Acne VulgarisPhase 4NCT00964223

A Study to Evaluate Tolerability of Two Topical Drug Products in the Treatment of Facial Acne

A Phase 4 study testing Clindamycin and benzoyl peroxide gel (Duac® Topical Gel) and benzoyl peroxide and adapalene gel (EPIDUO™ Gel) in people with Acne Vulgaris, run by Stiefel, a GSK Company at 2 sites in United States.

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

Multi-center, single-blind, randomized, comparative, split-face study. The duration of the study is 8 weeks. Commencing at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide gel and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Acne Vulgaris
What is being tested?: Clindamycin and benzoyl peroxide gel (Duac® Topical Gel) and benzoyl peroxide and adapalene gel (EPIDUO™ Gel)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 2 sitesUnited States
Study dates: Jul 2009to Nov 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female subjects at least 18 years of age, in good general health with documented diagnosis of facial acne vulgaris.
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.
Subjects willing to follow therapeutic instructions including avoidance of any other topical facial or systemic acne therapy during the conduct of the study.
Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol specific procedures are performed.

Who cannot join

Female subjects who are pregnant, trying to become pregnant or breastfeeding.
Subjects who have any clinically relevant finding at their baseline physical examination or medical history such as severe systemic diseases, 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 (e.g., ulcerative colitis, pseudomembranous colitis, chronic diarrhea, or a history of antibiotic-associated colitis) or similar symptoms.
Use of topical antibiotics on the face and systemic antibiotics within the past 2 and 4 weeks, respectively.
Use of 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.

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Use of systemic retinoids within the past 6 months.
Concurrent use of drugs known to be photosensitizers (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, 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.
Use of topical anti-acne medications within the past 2 weeks.
Use of any investigational drugs or treatments during the study or within 4 weeks of the baseline visit.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Aesthetics, Skin Care & Dermasurgery
Rockville, Maryland, 20850
Grekin Skin Institute
Warren, Michigan, 48088

Other trials in United States

About this study

Official title: A Single-blind, Randomized, Comparative Split-face Study Evaluating the Tolerability of Clindamycin and Benzoyl Peroxide Gel to Benzoyl Peroxide/Adapalene Gel in the Treatment of Acne Vulgaris.

Read the detailed description

Multi-center, single-blind, randomized, comparative, split-face study. The duration of the study is 8 weeks and consists of a baseline visit and visits at weeks 1, 2, 5 and 8. Commencing at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide gel and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3 subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.

Blinding This is an investigator-blinded study; therefore, subjects and study-center staff will not be blinded to study treatment allocation (ie, left vs. right side application). During the first 2 weeks, the investigator will be unaware of which study product is being used on either side of the face. Subjects and study-center staff will be instructed not to reveal study treatment allocation to the investigator. Subjects will be instructed not to use study product in the presence of the investigator.

Conditions: Acne Vulgaris
Being tested: Clindamycin and benzoyl peroxide gel (Duac® Topical Gel), benzoyl peroxide and adapalene gel (EPIDUO™ Gel)
Keywords: Acne 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.

Clindamycin and benzoyl peroxide gel (Duac® Topical Gel)Drug
Also called Duac® Topical Gel
Subjects will apply Duac(clindamycin and benzoyl peroxide) gel to one-half of their face and and apply Epiduo (benzoyl peroxide/adapalene) gel on the other side of their face once a day for the first 2 weeks. Starting at week 2, subjects will apply Duac (benzoyl peroxide/clindamycin gel) to the entire face for an additional 6 weeks.
benzoyl peroxide and adapalene gel (EPIDUO™ Gel)Drug
Also called EPIDUO™ Gel
Subjects will apply Duac(clindamycin and benzoyl peroxide) gel to one-half of their face and and apply Epiduo (benzoyl peroxide/adapalene) gel on the other side of their face once a day for the first 2 weeks. Starting at week 2, subjects will apply Duac (benzoyl peroxide/clindamycin gel) to the entire face for an additional 6 weeks.

Study groups in NCT00964223
Study group	Role	What they receive
Duac gel	Experimental	Subjects will apply Duac gel once a day to one-half of their face and and apply Epiduo gel on the other side of their face once daily for the first 2 weeks. Receives: Drug: Clindamycin and benzoyl peroxide gel (Duac® Topical Gel)
Epiduo gel	Active comparator	Subjects will apply Duac gel once a day to one-half of their face and and apply Epiduo gel on the other side of their face once daily for the first 2 weeks. Receives: Drug: benzoyl peroxide and adapalene gel (EPIDUO™ Gel)

What is being measured

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

Skin Dryness Score
Investigator assessment of tolerability (skin dryness) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.
Measured: Week 1, Week 2
Skin Peeling Score
Investigator assessment of tolerability (skin peeling) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; Intense, 3.
Measured: Week 1, Week 2
Irritant/Allergic Contact Dermatitis Score
Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis) on the face.
Erythema,peeling, and dryness were graded using the following scale:
0 None
1. Slight
2. Moderate
3. Intense
Measured: Week 1, Week 2
Erythema (Redness) Score
Investigator assessment of tolerability (irritant/allergic contact dermatitis) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.
Measured: Week 1, Week 2

Secondary outcomes (40)

Erythema (Redness) Score
Investigator assessment of tolerability (erythema) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.
Measured: Week 5, Week 8
Skin Dryness Score
Investigator assessment of tolerability (skin dryness) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.
Measured: Week 5, Week 8
Skin Peeling Score
Investigator assessment of tolerability (skin peeling) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.
Measured: Week 5, Week 8
Irritant/Allergic Contact Dermatitis Score
Investigator assessment of tolerability (contact dermatitis) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.
Measured: Week 5, Week 8
Investigator Static Global Assessment Score
ISGA is evaluated using the following scale: 0, clear, clear skin with no lesions; 1, almost clear, rare non-inflammatory lesions; 2, mild, some non-inflammatory lesions with no more than a few inflammatory lesions but no nodular lesions; 3, moderate, up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than 1 small nodular lesion; 4, severe, up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions; 5, very severe, many non-inflammatory and inflammatory lesions and more than a few nodular lesions. May have cystic lesions.
Measured: Week 5, Week 8
Inflammatory Acne Lesion Counts
Total number of inflammatory acne lesions (pustules, papules) at each timepoint.
Measured: Week 5, Week 8
Non-Inflammatory Acne Lesion Counts
Total number of non-inflammatory acne lesions (whiteheads and blackheads) at each timepoint.
Measured: Week 5, Week 8
Total Acne Lesion Counts
Total acne lesion counts - includes both inflammatory acne lesions (pustules, papules), noninflammatory lesions (whiteheads and blackheads),
Measured: Week 5, Week 8
Skindex-29 Quality of Life Questionnaire - Symptomatic Domain
Skindex-29 Quality of Life (QoL) Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: "never" to "all the time", higher scores for each domain indicate worse effects on QoL. Scores range from 0 to 100. Higher scores indicate worse QoL for that domain.
Measured: Baseline, and Week 8
Skindex-29 Quality of Life Questionnaire - Emotional Domain
Skindex-29 Quality of Life (QoL)Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: "never" to "all the time", higher scores for each domain indicate worse effects on QoL. Scores range from 0 to 100. Higher scores indicate worse QoL for that domain.
Measured: Baseline, and Week 8
Skindex-29 Quality of Life Questionnaire - Functional Domain
Skindex-29 Quality of Life (QoL)Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: "never" to "all the time", higher scores for each domain indicate worse effects on QoL. Scores range from 0 to 100. Higher scores indicate worse QoL for that domain.
Measured: Baseline, and Week 8
Skindex-29 Quality of Life Questionnaire - Global Score
Skindex-29 Quality of Life (QoL)Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: "never" to "all the time", higher scores for each domain indicate worse effects on QoL. The Global Score ranges from 0 to 100. Higher scores indicate worse QoL for that domain.
Measured: Baseline, and Week 8
Product Acceptability and Preference Questionnaire - Severity of Redness
Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.
Measured: Week 1, Week 2
Product Acceptability and Preference Questionnaire - Severity of Redness
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.
Measured: Week 8
Product Acceptability and Preference Questionnaire - Severity of Dryness
Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.
Measured: Week 1, Week 2
Product Acceptability and Preference Questionnaire - Severity of Dryness
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.
Measured: Week 8
Product Acceptability and Preference Questionnaire - Severity of Burning
Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.
Measured: Week 1, Week 2
Product Acceptability and Preference Questionnaire - Severity of Burning
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.
Measured: Week 8
Product Acceptability and Preference Questionnaire - Severity of Itching
Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.
Measured: Week 1, Week 2
Product Acceptability and Preference Questionnaire - Severity of Itching
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.
Measured: Week 8
Product Acceptability and Preference Questionnaire - Severity of Scaling
Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.
Measured: Week 1, Week 2
Product Acceptability and Preference Questionnaire - Severity of Scaling
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.
Measured: Week 8
Product Acceptability and Preference Questionnaire - Ease of Application of Product
Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, very easy; 2, easy; 3, neutral; 4, difficult; 5, very difficult.
Measured: Week 1, Week 2
Product Acceptability and Preference Questionnaire - Ease of Application of Product
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, very easy; 2, easy; 3, neutral; 4, difficult; 5, very difficult.
Measured: Week 8
Product Acceptability and Preference Questionnaire - Comfort of Skin
Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, very comfortable; 2, comfortable; 3, somewhat comfortable; 4, somewhat uncomfortable; 5, uncomfortable.
Measured: Week 1, Week 2
Product Acceptability and Preference Questionnaire - Comfort of Skin
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, very comfortable; 2, comfortable; 3, somewhat comfortable; 4, somewhat uncomfortable; 5, uncomfortable.
Measured: Week 8
Product Acceptability and Preference Questionnaire - Which Study Product is Subject More Satisfied With?
Product Acceptability and Preference Questionnaire was completed by the subject at week 1 and week 2 asking which study product they were more satisfied with: Duac or Epiduo.
Measured: Week 1, Week 2
Product Acceptability and Preference Questionnaire - Comparison of Study Products to Products Used in the Past
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, more satisfied; 2, somewhat more satisfied; 3, neither satisfied or dissatisfied; 4, more satisfied; 5, more dissatisfied.
Measured: Week 8
Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products
Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, highly favorable; 2, favorable; 3, neutral; 4, unfavorable; 5, highly unfavorable.
Measured: Week 1, Week 2
Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, highly favorable; 2, favorable; 3, neutral; 4, unfavorable; 5, highly unfavorable.
Measured: Week 8
Product Acceptability and Preference Questionnaire - Compliance
Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, non-compliant (< 50% of the week); 1, mostly compliant (50-79%); 2, very compliant (80-100%).
Measured: Week 1, Week 2
Product Acceptability and Preference Questionnaire - Compliance
Subject response to question regarding use of the product every day or not at week 8 time point answering Yes or No
Measured: Week 8
Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin
Subject response to question: did you feel that your skin was hydrated and moisturized while you on your study product? (Yes or No).
Measured: Week 1, Week 2
Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin
Subject response to question: did you feel that your skin was hydrated and moisturized while you on your study product? (Yes or No).
Measured: Week 8
Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment
Subject response to the following question: If you were to choose to continue treatment for your acne, which treatment would you choose? (Yes or No).
Measured: Week 1, Week 2
Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment
Subject response to the following question: If you were to choose to continue treatment for your acne, which treatment would you choose? (Yes or No).
Measured: Week 8
Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up
Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, not applicable; 1, very easy; 2, easy; 3, neutral; 4, difficult.
Measured: Week 1, Week 2
Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up
Measure Description Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, not applicable; 1, very easy; 2, easy; 3, neutral; 4, difficult.
Measured: Week 8
Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product
Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, very satisfied; 2, satisfied; 3, neutral; 4, unsatisfied; 5, very unsatisfied.
Measured: Week 1, Week 2
Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, very satisfied; 2, satisfied; 3, neutral; 4, unsatisfied; 5, very unsatisfied.
Measured: Week 8

Timeline

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

Jul 2009Nov 2009

First posted24 Aug 2009 (estimated)
Study startJul 2009
Primary completionNov 2009
Study completionNov 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.
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: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00964223
Sponsor's protocol ID: 114547
Status last verified: Oct 2016
First submitted: 20 Aug 2009
Last updated: 23 Nov 2016
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

Gonzalez P, Vila R, Cirigliano M. The tolerability profile of clindamycin 1%/benzoyl peroxide 5% gel vs. adapalene 0.1%/benzoyl peroxide 2.5% gel for facial acne: results of a randomized, single-blind, split-face study. J Cosmet Dermatol. 2012 Dec;11(4):251-60. doi: 10.1111/jocd.12013.
PubMed 23174047

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 23 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-blind, Randomized, Comparative Split-face Study Evaluating the Tolerability of Clindamycin and Benzoyl Peroxide Gel to Benzoyl Peroxide/Adapalene Gel in the Treatment of Acne Vulgaris.
ClinicalTrials.gov ID: NCT00964223
Acronym / sponsor ID: 114547
Conditions: Acne Vulgaris
Keywords: Acne vulgaris
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Stiefel, a GSK CompanyIndustry (pharma, biotech, devices)
Collaborators: GlaxoSmithKline
Study start: Jul 2009
Primary completion: Nov 2009 (actual)
Study completion: Nov 2009 (actual)
First posted: 24 Aug 2009 (estimated)
Results: Posted 25 Aug 2011

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 (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Duac gel	Experimental	Drug: Clindamycin and benzoyl peroxide gel (Duac® Topical Gel)Subjects will apply Duac gel once a day to one-half of their face and and apply Epiduo gel on the other side of their face once daily for the first 2 weeks.
Epiduo gel	Active comparator	Drug: benzoyl peroxide and adapalene gel (EPIDUO™ Gel)Subjects will apply Duac gel once a day to one-half of their face and and apply Epiduo gel on the other side of their face once daily for the first 2 weeks.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Male or female subjects at least 18 years of age, in good general health with documented diagnosis of facial acne vulgaris.
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.
Subjects willing to follow therapeutic instructions including avoidance of any other topical facial or systemic acne therapy during the conduct of the study.
Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol specific procedures are performed.

Key exclusion criteria (11 listed)

Female subjects who are pregnant, trying to become pregnant or breastfeeding.
Subjects who have any clinically relevant finding at their baseline physical examination or medical history such as severe systemic diseases, 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 (e.g., ulcerative colitis, pseudomembranous colitis, chronic diarrhea, or a history of antibiotic-associated colitis) or similar symptoms.
Use of topical antibiotics on the face and 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
Clindamycin and benzoyl peroxide gel (Duac® Topical Gel)Also: Duac® Topical GelSubjects will apply Duac(clindamycin and benzoyl peroxide) gel to one-half of their face and and apply Epiduo (benzoyl peroxide/adapalene) gel on the other side of their face once a day for the first 2 weeks. Starting at week 2, subjects will apply Duac (benzoyl peroxide/clindamycin gel) to the entire face for an additional 6 weeks.	Drug	Duac gel
benzoyl peroxide and adapalene gel (EPIDUO™ Gel)Also: EPIDUO™ GelSubjects will apply Duac(clindamycin and benzoyl peroxide) gel to one-half of their face and and apply Epiduo (benzoyl peroxide/adapalene) gel on the other side of their face once a day for the first 2 weeks. Starting at week 2, subjects will apply Duac (benzoyl peroxide/clindamycin gel) to the entire face for an additional 6 weeks.	Drug	Epiduo gel

Primary outcome

Skin Dryness Score
Time frame: Week 1, Week 2
Investigator assessment of tolerability (skin dryness) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.
Skin Peeling Score
Time frame: Week 1, Week 2
Investigator assessment of tolerability (skin peeling) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; Intense, 3.
Irritant/Allergic Contact Dermatitis Score
Time frame: Week 1, Week 2
Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis) on the face. Erythema,peeling, and dryness were graded using the following scale: 0 None 1. Slight 2. Moderate 3. Intense
Erythema (Redness) Score
Time frame: Week 1, Week 2
Investigator assessment of tolerability (irritant/allergic contact dermatitis) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.

40 secondary outcomes

Erythema (Redness) Score
Time frame: Week 5, Week 8
Skin Dryness Score
Time frame: Week 5, Week 8
Skin Peeling Score
Time frame: Week 5, Week 8
Irritant/Allergic Contact Dermatitis Score
Time frame: Week 5, Week 8
Investigator Static Global Assessment Score
Time frame: Week 5, Week 8
Inflammatory Acne Lesion Counts
Time frame: Week 5, Week 8
Non-Inflammatory Acne Lesion Counts
Time frame: Week 5, Week 8
Total Acne Lesion Counts
Time frame: Week 5, Week 8
Skindex-29 Quality of Life Questionnaire - Symptomatic Domain
Time frame: Baseline, and Week 8
Skindex-29 Quality of Life Questionnaire - Emotional Domain
Time frame: Baseline, and Week 8
Skindex-29 Quality of Life Questionnaire - Functional Domain
Time frame: Baseline, and Week 8
Skindex-29 Quality of Life Questionnaire - Global Score
Time frame: Baseline, and Week 8
Product Acceptability and Preference Questionnaire - Severity of Redness
Time frame: Week 1, Week 2
Product Acceptability and Preference Questionnaire - Severity of Redness
Time frame: Week 8
Product Acceptability and Preference Questionnaire - Severity of Dryness
Time frame: Week 1, Week 2
Product Acceptability and Preference Questionnaire - Severity of Dryness
Time frame: Week 8
Product Acceptability and Preference Questionnaire - Severity of Burning
Time frame: Week 1, Week 2
Product Acceptability and Preference Questionnaire - Severity of Burning
Time frame: Week 8
Product Acceptability and Preference Questionnaire - Severity of Itching
Time frame: Week 1, Week 2
Product Acceptability and Preference Questionnaire - Severity of Itching
Time frame: Week 8
Product Acceptability and Preference Questionnaire - Severity of Scaling
Time frame: Week 1, Week 2
Product Acceptability and Preference Questionnaire - Severity of Scaling
Time frame: Week 8
Product Acceptability and Preference Questionnaire - Ease of Application of Product
Time frame: Week 1, Week 2
Product Acceptability and Preference Questionnaire - Ease of Application of Product
Time frame: Week 8
Product Acceptability and Preference Questionnaire - Comfort of Skin
Time frame: Week 1, Week 2
Product Acceptability and Preference Questionnaire - Comfort of Skin
Time frame: Week 8
Product Acceptability and Preference Questionnaire - Which Study Product is Subject More Satisfied With?
Time frame: Week 1, Week 2
Product Acceptability and Preference Questionnaire - Comparison of Study Products to Products Used in the Past
Time frame: Week 8
Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products
Time frame: Week 1, Week 2
Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products
Time frame: Week 8
Product Acceptability and Preference Questionnaire - Compliance
Time frame: Week 1, Week 2
Product Acceptability and Preference Questionnaire - Compliance
Time frame: Week 8
Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin
Time frame: Week 1, Week 2
Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin
Time frame: Week 8
Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment
Time frame: Week 1, Week 2
Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment
Time frame: Week 8
Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up
Time frame: Week 1, Week 2
Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up
Time frame: Week 8
Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product
Time frame: Week 1, Week 2
Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product
Time frame: Week 8

Results and safety

Results posted to the registry on 25 Aug 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Study Participants	28	28

Primary outcome: Skin Dryness Score

Time frame: Week 1, Week 2. Mean (Standard Deviation). Unit: Units on a scale

Measure	Duac Gel n = 28	Epiduo Gel n = 28
Week 1	0.15 (0.37)	0.46 (0.71)
Week 2	0.14 (0.36)	0.29 (0.53)

Population analysed: Intent-to-Treat (ITT) Population

Primary outcome: Skin Peeling Score

Time frame: Week 1, Week 2. Mean (Standard Deviation). Unit: Units on a scale

Measure	Duac Gel n = 28	Epiduo Gel n = 28
Week 1	0.15 (0.37)	0.54 (0.71)
Week 2	0.18 (0.39)	0.21 (0.50)

Population analysed: ITT

Primary outcome: Irritant/Allergic Contact Dermatitis Score

Time frame: Week 1, Week 2. Mean (Standard Deviation). Unit: Units on a scale

Measure	Duac Gel n = 28	Epiduo Gel n = 28
Week 1	0.00 (0.00)	0.15 (0.46)
Week 2	0.00 (0.00)	0.00 (0.00)

Population analysed: ITT

Primary outcome: Erythema (Redness) Score

Time frame: Week 1, Week 2. Mean (Standard Deviation). Unit: Units on a scale

Measure	Duac Gel n = 28	Epiduo Gel n = 28
Week 1	0.27 (0.53)	0.58 (0.81)
Week 2	0.18 (0.39)	0.36 (0.49)

Population analysed: ITT

40 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Study Participants	0 of 28 (0%)	0 of 28 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 23174047Gonzalez P, Vila R, Cirigliano M. The tolerability profile of clindamycin 1%/benzoyl peroxide 5% gel vs. adapalene 0.1%/benzoyl peroxide 2.5% gel for facial acne: results of a randomized, single-blind, split-face study. J Cosmet Dermatol. 2012 Dec;11(4):251-60. doi: 10.1111/jocd.12013.
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

2 sites in 1 country: see every site and its status.

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 4 inclusion and 11 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 23 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 25 Aug 2011). 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?

Skin Dryness Score (time frame: Week 1, Week 2). The study lists 4 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 NCT00964223, 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 23 Nov 2016.