Acne VulgarisPhase 4NCT01015638
Compare the Tolerance of Clindamycin 1% /Benzoyl Peroxide (BPO) 5% Gel to Clindamycin 1.2%/ BPO 2.5% Topical Medications
A Phase 4 study testing Clindamycin and BPO 5% gel and Clindamycin phosphate and benzoyl peroxide 2.5% gel. in people with Acne Vulgaris, run by Stiefel, a GSK Company at 1 site in United States.
Trial summary
This is a single-blind (blinded expert grader) study that will enroll 25-30 healthy volunteers without facial acne. On 1 side of the face, the subject will apply 1 of the 2 test products, clindamycin and benzoyl peroxide 5% or clindamycin phosphate and benzoyl peroxide 2.5% and the other side of the face will remain… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Clindamycin and BPO 5% gel and Clindamycin phosphate and benzoyl peroxide 2.5% gel.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Sep 2009
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol specific procedures are performed.
- Male and female subjects aged from 18 to 45 years at time of consent.
- Is willing to discontinue use of all facial products (other than the cleanser provided and makeup or razor and facial shave product) on the face for the 3 days before their baseline/day 0 visit and use only the provided facial products and their normal makeup or razor and facial shaving product for the duration of the study.
- Is willing to not change brands of makeup or razor and facial shave product during the study.
- Is willing to refrain from using any facial product on the face other than study products and their normal makeup or razor and facial shave product for the duration of the study.
- Able to complete the study and to comply with study instructions.
- Sexually active females of childbearing potential participating in the study must agree to use a medically acceptable method of contraception while receiving protocol-assigned product
Who cannot join
- Female subjects who are pregnant, trying to become pregnant, or breast feeding.
- Male subjects that have facial beards (mustache and/or goatee is acceptable).
- Is a Type I diabetic.
- Has active or chronic skin allergies.
- Has a history of acute or chronic disease that might interfere with, or increase the risk of study participation.
- Has participated in other facial studies in the preceding 30 days or other clinical studies in preceding 14 days.
Show all 22Show fewer
- Had skin cancer treatment in preceding 12 months.
- Has damaged skin on facial areas (eg, from sunburn, tattoos, scars).
- Had any medical procedure (eg, laser resurfacing, chemical peels, plastic surgery) to facial areas in preceding 12 months.
- Had any cosmetic procedure (eg, microdermabrasion, etc.) to facial areas within 8 weeks of the baseline visit.
- Use of topical retinoids or related agents for the treatment of acne or photoaging in the preceding 6 months.
- Any dermatological disorder, which in the investigator's opinion, may interfere with the accurate evaluation of the subject's facial appearance.
- Has known sensitivities or allergies to cosmetics, soaps, fragrances, or any of the ingredients in the test products.
- Is currently going through menopause and experiencing hot flashes.
- Received any investigational drug within 30 days of study day 0 or who are scheduled to receive an investigational drug other than the study product during the study.
- Currently using any medication, which in the opinion of the investigator may affect the evaluation of the study product or place the subject at undue risk (including but not limited to asthma medications, oral steroids, rifampin, anticonvulsants, St. John's wart).
- Currently taking any topical or oral erythromycin-containing products.
- History of regional enteritis, ulcerative colitis, or antibiotic-associated colitis.
- Currently suffering from any disease or condition, which in the opinion of the investigator may affect the evaluation of the study product or place the subject at undue risk.
- Live in the same household as currently enrolled subjects.
- Employees of investigator/ clinical research organization (CRO) or Stiefel, a GSK Company involved in the study, or an immediate family member (partner, offspring, parents, siblings or sibling's offspring) of an employee involved in the study.
- Any other condition or factor the investigator or his duly assigned representative believes may affect the skin response or the interpretation of the test results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Two-week Study to Determine and Compare the Tolerance and Irritation Potential of Duac® Topical Gel (Clindamycin 1% and Benzoyl Peroxide 5%) to ACANYA™ Gel (Clindamycin Phosphate 1.2% and Benzoyl Peroxide 2.5%) Topical Acne Medications
This is a single-blind (blinded expert grader) study that will enroll 25-30 healthy volunteers without facial acne. On 1 side of the face, the subject will apply 1 of the 2 test products, clindamycin and benzoyl peroxide 5% or clindamycin phosphate and benzoyl peroxide 2.5% and the other side of the face will remain non-treated to serve as a control.
Read the detailed description
This is a single-blind (blinded expert grader), parallel group, randomized, half-face study being conducted at one clinical site. On 1 side of the face, the subject will apply 1 of the 2 test products, clindamycin and benzoyl peroxide 5%) or clindamycin and benzoyl peroxide 2.5%) and the other side of the face will remain non-treated to serve as a control. Approximately 25-30 male and female healthy subjects without facial acne, aged 18 to 45, will be randomly assigned to each product.
The eligible subjects (screened 3 days prior to randomization) who qualify will be entered into a 2-week treatment phase. The once-daily applications for the clindamycin and benzoyl peroxide 5%and clindamycin phosphate and benzoyl peroxide 2.5%) will be supervised at the site, Monday through Friday of each week. Subjects will apply the study product at home on Saturdays and Sundays and record the times of application on a diary card.
A blinded expert grader will rate comparative product tolerance in terms of erythema and dryness on each week day (excluding Saturdays and Sundays) during the study before study product is applied.
Instruments will be used to measure transepidermal water loss (TEWL) to assess skin moisture in order to evaluate product mildness. Instrumentation measurements of skin surface conductance will be utilized to evaluate product performance in terms of level of skin hydration.
Subjects will complete questionnaires and all adverse events will be recorded.
- Conditions
- Acne Vulgaris
- Being tested
- Clindamycin and BPO 5% gel, Clindamycin phosphate and benzoyl peroxide 2.5% gel.
- Keywords
- Healthy volunteers
- 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 and BPO 5% gelDrug
Also called Duac Topical Gel
Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide (BPO) 5% gel.
Clindamycin phosphate and benzoyl peroxide 2.5% gel.Drug
Also called ACANYA Gel
Once daily application of clindamycin phosphate and benzoyl peroxide (BPO) 2.5% gel
| Study group | Role | What they receive |
|---|---|---|
| Clindamycin and BPO 5% gel | Experimental | Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide (BPO) 5% gel. Receives: Drug: Clindamycin and BPO 5% gel |
| Clindamycin phosphate and BPO 2.5% gel | Active comparator | Once Daily application of clindamycin phosphate and benzoyl peroxide (BPO) 2.5% gel. Receives: Drug: Clindamycin phosphate and benzoyl peroxide 2.5% gel. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Erythema (Redness)
Compare tolerability of clindamycin and benzoyl peroxide (BPO) 5% and clindamycin phosphate and benzoyl peroxide 2.5% using visual assessments by an independent blinded grader.
Erythema (redness) was evaluated using the following scale:
Erythema Grade Description 0 = None 2 = Mild erythema 4 = Moderate confluent erythema 6 = Marked erythema with some edema 8 = Marked erythema, edema, possible erosion
Measured: 14 days
Skin Dryness
Visual Dryness was evaluated using the following scale:
Grade 0 = None 2 = Slight flaking 4 = Moderate flaking/scaling 6 = Marked scaling / slight fissuring 8 Severe scaling, fissuring
Measured: 14 days
Secondary outcomes (10)
Skin Moisture and Hydration
To assess skin moisture and hydration using transepidermal water loss (TEWL). Results are measured on a continuous scale as grams per meters squared (m^2) per hour. Higher values indicate greater water loss/ lower skin moisture levels.
Evaporative water loss measurements provide an instrumental assessment of skin barrier function(one of the layers of the skin. Damage leads to a disruption of the barrier that is accompanied by elevated water loss rates and affects skin moisture and hydration.
Measured: 14 days
Changes in the Skin Surface Hydration
The ability of an alternating current to flow through the stratum corneum is an indirect measure of its water content. The value recorded is expressed in microsiemens. Higher values indicate greater levels of skin hydration.
Test results were compared to measurements from the other side of the face, which was not treated instead of referring to a normal range. A normal range does not exist for this measurement. Instead, the non-treated side of the face was used as a control to determine the normal level of skin hydration.
Measured: 14 days
Subject Tolerability - Burning
At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate burning, stinging, pain, and dryness in this questionnaire. Each symptom was rated with the following scale: 0 - None, 1 - Slight, 2 - Moderate, or 3 - Severe.
The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of burning are presented here.
Measured: 2 weeks
Subject Tolerability - Stinging
At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate burning, stinging, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 - None,1 - Slight,2 - Moderate, or 3 - Severe.
The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of stinging are presented here.
Measured: 2 weeks
Subject Assessment - Dryness
At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate burning, stinging, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 - None, 1 - Slight, 2 - Moderate, or 3 - Severe.
The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of dryness are presented here.
Measured: 2 weeks
Subject Assessment - Roughness
At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate burning, stinging, roughness, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 - None, 1 - Slight, 2 - Moderate, or 3 - Severe.
The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of roughness are presented here.
Measured: 2 weeks
Subject Assessment - Pain
At each visit, panelists were supplied a self-assessment questionnaire, which included assessment of pain.
Subjects were asked to evaluate burning, stinging, pain, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 - None, 1 - Slight, 2 - Moderate, or 3 - Severe.
The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of pain are presented here.
Measured: 2 Weeks
Subject Assessment - Crusting
At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate crusting, burning, stinging, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 - None, 1 - Slight, 2 - Moderate, or 3 - Severe.
The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of crusting are presented here.
Measured: 2 Weeks
Subject Assessment - Blistering
At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate blistering, burning, stinging, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 - None, 1 - Slight, 2 - Moderate, or 3 - Severe.
The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of blistering are presented here.
Measured: 2 Weeks
Subject Assessment - Oiliness
At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate oiliness, burning, stinging, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 - None, 1 - Slight, 2 - Moderate, or 3 - Severe.
The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of oiliness are presented here.
Measured: 2 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2009 (estimated)
- Study startAug 2009
- Primary completionSep 2009
- Study completionSep 2009
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.
- 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
- 36 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
- NCT01015638
- Sponsor's protocol ID
- 114546
- Status last verified
- Mar 2017
- First submitted
- 17 Nov 2009
- Last updated
- 31 Mar 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.
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two-week Study to Determine and Compare the Tolerance and Irritation Potential of Duac® Topical Gel (Clindamycin 1% and Benzoyl Peroxide 5%) to ACANYA™ Gel (Clindamycin Phosphate 1.2% and Benzoyl Peroxide 2.5%) Topical Acne Medications
- ClinicalTrials.gov ID
- NCT01015638
- Acronym / sponsor ID
- 114546
- Conditions
- Acne Vulgaris
- Keywords
- Healthy volunteers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Stiefel, a GSK CompanyIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- Aug 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 18 Nov 2009 (estimated)
- Results
- Posted 13 Feb 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-blind (blinded expert grader) study that will enroll 25-30 healthy volunteers without facial acne. On 1 side of the face, the subject will apply 1 of the 2 test products, clindamycin and benzoyl peroxide 5% or clindamycin phosphate and benzoyl peroxide 2.5% and the other side of the face will remain non-treated to serve as a control.
Detailed description
This is a single-blind (blinded expert grader), parallel group, randomized, half-face study being conducted at one clinical site. On 1 side of the face, the subject will apply 1 of the 2 test products, clindamycin and benzoyl peroxide 5%) or clindamycin and benzoyl peroxide 2.5%) and the other side of the face will remain non-treated to serve as a control. Approximately 25-30 male and female healthy subjects without facial acne, aged 18 to 45, will be randomly assigned to each product.
The eligible subjects (screened 3 days prior to randomization) who qualify will be entered into a 2-week treatment phase. The once-daily applications for the clindamycin and benzoyl peroxide 5%and clindamycin phosphate and benzoyl peroxide 2.5%) will be supervised at the site, Monday through Friday of each week. Subjects will apply the study product at home on Saturdays and Sundays and record the times of application on a diary card.
A blinded expert grader will rate comparative product tolerance in terms of erythema and dryness on each week day (excluding Saturdays and Sundays) during the study before study product is applied.
Instruments will be used to measure transepidermal water loss (TEWL) to assess skin moisture in order to evaluate product mildness. Instrumentation measurements of skin surface conductance will be utilized to evaluate product performance in terms of level of skin hydration.
Subjects will complete questionnaires and all adverse events will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clindamycin and BPO 5% gel | Experimental | Drug: Clindamycin and BPO 5% gelOnce-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide (BPO) 5% gel. |
| Clindamycin phosphate and BPO 2.5% gel | Active comparator | Drug: Clindamycin phosphate and benzoyl peroxide 2.5% gel.Once Daily application of clindamycin phosphate and benzoyl peroxide (BPO) 2.5% gel. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol specific procedures are performed.
- Male and female subjects aged from 18 to 45 years at time of consent.
- Is willing to discontinue use of all facial products (other than the cleanser provided and makeup or razor and facial shave product) on the face for the 3 days before their baseline/day 0 visit and use only the provided facial products and their normal makeup or razor and facial shaving product for the duration of the study.
- Is willing to not change brands of makeup or razor and facial shave product during the study.
- Is willing to refrain from using any facial product on the face other than study products and their normal makeup or razor and facial shave product for the duration of the study.
Key exclusion criteria (22 listed)
- Female subjects who are pregnant, trying to become pregnant, or breast feeding.
- Male subjects that have facial beards (mustache and/or goatee is acceptable).
- Is a Type I diabetic.
- Has active or chronic skin allergies.
- Has a history of acute or chronic disease that might interfere with, or increase the risk of study participation.
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 and BPO 5% gelAlso: Duac Topical GelOnce-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide (BPO) 5% gel. | Drug | Clindamycin and BPO 5% gel |
| Clindamycin phosphate and benzoyl peroxide 2.5% gel.Also: ACANYA GelOnce daily application of clindamycin phosphate and benzoyl peroxide (BPO) 2.5% gel | Drug | Clindamycin phosphate and BPO 2.5% gel |
Primary outcome
Erythema (Redness)
Time frame: 14 days
Compare tolerability of clindamycin and benzoyl peroxide (BPO) 5% and clindamycin phosphate and benzoyl peroxide 2.5% using visual assessments by an independent blinded grader. Erythema (redness) was evaluated using the following scale: Erythema Grade Description 0 = None 2 = Mild erythema 4 = Moderate confluent erythema 6 = Marked erythema with some edema 8 = Marked erythema, edema, possible erosion
Skin Dryness
Time frame: 14 days
Visual Dryness was evaluated using the following scale: Grade 0 = None 2 = Slight flaking 4 = Moderate flaking/scaling 6 = Marked scaling / slight fissuring 8 Severe scaling, fissuring
10 secondary outcomes
Skin Moisture and Hydration
Time frame: 14 days
Changes in the Skin Surface Hydration
Time frame: 14 days
Subject Tolerability - Burning
Time frame: 2 weeks
Subject Tolerability - Stinging
Time frame: 2 weeks
Subject Assessment - Dryness
Time frame: 2 weeks
Subject Assessment - Roughness
Time frame: 2 weeks
Subject Assessment - Pain
Time frame: 2 Weeks
Subject Assessment - Crusting
Time frame: 2 Weeks
Subject Assessment - Blistering
Time frame: 2 Weeks
Subject Assessment - Oiliness
Time frame: 2 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clindamycin and BPO 5% gel and Clindamycin phosphate and benzoyl peroxide 2.5% gel. in people with Acne Vulgaris, run by Stiefel, a GSK Company at 1 site in United States.
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 7 inclusion and 22 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 31 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Yes. Results are posted in the registry (first posted 13 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?
Erythema (Redness) (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Mar 2017.