Acne VulgarisPhase 4NCT00757523
Evaluation of the Effectiveness, Safety, and Tolerability of Duac Akne Gel and Epiduo Gel in the Treatment of Facial Acne Vulgaris
A Phase 4 study testing Epiduo Gel and Duac Gel in people with Acne Vulgaris, run by Stiefel, a GSK Company at 17 sites in Germany.
Trial summary
The purpose of this study is to compare the effectiveness of two marketed products in subjects with 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?
- Epiduo Gel and Duac Gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 382 participants
- Where
- 17 sitesGermany
- Study dates
- 10 Sep 2008to 24 Jun 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Males or females 12 to 45 years of age, inclusive, in good general health.
- Clinical diagnosis of acne vulgaris
- Capable of understanding and willing to provide signed and dated written voluntary informed consent
- Female subjects of childbearing potential must have a negative pregnancy test at baseline. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception
- Subjects who have been treated with estrogens, androgens, or anti-androgenic agents for more than 12 consecutive weeks prior to the first dose of study product are allowed to enroll as long as they do not expect to change dose, drug, or discontinue use during the study.
- The ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.
Who cannot join
- Female subjects who are pregnant, trying to become pregnant, or who are lactating.
- Any clinically relevant finding at their baseline physical examination or medical history such as severe systemic diseases or diseases of the facial skin other than acne vulgaris.
- 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, or a history of antibiotic-associated colitis) or similar symptoms.
- Used topical antibiotics on the face or systemic antibiotics within the past 2 and 4 weeks, respectively.
- Used topical corticosteroids on the face or systemic corticosteroids within the past 4 weeks. Use of inhaled, intra articular or intra-lesional (other than for facial acne lesions) steroids is acceptable.
Show all 17Show fewer
- Used systemic retinoids within the past 6 months.
- Using drugs known to be photosensitizers (eg, thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of increased phototoxicity.
- Using neuromuscular blocking agents. Clindamycin has neuromuscular blocking activities, which may enhance the action of other neuromuscular blocking agents.
- Used topical anti-acne medications (eg, BPO, retinoids, azelaic acid, resorcinol, salicylates, sulfacetamide sodium and derivatives, glycolic acid) within the past 2 weeks.
- Used any investigational therapy within 4 weeks of study day 1.
- Using the following types of facial products: astringents, toners, abradants, facials, peels containing glycolic or other acids, masks, washes or soaps containing BPO, sulfacetamide sodium or salicylic acid, non-mild facial cleansers, or moisturizers that contain retinol, salicylic acid, or α- or β-hydroxy acids.
- Using medications that are reported to exacerbate acne (eg, mega-doses of certain vitamins such as vitamin D, vitamin A, and vitamins B2, B6, and B12; haloperidol; halogens such as iodide and bromide; lithium; hydantoin; and phenobarbital) as these may impact efficacy assessments.
- Have had a facial procedure (chemical or laser peel, microdermabrasion, artificial ultraviolet [UV] therapy) performed by an esthetician, beautician, physician, nurse, or other practitioner, within the past 4 weeks.
- Have a known hypersensitivity or previous allergic reaction to any of the active components, lincomycin, adapalene, clindamycin, BPO, or excipients of the study medication.
- Employees of a clinical research organization involved in the study, or Stiefel Laboratories, or an immediate family member (partner, offspring, parents, siblings, or sibling's offspring) of an employee.
- Have a member of the same household in this trial.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Germany17 sites
GSK Investigational Site
Berlin, 14052
GSK Investigational Site
Berlin, 14169
GSK Investigational Site
Bonn, 53105
GSK Investigational Site
Dessau, 06847
GSK Investigational Site
Dülmen, 48249
GSK Investigational Site
Essen, 45122
GSK Investigational Site
Frankfurt, 60590
GSK Investigational Site
Giessen, 35392
GSK Investigational Site
Halle, 06097
GSK Investigational Site
Hamburg, 20246
GSK Investigational Site
Kiel, 24148
GSK Investigational Site
Landau, 76829
GSK Investigational Site
Magdeburg, 39120
GSK Investigational Site
München, 80337
GSK Investigational Site
München, 80802
GSK Investigational Site
Münster, 48149
GSK Investigational Site
Potsdam, 14469
About this study
Official title: A Multi-center, Randomized, Evaluator-blind, Parallel-group Evaluation of the Efficacy, Safety, and Tolerability of Duac Akne Gel and Epiduo Gel in the Topical Treatment of Facial Acne Vulgaris
The purpose of this study is to compare the effectiveness of two marketed products in subjects with facial acne vulgaris
Read the detailed description
Multiple physiopathological factors have been associated with acne vulgaris. Drug combinations are frequently used to address these factors and to improve efficacy in the treatment of acne. The current study proposes to compare a fixed-dose (once-daily) combination gel product containing benzoyl peroxide (BPO)and clindamycin against a fixed-dose (once-daily) combination gel product containing BPO and adapalene for the treatment of facial acne vulgaris.
- Conditions
- Acne Vulgaris
- Being tested
- Epiduo Gel, Duac Gel
- Keywords
- Acne Vulgaris, Akne, Acne, Akne Vulgaris
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epiduo GelDrug
Epiduo Gel (combination of 0.1% adapalene and 2.5% benzoyl peroxide (BPO) in a gel preparation). Treatments administered once-daily in the evening for 12 weeks
Duac GelDrug
Also called Duac Akne Gel
Duac Akne Gel (combination of 1% clindamycin phosphate and 5% benzoyl peroxide (BPO) in a gel preparation). Treatments administered once-daily in the evening for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Epiduo Gel | Active comparator | Epiduo Gel (combination of 0.1% adapalene and 2.5% benzoyl peroxide (BPO) in a gel preparation). Receives: Drug: Epiduo Gel |
| Duac Gel | Experimental | Duac Akne Gel (combination of 1% clindamycin phosphate and 5% benzoyl peroxide (BPO) in a gel preparation). Receives: Drug: Duac Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in inflammatory lesion count from Baseline to Week 12
The efficacy assessor performed a count of inflammatory lesions (papules and pustules, including nasal lesions) each study visit. Lesion counts were confined to the face. Baseline was defined as the value at Day 1 (Visit 1). Change from Baseline was calculated by subtracting the Baseline from the post-randomization value at Week 12.
Measured: Baseline (Day 1) and Week 12
Secondary outcomes (18)
Percentage of participants who achieved treatment success, defined as improvement of 2 grades or more in their Investigator Static Global Assessment (ISGA) acne severity scale from Baseline to Week 12
ISGA success was defined as the improvement of 2 grades or more in the participant's acne severity scale at Week 12. The area considered for assessment must be confined to the face. Acne severity of the participant's face was assessed by the assessor using the ISGA scale, ranging from 0 to 5 where 0=Clear skin with no inflammatory or non-inflammatory lesions. ;1=almost clear: Rare non-inflammatory lesions with no more than one small inflammatory lesion ;2=mild: Some non-inflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions). ;3=moderate: Up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion; 4=severe: Up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions and 5= Very Severe: Many non-inflammatory and inflammatory lesions and more than a few nodular lesions. May have cystic lesions. The higher score indicated more severe lesions.
Measured: Week 12
Time to 2-grade improvement in ISGA from Baseline
ISGA success was defined as the improvement of 2 grades or more in the participant's acne severity scale at Week 12. Time to ISGA success from Baseline was analyzed using Kaplan-Meier Estimate of time. Baseline was defined as the value at Day 1 (Visit 1). Participants with missing week 12 evaluations were considered failures.
Measured: Week 12
Percent change in total lesion count from Baseline to week 12
The efficacy assessor performed a count of total lesions at each study visit. Lesion counts were confined to the face. Baseline was defined as the value at Day 1 (Visit 1). Change from Baseline was calculated by subtracting the Baseline from the post-randomization value at Week 12.
Measured: Baseline (Day 1) and Week 12
Absolute change in inflammatory lesion count from Baseline to Weeks 1, 2, 4, 8
The efficacy assessor performed a count of inflammatory lesions (papules and pustules, including nasal lesions) each study visit. Lesion counts were confined to the face. Baseline was defined as the value at Day 1 (Visit 1). Change from Baseline was calculated by subtracting the Baseline from the post-randomization value at Weeks 1, 2, 4, 8.
Measured: Baseline (Day 1) and Weeks 1, 2, 4, 8
Absolute change in inflammatory lesion count from Baseline to Week 12.
The efficacy assessor performed a count of inflammatory lesions (papules and pustules, including nasal lesions) each study visit. Lesion counts were confined to the face. Baseline was defined as the value at Day 1 (Visit 1). Change from Baseline was calculated by subtracting the Baseline from the post-randomization value at Week 12.
Measured: Baseline (Day 1) and Week 12
Absolute change in total lesion count from Baseline to Weeks 1, 2, 4, 8
The efficacy assessor performed a count of total lesions at each study visit. Lesion counts were confined to the face. Baseline was defined as the value at Day 1 (Visit 1). Change from Baseline was calculated by subtracting the Baseline from the post-randomization value at Weeks 1, 2, 4, 8.
Measured: Baseline (Day 1) and Weeks 1, 2, 4, 8
Absolute change in total lesion count from Baseline to Week 12
The efficacy assessor performed a count of total lesions at each study visit. Lesion counts were confined to the face. Baseline was defined as the value at Day 1 (Visit 1). Change from Baseline was calculated by subtracting the Baseline from the post-randomization value at Week 12.
Measured: Baseline (Day 1) and Week 12
Percentage of participants who achieved treatment success from Baseline to Weeks 1, 2, 4, and 8
ISGA success was defined as the improvement of 2 grades or more in the participant's acne severity scale at Week 12. Acne severity of the participant's face was assessed by the assessor using the ISGA scale, ranging from 0 to 5 where 0= Clear skin with no inflammatory or non-inflammatory lesions and 5= Very Severe: Many non-inflammatory and inflammatory lesions and more than a few nodular lesions. May have cystic lesions. The higher score indicated more severe lesions. The area considered for the ISGA was confined to the face. Data for percentage of participants who achieved treatment success from Baseline to Weeks 1, 2, 4, and 8 was not collected.
Measured: Weeks 1, 2, 4, and 8
Absolute change in non-inflammatory lesion count from Baseline to Weeks 1 2, 4,8
The efficacy assessor performed a count of non-inflammatory lesions (open and closed comedones, excluding nasal lesions) each study visit. Lesion counts were confined to the face. Baseline was defined as the value at Day 1 (Visit 1). Change from Baseline was calculated by subtracting the Baseline from the post-randomization value at Weeks 1, 2, 4, 8.
Measured: Baseline (Day 1) and Weeks 1,2,4,8
Absolute change in non-inflammatory lesion count from Baseline to Week 12
The efficacy assessor performed a count of non-inflammatory lesions (open and closed comedones, excluding nasal lesions) each study visit. Lesion counts were confined to the face. Baseline was defined as the value at Day 1 (Visit 1). Change from Baseline was calculated by subtracting the Baseline from the post-randomization value at Week 12.
Measured: Baseline (Day 1) and Week 12
Percent change in non-inflammatory lesion count from Baseline to Weeks 1, 2, 4, 8
The efficacy assessor performed a count of non-inflammatory lesions (open and closed comedones, excluding nasal lesions) each study visit. Lesion counts were confined to the face. Baseline was defined as the value at Day 1 (Visit 1). Change from Baseline was calculated by subtracting the Baseline from the post-randomization value at Weeks 1, 2, 4, 8.
Measured: Baseline (Day 1) and Weeks 1, 2, 4, 8
Percent change in non-inflammatory lesion count from Baseline to Week 12
The efficacy assessor performed a count of non-inflammatory lesions (open and closed comedones, excluding nasal lesions) each study visit. Lesion counts were confined to the face. Baseline was defined as the value at Day 1 (Visit 1). Change from Baseline was calculated by subtracting the Baseline from the post-randomization value at Week 12.
Measured: Baseline (Day 1) and Week 12
Percent change in inflammatory lesion count from Baseline to Weeks 1, 2, 4, and 8
The efficacy assessor performed a count of inflammatory lesions (papules and pustules, including nasal lesions) each study visit. Lesion counts were confined to the face. Baseline was defined as the value at Day 1 (Visit 1). Change from Baseline was calculated by subtracting the Baseline from the post-randomization value at Weeks 1, 2, 4, and 8.
Measured: Baseline (Day 1) and Weeks 1, 2, 4, and 8
Percent change in total lesion count from Baseline to Weeks 1, 2, 4, and 8
The efficacy assessor performed a count of total lesions at each study visit. Lesion counts were confined to the face. Baseline was defined as the value at Day 1 (Visit 1). Change from Baseline was calculated by subtracting the Baseline from the post-randomization value at Weeks 1, 2, 4, and 8.
Measured: Baseline (Day 1) and Weeks 1, 2, 4, and 8
Time to reach 50 percent reduction in inflammatory lesion counts from Baseline
Time to reach 50 percent reduction in inflammatory lesion counts (papules and pustules, including nasal lesions) from Baseline was analyzed using Kaplan-Meier Estimate of time. Baseline was defined as the value at Day 1 (Visit 1).
Measured: Week 12
Time to reach 50 percent reduction in non-inflammatory lesion counts from Baseline
Time to reach 50 percent reduction in non-inflammatory lesion counts ((open and closed comedones, excluding nasal lesions) from Baseline was analyzed using Kaplan-Meier Estimate of time. Baseline was defined as the value at Day 1 (Visit 1).
Measured: Week 12
Time to reach 50 percent reduction in total lesion counts from Baseline
Time to time to reach 50 percent reduction in total lesion counts from Baseline was analyzed using Kaplan-Meier Estimate of time. Baseline was defined as the value at Day 1 (Visit 1).
Measured: Week 12
Percentage of participants who had a Subject's Global Change Assessment score (SGAC) of 0 or 1 at Weeks 1, 2, 4, 8, and 12
SGCA is measured on a scale (Clear, Almost Clear, Mild, Moderate, Severe, Very Severe) with Clear being best and Very Severe being worst. The area considered for the ISGA was confined to the face. Data for percentage of participants who had a SGAC of 0 or 1 at Weeks 1, 2, 4, 8, and 12 was not collected.
Measured: Upto Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2008 (estimated)
- Study start10 Sep 2008
- Primary completion24 Apr 2009
- Study completion24 Jun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Outcomes assessor
- Enrolment
- 382 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stiefel, a GSK Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00757523
- Sponsor's protocol ID
- S194-401
- Status last verified
- Aug 2017
- First submitted
- 21 Sep 2008
- Last updated
- 17 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Zouboulis CC, Fischer TC, Wohlrab J, Barnard J, Alio AB. Study of the efficacy, tolerability, and safety of 2 fixed-dose combination gels in the management of acne vulgaris. Cutis. 2009 Oct;84(4):223-9.
PubMed 19911678
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Evaluator-blind, Parallel-group Evaluation of the Efficacy, Safety, and Tolerability of Duac Akne Gel and Epiduo Gel in the Topical Treatment of Facial Acne Vulgaris
- ClinicalTrials.gov ID
- NCT00757523
- Acronym / sponsor ID
- S194-401
- Conditions
- Acne Vulgaris
- Keywords
- Acne Vulgaris, Akne, Acne, Akne Vulgaris
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 382 participants (actual)
- Lead sponsor
- Stiefel, a GSK CompanyIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- 10 Sep 2008 (actual)
- Primary completion
- 24 Apr 2009 (actual)
- Study completion
- 24 Jun 2009 (actual)
- First posted
- 23 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the effectiveness of two marketed products in subjects with facial acne vulgaris
Detailed description
Multiple physiopathological factors have been associated with acne vulgaris. Drug combinations are frequently used to address these factors and to improve efficacy in the treatment of acne. The current study proposes to compare a fixed-dose (once-daily) combination gel product containing benzoyl peroxide (BPO)and clindamycin against a fixed-dose (once-daily) combination gel product containing BPO and adapalene for the treatment of facial acne vulgaris.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epiduo Gel | Active comparator | Drug: Epiduo GelEpiduo Gel (combination of 0.1% adapalene and 2.5% benzoyl peroxide (BPO) in a gel preparation). |
| Duac Gel | Experimental | Drug: Duac GelDuac Akne Gel (combination of 1% clindamycin phosphate and 5% benzoyl peroxide (BPO) in a gel preparation). |
Who may qualify
- Ages
- 12 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Males or females 12 to 45 years of age, inclusive, in good general health.
- Clinical diagnosis of acne vulgaris
- Capable of understanding and willing to provide signed and dated written voluntary informed consent
- Female subjects of childbearing potential must have a negative pregnancy test at baseline. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception
- Subjects who have been treated with estrogens, androgens, or anti-androgenic agents for more than 12 consecutive weeks prior to the first dose of study product are allowed to enroll as long as they do not expect to change dose, drug, or discontinue use during the study.
Key exclusion criteria (17 listed)
- Female subjects who are pregnant, trying to become pregnant, or who are lactating.
- Any clinically relevant finding at their baseline physical examination or medical history such as severe systemic diseases or diseases of the facial skin other than acne vulgaris.
- 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, or a history of antibiotic-associated colitis) or similar symptoms.
- Used topical antibiotics on the face or systemic antibiotics within the past 2 and 4 weeks, respectively.
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 |
|---|---|---|
| Epiduo GelEpiduo Gel (combination of 0.1% adapalene and 2.5% benzoyl peroxide (BPO) in a gel preparation). Treatments administered once-daily in the evening for 12 weeks | Drug | Epiduo Gel |
| Duac GelAlso: Duac Akne GelDuac Akne Gel (combination of 1% clindamycin phosphate and 5% benzoyl peroxide (BPO) in a gel preparation). Treatments administered once-daily in the evening for 12 weeks | Drug | Duac Gel |
Primary outcome
Percent change in inflammatory lesion count from Baseline to Week 12
Time frame: Baseline (Day 1) and Week 12
The efficacy assessor performed a count of inflammatory lesions (papules and pustules, including nasal lesions) each study visit. Lesion counts were confined to the face. Baseline was defined as the value at Day 1 (Visit 1). Change from Baseline was calculated by subtracting the Baseline from the post-randomization value at Week 12.
18 secondary outcomes
Percentage of participants who achieved treatment success, defined as improvement of 2 grades or more in their Investigator Static Global Assessment (ISGA) acne severity scale from Baseline to Week 12
Time frame: Week 12
Time to 2-grade improvement in ISGA from Baseline
Time frame: Week 12
Percent change in total lesion count from Baseline to week 12
Time frame: Baseline (Day 1) and Week 12
Absolute change in inflammatory lesion count from Baseline to Weeks 1, 2, 4, 8
Time frame: Baseline (Day 1) and Weeks 1, 2, 4, 8
Absolute change in inflammatory lesion count from Baseline to Week 12.
Time frame: Baseline (Day 1) and Week 12
Absolute change in total lesion count from Baseline to Weeks 1, 2, 4, 8
Time frame: Baseline (Day 1) and Weeks 1, 2, 4, 8
Absolute change in total lesion count from Baseline to Week 12
Time frame: Baseline (Day 1) and Week 12
Percentage of participants who achieved treatment success from Baseline to Weeks 1, 2, 4, and 8
Time frame: Weeks 1, 2, 4, and 8
Absolute change in non-inflammatory lesion count from Baseline to Weeks 1 2, 4,8
Time frame: Baseline (Day 1) and Weeks 1,2,4,8
Absolute change in non-inflammatory lesion count from Baseline to Week 12
Time frame: Baseline (Day 1) and Week 12
Percent change in non-inflammatory lesion count from Baseline to Weeks 1, 2, 4, 8
Time frame: Baseline (Day 1) and Weeks 1, 2, 4, 8
Percent change in non-inflammatory lesion count from Baseline to Week 12
Time frame: Baseline (Day 1) and Week 12
Percent change in inflammatory lesion count from Baseline to Weeks 1, 2, 4, and 8
Time frame: Baseline (Day 1) and Weeks 1, 2, 4, and 8
Percent change in total lesion count from Baseline to Weeks 1, 2, 4, and 8
Time frame: Baseline (Day 1) and Weeks 1, 2, 4, and 8
Time to reach 50 percent reduction in inflammatory lesion counts from Baseline
Time frame: Week 12
Time to reach 50 percent reduction in non-inflammatory lesion counts from Baseline
Time frame: Week 12
Time to reach 50 percent reduction in total lesion counts from Baseline
Time frame: Week 12
Percentage of participants who had a Subject's Global Change Assessment score (SGAC) of 0 or 1 at Weeks 1, 2, 4, 8, and 12
Time frame: Upto Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2017.
- Results publication: PubMed 19911678Zouboulis CC, Fischer TC, Wohlrab J, Barnard J, Alio AB. Study of the efficacy, tolerability, and safety of 2 fixed-dose combination gels in the management of acne vulgaris. Cutis. 2009 Oct;84(4):223-9.
Related trials for Acne Vulgaris
Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
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
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Epiduo Gel and Duac Gel in people with Acne Vulgaris, run by Stiefel, a GSK Company at 17 sites in Germany.
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 6 inclusion and 17 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 17 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percent change in inflammatory lesion count from Baseline to Week 12 (time frame: Baseline (Day 1) and Week 12). 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 NCT00757523, 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 17 Aug 2017.