Acne VulgarisPhase 4NCT00887484
A Comparative Study of the Tolerability of Two Combination Therapies for the Treatment of Acne
A Phase 4 study testing BENZOYL PEROXIDE/ CLINDAMYCIN and BENZOYL PEROXIDE/ ADAPALENE in people with Acne Vulgaris, run by Stiefel, a GSK Company at 4 sites in Argentina.
Trial summary
The purpose of this study is to compare the tolerability of topical combination therapies in the treatment of facial acne. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- BENZOYL PEROXIDE/ CLINDAMYCIN and BENZOYL PEROXIDE/ ADAPALENE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 4 sitesArgentina
- Study dates
- Feb 2009to Jun 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects at least 21 years of age, in good general health with documented diagnosis of acne vulgaris.
- Female subjects of childbearing potential must have a negative pregnancy test. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception Abstinence is considered an acceptable method of contraception.
- Inflammatory (papules and pustules) and non-inflammatory (open and closed comedones) facial lesions.
- The ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study
- 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
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 other than acne vulgaris.
- 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.
- Use of topical antibiotics or anti-acne medications 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.
- Use of systemic retinoids within the past 6 months.
- Facial procedures performed by an esthetician, beautician, physician, nurse, or other practitioner, within the past 4 weeks or during the conduct of the study.
- Known hypersensitivity or previous allergic reaction to any of the active components, lincomycin, adapalene, clindamycin, benzoyl peroxide or excipients of the study product.
Trial locations and contacts
4 sites in 1 country.
Argentina4 sites
Centro de Investigación y Prevencion de Enfermidades Cardiovasculares
Ciudad Autonoma de Buenos Aires, Buenos Aires, 1119
Hospital Italiano de Buenos Aires
Ciudad Autonoma de Buenos Aires, Buenos Aires, 1181 ACH
LUMIPIEL - Centro Dermatológico
Ciudad Autonoma de Buenos Aires, Buenos Aires, 1181 ACH
Buenos Aires Skin
Ciudad de Buenos Aires, Buenos Aires, C1055AAO
About this study
Official title: A Single-blind, Randomized, Comparative Pilot Study Evaluating the Tolerability of Two Topical Combination Therapies in the Treatment of Acne Vulgaris
The purpose of this study is to compare the tolerability of topical combination therapies in the treatment of facial acne.
Read the detailed description
The purpose of this study is to compare the tolerability of topical combination therapies in the treatment of facial acne.
- Conditions
- Acne Vulgaris
- Being tested
- BENZOYL PEROXIDE/ CLINDAMYCIN, BENZOYL PEROXIDE/ ADAPALENE
- Keywords
- Acne, 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.
BENZOYL PEROXIDE/ CLINDAMYCINDrug
Commencing at baseline, subjects will apply once daily both treatment arm #1 and treatment arm #2 in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. At 2 weeks, subjects will apply benzoyl peroxide/clindamycin gel to the entire face for an additional 6 weeks.
BENZOYL PEROXIDE/ ADAPALENEDrug
Commencing at baseline, subjects will apply once daily both treatment arm #1 and treatment arm #2 in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. At 2 weeks, subjects will apply benzoyl peroxide/clindamycin gel to the entire face for an additional 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Clindoxyl Gel | Experimental | Subject will apply both study products in a split-face fashion. Study products will be applied once-daily in the evening. Receives: Drug: BENZOYL PEROXIDE/ CLINDAMYCIN |
| Epiduo gel | Active comparator | Subject will apply both study products in a split-face fashion. Study products will be applied once-daily in the evening. Receives: Drug: BENZOYL PEROXIDE/ ADAPALENE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Erythema (Redness)
Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.
Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.
Measured: Weeks 1 and 2
Skin Dryness
Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.
Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.
Measured: Weeks 1 and 2
Skin Peeling
Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.
Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3,Intense.
Measured: Weeks 1 and 2
Irritant/Allergic Contact Dermatitis
Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.
Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.
Measured: Weeks 1 and 2
Secondary outcomes (40)
Erythema (Redness)
Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.
Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.
Measured: Weeks 5 and 8
Skin Dryness
Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.
Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.
Measured: Weeks 5 and 8
Skin Peeling
Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.
Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.
Measured: Weeks 5 and 8
Irritant/Allergic Contact Dermatitis
Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.
Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.
Measured: Weeks 5 and 8
Investigators Static Global Assessment
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: Baseline, Weeks 5, 8
Total Acne Lesion Counts
Total acne lesion counts - includes both inflammatory acne lesions (pustules, papules), noninflammatory lesions (whiteheads and blackheads),
Measured: Baseline, Weeks 5 and 8
Inflammatory Acne Lesion Counts
Total number of inflammatory acne lesions (pustules, papules) at each timepoint.
Measured: Baseline, Weeks 5 and 8
Non-inflammatory Acne Lesion Counts
Total number of non-inflammatory acne lesions (whiteheads and blackheads) at each timepoint.
Measured: Baseline, Weeks 5 and 8
Skindex-29 Quality of Life Questionnaire (QoL) - Symptomatic Domain
Skindex-29 is a self-administered (by participants at each time point) QoL questionnaire comprised of 29 items (it.) scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 it.); symptomatic (7 it.); functional (12 it.). Domain scores range from 0 to 40, 0 to 28, and 0 to 48, respectively. Lower scores=better QoL. The symptomatic score (score=0 to 28)=(sum of the 7 individual item scores) * 100/28.
Measured: Baseline, Weeks 2 and 8
Quality of Life Questionnaire - Emotional Domain
Skindex-29 is a self-administered (by participants at each time point) QoL questionnaire comprised of 29 items (it.) scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 it.); symptomatic (7 it.); functional (12 it.). Domain scores range from 0 to 40, 0 to 28, and 0 to 48, respectively. Lower scores=better QoL. The emotional score (score=0 to 40)=(sum of the 10 individual item scores) * 100/40.
Measured: Baseline, Weeks 2 and 8
Quality of Life Questionnaire - Functional Domain
Skindex-29 is a self-administered (by participants at each time point) QoL questionnaire comprised of 29 items (it.) scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 it.); symptomatic (7 it.); functional (12 it.). Domain scores range from 0 to 40, 0 to 28, and 0 to 48, respectively. Lower scores=better QoL. The functional score (score=0 to 48)=(sum of the 12 individual item scores) * 100/48.
Measured: Baseline, Weeks 2 and 8
Quality of Life Questionnaire - Global Score
Skindex-29 is a self-administered (by participants at each time point) QoL questionnaire comprised of 29 items (it.) scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 it.); symptomatic (7 it.); functional (12 it.). Domain scores range from 0 to 40, 0 to 28, and 0 to 48, respectively. Lower scores=better QoL. A Global Score (range 0-100)=(sum of all 29 individual item scores) * 100/116.
Measured: Baseline, Weeks 2 and 8
Product Acceptability and Preference Questionnaire - Severity of Redness at Weeks 1 and 2
Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe.
Measured: Weeks 1 and 2
Product Acceptability and Preference Questionnaire - Severity of Redness at Week 8
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.
Measured: Week 8
Product Acceptability and Preference Questionnaire - Severity of Dryness at Weeks 1 and 2
Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe.
Measured: Weeks 1 and 2
Product Acceptability and Preference Questionnaire - Severity of Dryness at Week 8
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.
Measured: Week 8
Product Acceptability and Preference Questionnaire - Severity of Burning at Weeks 1 and 2
Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe.
Measured: Weeks 1 and 2
Product Acceptability and Preference Questionnaire - Severity of Burning at Week 8
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.
Measured: Week 8
Product Acceptability and Preference Questionnaire - Severity of Itching at Weeks 1 and 2
Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe.
Measured: Weeks 1 and 2
Product Acceptability and Preference Questionnaire - Severity of Itching at Week 8
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.
Measured: Week 8
Product Acceptability and Preference Questionnaire - Severity of Scaling at Weeks 1 and 2
Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe; 5, Very Severe.
Measured: Weeks 1 and 2
Product Acceptability and Preference Questionnaire - Severity of Scaling at Week 8
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 at Weeks 1 and 2
Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very easy; 2, Easy; 3, Neutral; 4, Difficult.
Measured: Weeks 1 and 2
Product Acceptability and Preference Questionnaire - Ease of Application of Product at Week 8
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.
Measured: Week 8
Product Acceptability and Preference Questionnaire - Comfort of Skin at Weeks 1 and 2
Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very Comfortable; 2, Comfortable; 3, Somewhat Comfortable; 4, Somewhat Uncomfortable; 5, Uncomfortable.
Measured: Weeks 1 and 2
Product Acceptability and Preference Questionnaire - Comfort of Skin at Week 8
Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint 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? at Weeks 1 and 2
Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following choices: Epiduo, Clindoxyl Gel, Both Treatments Equally.
Measured: Weeks 1 and 2
Product Acceptability and Preference Questionnaire - Comparison of Study Products Used in the Past at Week 8
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, Somewhat More Dissatisfied; 5, More Dissatisfied.
Measured: Week 8
Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products at Weeks 1 and 2
Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Highly Favorable; 2, Favorable; 3, Neutral; 4, Unfavorable; 5, Uncomfortable.
Measured: Weeks 1 and 2
Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products at Week 8
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, More Dissatisfied.
Measured: Week 8
Product Acceptability and Preference Questionnaire - Compliance at Weeks 1 and 2
Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, Not Compliant at all; 1, Mostly Compliant; 2, Very Compliant.
Measured: Weeks 1 and 2
Product Acceptability and Preference Questionnaire - Compliance at Week 8
Product Acceptability and Preference Questionnaire were completed by the subject at week 8 by answering Yes or No to the following question: Did you use the product every day?. When only one product was applied to the face, subjects were asked to rate their compliance by answering the aforementioned question, rather than rating compliance on a 0-2 scale.
Measured: Week 8
Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin at Weeks 1 and 2
Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint by answering Yes or No to the following question: Did you feel that your skin was hydrated and moisturized while you were on your study product?
Measured: Weeks 1 and 2
Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin at Week 8
Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint by answering Yes or No to the following question: Did you feel that your skin was hydrated and moisturized while you were on your study product?
Measured: Week 8
Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment at Week 1 and 2
Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint by answering Yes or No to the following question: If you were to choose to continue treatment for your acne, would you use the study product?
Measured: Weeks 1 and 2
Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment at Week 8
Product Acceptability and Preference Questionnaire were completed by the subject at 8 week timepoint by answering Yes or No to the following question: If you were to choose to continue treatment for your acne, would you use the study product?
Measured: Week 8
Product Acceptability and Preference Questionnaire - Ease of Use Wtih Make-Up at Weeks 1 and 2
Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, Not Applicable; 1, Very Easy; 2, Easy; 3, Neutral; 4, Difficult; 5, Very Difficult.
Measured: Weeks 1 and 2
Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up at Week 8
Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, Not Applicable; 1, Very Easy; 2, Easy; 3, Neutral; 4, Difficult; 5, Very Difficult.
Measured: Week 8
Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product at Weeks 1 and 2
Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very Satisfied; 2, Satisfied; 3, Neutral; 4, Unsatisfied; 5, Very Unsatisfied.
Measured: Weeks 1 and 2
Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product at Week 8
Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint 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.
- First posted24 Apr 2009 (estimated)
- Study startFeb 2009
- Primary completionJun 2009
- Study completionJun 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
- 50 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
- NCT00887484
- Sponsor's protocol ID
- 114544
- Status last verified
- Oct 2016
- First submitted
- 23 Apr 2009
- Last updated
- 13 Dec 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-blind, Randomized, Comparative Pilot Study Evaluating the Tolerability of Two Topical Combination Therapies in the Treatment of Acne Vulgaris
- ClinicalTrials.gov ID
- NCT00887484
- Acronym / sponsor ID
- 114544
- Conditions
- Acne Vulgaris
- Keywords
- Acne, Acne Vulgaris
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Stiefel, a GSK CompanyIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- Feb 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 24 Apr 2009 (estimated)
- Results
- Posted 23 Oct 2012
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 tolerability of topical combination therapies in the treatment of facial acne.
Detailed description
The purpose of this study is to compare the tolerability of topical combination therapies in the treatment of facial acne.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clindoxyl Gel | Experimental | Drug: BENZOYL PEROXIDE/ CLINDAMYCINSubject will apply both study products in a split-face fashion. Study products will be applied once-daily in the evening. |
| Epiduo gel | Active comparator | Drug: BENZOYL PEROXIDE/ ADAPALENESubject will apply both study products in a split-face fashion. Study products will be applied once-daily in the evening. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female subjects at least 21 years of age, in good general health with documented diagnosis of acne vulgaris.
- Female subjects of childbearing potential must have a negative pregnancy test. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception Abstinence is considered an acceptable method of contraception.
- Inflammatory (papules and pustules) and non-inflammatory (open and closed comedones) facial lesions.
- The ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study
- 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
Key exclusion criteria (8 listed)
- Female subjects who are pregnant, trying to become pregnant or breastfeeding.
- Subjects who have any clinically relevant finding at their baseline physical other than acne vulgaris.
- 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.
- Use of topical antibiotics or anti-acne medications 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.
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 |
|---|---|---|
| BENZOYL PEROXIDE/ CLINDAMYCINCommencing at baseline, subjects will apply once daily both treatment arm #1 and treatment arm #2 in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. At 2 weeks, subjects will apply benzoyl peroxide/clindamycin gel to the entire face for an additional 6 weeks. | Drug | Clindoxyl Gel |
| BENZOYL PEROXIDE/ ADAPALENECommencing at baseline, subjects will apply once daily both treatment arm #1 and treatment arm #2 in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. At 2 weeks, subjects will apply benzoyl peroxide/clindamycin gel to the entire face for an additional 6 weeks. | Drug | Epiduo gel |
Primary outcome
Erythema (Redness)
Time frame: Weeks 1 and 2
Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face. Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.
Skin Dryness
Time frame: Weeks 1 and 2
Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face. Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.
Skin Peeling
Time frame: Weeks 1 and 2
Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face. Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3,Intense.
Irritant/Allergic Contact Dermatitis
Time frame: Weeks 1 and 2
Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face. Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.
40 secondary outcomes
Erythema (Redness)
Time frame: Weeks 5 and 8
Skin Dryness
Time frame: Weeks 5 and 8
Skin Peeling
Time frame: Weeks 5 and 8
Irritant/Allergic Contact Dermatitis
Time frame: Weeks 5 and 8
Investigators Static Global Assessment
Time frame: Baseline, Weeks 5, 8
Total Acne Lesion Counts
Time frame: Baseline, Weeks 5 and 8
Inflammatory Acne Lesion Counts
Time frame: Baseline, Weeks 5 and 8
Non-inflammatory Acne Lesion Counts
Time frame: Baseline, Weeks 5 and 8
Skindex-29 Quality of Life Questionnaire (QoL) - Symptomatic Domain
Time frame: Baseline, Weeks 2 and 8
Quality of Life Questionnaire - Emotional Domain
Time frame: Baseline, Weeks 2 and 8
Quality of Life Questionnaire - Functional Domain
Time frame: Baseline, Weeks 2 and 8
Quality of Life Questionnaire - Global Score
Time frame: Baseline, Weeks 2 and 8
Product Acceptability and Preference Questionnaire - Severity of Redness at Weeks 1 and 2
Time frame: Weeks 1 and 2
Product Acceptability and Preference Questionnaire - Severity of Redness at Week 8
Time frame: Week 8
Product Acceptability and Preference Questionnaire - Severity of Dryness at Weeks 1 and 2
Time frame: Weeks 1 and 2
Product Acceptability and Preference Questionnaire - Severity of Dryness at Week 8
Time frame: Week 8
Product Acceptability and Preference Questionnaire - Severity of Burning at Weeks 1 and 2
Time frame: Weeks 1 and 2
Product Acceptability and Preference Questionnaire - Severity of Burning at Week 8
Time frame: Week 8
Product Acceptability and Preference Questionnaire - Severity of Itching at Weeks 1 and 2
Time frame: Weeks 1 and 2
Product Acceptability and Preference Questionnaire - Severity of Itching at Week 8
Time frame: Week 8
Product Acceptability and Preference Questionnaire - Severity of Scaling at Weeks 1 and 2
Time frame: Weeks 1 and 2
Product Acceptability and Preference Questionnaire - Severity of Scaling at Week 8
Time frame: Week 8
Product Acceptability and Preference Questionnaire - Ease of Application of Product at Weeks 1 and 2
Time frame: Weeks 1 and 2
Product Acceptability and Preference Questionnaire - Ease of Application of Product at Week 8
Time frame: Week 8
Product Acceptability and Preference Questionnaire - Comfort of Skin at Weeks 1 and 2
Time frame: Weeks 1 and 2
Product Acceptability and Preference Questionnaire - Comfort of Skin at Week 8
Time frame: Week 8
Product Acceptability and Preference Questionnaire - Which Study Product is Subject More Satisfied With? at Weeks 1 and 2
Time frame: Weeks 1 and 2
Product Acceptability and Preference Questionnaire - Comparison of Study Products Used in the Past at Week 8
Time frame: Week 8
Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products at Weeks 1 and 2
Time frame: Weeks 1 and 2
Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products at Week 8
Time frame: Week 8
Product Acceptability and Preference Questionnaire - Compliance at Weeks 1 and 2
Time frame: Weeks 1 and 2
Product Acceptability and Preference Questionnaire - Compliance at Week 8
Time frame: Week 8
Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin at Weeks 1 and 2
Time frame: Weeks 1 and 2
Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin at Week 8
Time frame: Week 8
Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment at Week 1 and 2
Time frame: Weeks 1 and 2
Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment at Week 8
Time frame: Week 8
Product Acceptability and Preference Questionnaire - Ease of Use Wtih Make-Up at Weeks 1 and 2
Time frame: Weeks 1 and 2
Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up at Week 8
Time frame: Week 8
Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product at Weeks 1 and 2
Time frame: Weeks 1 and 2
Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product at Week 8
Time frame: Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2016.
- 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
4 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 BENZOYL PEROXIDE/ CLINDAMYCIN and BENZOYL PEROXIDE/ ADAPALENE in people with Acne Vulgaris, run by Stiefel, a GSK Company at 4 sites in Argentina.
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 5 inclusion and 8 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 13 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Argentina. 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 23 Oct 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: Weeks 1 and 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?
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 13 Dec 2016.