asked to answer questions based on a 5-point scale concerning their feelings over the past 4 weeks about the skin condition that has bothered them the most: 1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time. The Global Score is the sum of the 30 question scores; total score ranges from 30 to 150.
Measured: Baseline and Week 12
Mean Change From Baseline for the Symptomatic Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12
Skindex-29 is a 3-component (symptomatic, emotional, and functional) self-administered questionnaire (comprised of 30 questions) used to comprehensively measure the complex effects of skin diseases on a participant's quality of life. Participants were asked to answer questions based on a 5-point scale concerning their feelings over the past 4 weeks about the skin condition that has bothered them the most: 1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time. The Symptomatic Score is the sum of 7 question scores; total score ranges from 7 to 35.
Measured: Baseline and Week 12
Mean Change From Baseline for the Emotional Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12
Skindex-29 is a 3-component (symptomatic, emotional, and functional) self-administered questionnaire (comprised of 30 questions) used to comprehensively measure the complex effects of skin diseases on a participant's quality of life. Participants were asked to answer questions based on a 5-point scale concerning their feelings over the past 4 weeks about the skin condition that has bothered them the most: 1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time. The Emotional Score is the sum of 10 question scores; total score ranges from 10 to 50.
Measured: Baseline and Week 12
Mean Change From Baseline for the Functional Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12
Skindex-29 is a 3-component (symptomatic, emotional, and functional) self-administered questionnaire (comprised of 30 questions) used to comprehensively measure the complex effects of skin diseases on a participant's quality of life. Participants were asked to answer questions based on a 5-point scale concerning their feelings over the past 4 weeks about the skin condition that has bothered them the most: 1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time. The Functional Score is the sum of 12 question scores; total score ranges from 12 to 60.
Measured: Baseline and Week 12
Overall Satisfaction With Study Product at Week 12
Overall satisfaction with the study product was assessed from a participant's answer to the following question on the product acceptability and preference questionnaire at the end of study (i.e., Week 12): "What is your overall satisfaction with the study product." Participants assessed overall satisfaction with the study product in the morning and evening, based on a 6-point scale: 1, very satisfied; 2, satisfied; 3, neutral (no opinion); 4, unsatisfied; 5, very unsatisfied.
Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2009Apr 2010

First posted20 Nov 2009 (estimated)
Study startOct 2009
Primary completionApr 2010
Study completionApr 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Acne VulgarisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01016977
Sponsor's protocol ID: 114566
Acronym: C0000-411
Status last verified: Dec 2016
First submitted: 19 Nov 2009
Last updated: 30 Jan 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

Dhawan SS, Gwazdauskas J. Clindamycin phosphate 1.2%-benzoyl peroxide (5% or 2.5%) plus tazarotene cream 0.1% for the treatment of acne. Cutis. 2013 Feb;91(2):99-104.
PubMed 23513559

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 3
Study of New Antiandrogenic Progestogen + Low-dose Estrogen for Moderate Acne Vulgaris
Acne Vulgaris, Acne Vulgaris on the Face
Not yet recruiting
A Single-Center, Open-Label Study to Assess the Efficacy and Tolerability of a Brightening Serum in Skin of Color Patients With Post Inflammatory Hyperpigmentation
Post-inflammatory Hyperpigmentation, Post-acne Hyperpigmentation
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
Recruiting
Comparison of Topical Clascoterone 1% Cream Versus Adapalene 0.1% Cream in the Treatment of Mild-to-Moderate Acne Vulgaris
Acne Vulgaris
RecruitingPhase 1
Phase 1 Study to Evaluate the Safety, Tolerability, PK, and PD of TVB-3567 in Healthy Participants With or Without Acne
Acne

All Acne Vulgaris trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 4, Single-Blind, Randomized, Study to Compare the Tolerability and Efficacy of Tazorac Cream When Used in Combination With Either Duac Gel or Acanya Gel for the Treatment of Facial Acne Vulgaris
ClinicalTrials.gov ID: NCT01016977
Acronym / sponsor ID: C0000-411 / 114566
Conditions: Acne Vulgaris
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Stiefel, a GSK CompanyIndustry (pharma, biotech, devices)
Collaborators: GlaxoSmithKline
Study start: Oct 2009
Primary completion: Apr 2010 (actual)
Study completion: Apr 2010 (actual)
First posted: 20 Nov 2009 (estimated)
Results: Posted 23 Feb 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Duac & taz	Active comparator	Drug: Clindamycin 1%/Benzoyl Peroxide 5% and 0.1% tazaroteneClindamycin 1%/Benzoyl Peroxide 5% and 0.1% tazarotene
Acanya & taz	Active comparator	Drug: clindamycin phosphate 1.2%/benzoyl peroxide 2.5% and 0.1% tazaroteneclindamycin phosphate 1.2%/benzoyl peroxide 2.5% and 0.1% tazarotene

Who may qualify

Ages: 12 to 45 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (3 listed)

Documented diagnosis of acne vulgaris.
Lesion count: 20 to 50 inflammatory (papules and pustules) and 30 to 100 noninflammatory (open and closed - comedones) facial lesions excluding nose, and ≤ 1 small nodular lesion. Cystic lesions are not allowed at baseline.
Investigator Static Global Assessment of 3 or 4 at Baseline.

Key exclusion criteria (19 listed)

Clinically relevant finding at baseline or medical history of severe systemic diseases or diseases of the facial skin, other than acne vulgaris.
Subjects with cystic acne lesions.
Facial hair that may obscure the accurate assessment of acne grade.
History or presence of regional enteritis or inflammatory bowel disease (eg, ulcerative colitis, pseudomembranous colitis, chronic diarrhea, celiac disease or a history of antibiotic-associated colitis) or similar symptoms.
Concurrent use of medications known to be photosensitizers (eg, thiazides, tetracyclines, fluoroquinolones, phenothiazines, and sulfonamides) because of the possibility of increased phototoxicity.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Clindamycin 1%/Benzoyl Peroxide 5% and 0.1% tazaroteneClindamycin 1%/Benzoyl Peroxide 5% and 0.1% tazarotene	Drug	Duac & taz
clindamycin phosphate 1.2%/benzoyl peroxide 2.5% and 0.1% tazaroteneclindamycin phosphate 1.2%/benzoyl peroxide 2.5% and 0.1% tazarotene	Drug	Acanya & taz

Primary outcome

Mean Change From Baseline in Erythema at Weeks 1, 2, 4, 8, and 12
Time frame: Baseline and Weeks 1, 2, 4, 8, and 12
Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Erythema (redness of the skin, due to increased blood flow in the capillaries in the lower layers of theh skin) was assessed by the investigator based on a 6-point scale: 0=none, which is normal; 1=trace, which is mild and localized; 2=mild, which is mild and diffuse; 3=moderate, which is moderate and diffuse; 4=marked, which is moderate and dense; 5=severe, which is prominent and dense.
Mean Change From Baseline in Dryness at Weeks 1, 2, 4, 8, and 12
Time frame: Baseline and Weeks 1, 2, 4, 8, and 12
Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Dryness was assessed by the investigator based on a 6-point scale: 0=none, which is normal; 1=trace, which is mild and localized; 2=mild, which is mild and diffuse; 3=moderate, which is moderate and diffuse; 4=marked, which is moderate and dense; 5=severe, which is prominent and dense.
Mean Change From Baseline in Peeling at Weeks 1, 2, 4, 8, and 12
Time frame: Baseline and Weeks 1, 2, 4, 8, and 12
Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Peeling was assessed by the investigator based on a 6-point scale: 0=none, which is normal; 1=trace, which is mild and localized; 2=mild, which is mild and diffuse; 3=moderate, which is moderate and diffuse; 4=marked, which is moderate and dense; 5=severe, which is prominent and dense.
Mean Change From Baseline in Burning/Stinging at Weeks 1, 2, 4, 8, and 12
Time frame: Baseline and Weeks 1, 2, 4, 8, and 12
Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Burning/stinging was assessed by participants based on a 6-point scale: 0=none: normal, no discomfort; 1=trace: awareness, no discomfort, no intervention required; 2=mild: noticeable discomfort, intermittent awareness; 3=moderate: noticeable discomfort, continuous awareness; 4=marked: definite discomfort, continuous awareness, interferes occasionally with normal daily activities; 5=severe: definite continuous discomfort, interferes with normal daily activities.
Mean Change From Baseline in Itching at Weeks 1, 2, 4, 8, and 12
Time frame: Baseline and Weeks 1, 2, 4, 8, and 12
Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 6, 8, and 12 minus the value at baseline. Itching was assessed by participants based on a 6-point scale: 0=none: normal, no discomfort; 1=trace: awareness, no discomfort, no intervention required; 2=mild: noticeable discomfort, intermittent awareness; 3=moderate: noticeable discomfort, continuous awareness; 4=marked: definite discomfort, continuous awareness, interferes occasionally with normal daily activities; 5=severe: definite continuous discomfort, interferes with normal daily activities.
Mean Change From Baseline in Oiliness at Weeks 1, 2, 4, 8, and 12
Time frame: Baseline and Weeks 1, 2, 4, 8, and 12
Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Oiliness was assessed by participants based on a 6-point scale: 0=none: normal, no discomfort; 1=trace: awareness, no discomfort, no intervention required; 2=mild: noticeable discomfort, intermittent awareness; 3=moderate: noticeable discomfort, continuous awareness; 4=marked: definite discomfort, continuous awareness, interferes occasionally with normal daily activities; 5=severe: definite continuous discomfort, interferes with normal daily activities.
Mean Change From Baseline in Skin Overall Comfort at Weeks 1, 2, 4, 8, and 12
Time frame: Baseline and Weeks 1, 2, 4, 8, and 12
Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Skin comfort was assessed by participants based on 5-point scale: +2, very comfortable; +1, comfortable; 0, neutral; -1, somewhat uncomfortable; or -2, uncomfortable.

8 secondary outcomes

Number of Participants With at Least a Two-grade Improvement in ISGA Score From Baseline to Week 12
Time frame: Baseline and Week 12
Mean Change From Baseline in Inflammatory and Non-inflammatory Lesion Counts at Weeks 1, 2, 4, 8, and 12
Time frame: Baseline and Weeks 1, 2, 4, 8, and 12
Mean Change From Baseline in Total Lesion Count at Weeks 1, 2, 4, 8, and 12
Time frame: Baseline and Weeks 1, 2, 4, 8, and 12
Mean Change From Baseline for the Global Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12
Time frame: Baseline and Week 12
Mean Change From Baseline for the Symptomatic Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12
Time frame: Baseline and Week 12
Mean Change From Baseline for the Emotional Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12
Time frame: Baseline and Week 12
Mean Change From Baseline for the Functional Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12
Time frame: Baseline and Week 12
Overall Satisfaction With Study Product at Week 12
Time frame: Week 12

Results and safety

Results posted to the registry on 23 Feb 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tazorac Cream/Duac Gel	20	17
Tazorac Cream/Acanya Gel	20	18

Primary outcome: Mean Change From Baseline in Erythema at Weeks 1, 2, 4, 8, and 12

Time frame: Baseline and Weeks 1, 2, 4, 8, and 12. Mean (Standard Deviation). Unit: units on a scale

Measure	Tazorac Cream/Duac Gel n = 20	Tazorac Cream/Acanya Gel n = 20
Week 1, n=19, 17	0.79 (1.03)	0.76 (0.75)
Week 2, n=20, 19	0.60 (0.82)	0.47 (0.70)
Week 4, n=20, 20	0.50 (0.89)	0.55 (0.76)
Week 8, n=20, 20	0.20 (0.62)	0.20 (0.52)
Week 12, n=20, 20	0.25 (0.64)	0.10 (0.79)

Tazorac Cream/Duac Gel vs Tazorac Cream/Acanya Gel: p = 0.9597, ANCOVA
Tazorac Cream/Duac Gel vs Tazorac Cream/Acanya Gel: p = 0.5538, ANCOVA
Tazorac Cream/Duac Gel vs Tazorac Cream/Acanya Gel: p = 0.6315, ANCOVA

Population analysed: Intent-to-Treat (ITT) Population: all randomized participants who received study product. Some participants did not return for all visits; thus, data were not captured for all participants in the ITT Population at all visits.

Primary outcome: Mean Change From Baseline in Dryness at Weeks 1, 2, 4, 8, and 12

Time frame: Baseline and Weeks 1, 2, 4, 8, and 12. Mean (Standard Deviation). Unit: units on a scale

Measure	Tazorac Cream/Duac Gel n = 20	Tazorac Cream/Acanya Gel n = 20
Week 1, n=19, 17	1.11 (1.05)	1.18 (0.81)
Week 2, n=20, 19	1.15 (0.81)	0.84 (0.96)
Week 4, n=20, 20	0.65 (0.75)	0.55 (0.83)
Week 8, n=20, 20	0.50 (0.95)	0.15 (0.59)
Week 12, n=20, 20	0.20 (0.70)	-0.05 (0.51)

Tazorac Cream/Duac Gel vs Tazorac Cream/Acanya Gel: p = 0.5961, ANCOVA
Tazorac Cream/Duac Gel vs Tazorac Cream/Acanya Gel: p = 0.2293, ANCOVA
Tazorac Cream/Duac Gel vs Tazorac Cream/Acanya Gel: p = 0.9852, ANCOVA

Population analysed: ITT Population. Some participants did not return for all visits; thus, data were not captured for all participants in the ITT Population at all visits.

Primary outcome: Mean Change From Baseline in Peeling at Weeks 1, 2, 4, 8, and 12

Time frame: Baseline and Weeks 1, 2, 4, 8, and 12. Mean (Standard Deviation). Unit: units on a scale

Measure	Tazorac Cream/Duac Gel n = 20	Tazorac Cream/Acanya Gel n = 20
Week 1, n=19, 17	1.11 (1.05)	1.06 (0.83)
Week 2, n=20, 19	1.05 (0.83)	0.79 (0.98)
Week 4, n=20, 20	0.60 (0.75)	0.55 (0.83)
Week 8, n=20, 20	0.50 (0.95)	0.10 (0.55)
Week 12, n=20, 20	0.20 (0.70)	-0.05 (0.51)

Tazorac Cream/Duac Gel vs Tazorac Cream/Acanya Gel: p = 0.8545, ANCOVA
Tazorac Cream/Duac Gel vs Tazorac Cream/Acanya Gel: p = 0.2895, ANCOVA
Tazorac Cream/Duac Gel vs Tazorac Cream/Acanya Gel: p = 0.8234, ANCOVA

Population analysed: ITT Population. Some participants did not return for all visits; thus, data were not captured for all participants in the ITT Population at all visits.

Primary outcome: Mean Change From Baseline in Burning/Stinging at Weeks 1, 2, 4, 8, and 12

Time frame: Baseline and Weeks 1, 2, 4, 8, and 12. Mean (Standard Deviation). Unit: units on a scale

Measure	Tazorac Cream/Duac Gel n = 20	Tazorac Cream/Acanya Gel n = 20
Week 1, n=19, 17	1.58 (1.87)	1.65 (1.69)
Week 2, n=20, 19	0.70 (1.59)	0.84 (1.07)
Week 4, n=20, 20	1.25 (1.92)	0.55 (0.76)
Week 8, n=20, 20	0.60 (1.27)	0.45 (0.69)
Week 12, n=20, 20	0.50 (1.40)	0.40 (0.82)

Tazorac Cream/Duac Gel vs Tazorac Cream/Acanya Gel: p = 0.7546, ANCOVA
Tazorac Cream/Duac Gel vs Tazorac Cream/Acanya Gel: p = 0.7705, ANCOVA
Tazorac Cream/Duac Gel vs Tazorac Cream/Acanya Gel: p = 0.0259, ANCOVA

Population analysed: ITT Population. Some participants did not return for all visits; thus, data were not captured for all participants in the ITT Population at all visits.

8 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tazorac Cream/Duac Gel	0 of 20 (0%)	11 of 20 (55%)	Not reported
Tazorac Cream/Acanya Gel	0 of 20 (0%)	7 of 20 (35%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23513559Dhawan SS, Gwazdauskas J. Clindamycin phosphate 1.2%-benzoyl peroxide (5% or 2.5%) plus tazarotene cream 0.1% for the treatment of acne. Cutis. 2013 Feb;91(2):99-104.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Feb 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change From Baseline in Erythema at Weeks 1, 2, 4, 8, and 12 (time frame: Baseline and Weeks 1, 2, 4, 8, and 12). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01016977, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2017.