Last updated: 11/07/2018 07:50:58
A Comparative study of the Tolerability of Two Combination Therapies for the Treatment of Acne
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A single-blind, randomized, comparative pilot study evaluating the tolerability of two topical combination therapies in the treatment of acne vulgaris
Trial description: The purpose of this study is to compare the tolerability of topical combination therapies in the treatment of facial acne.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Single (Investigator)
Allocation:
Randomized
Primary outcomes:
Erythema (redness)
Timeframe: Weeks 1 and 2
Skin dryness
Timeframe: Weeks 1 and 2
Skin Peeling
Timeframe: Weeks 1 and 2
Irritant/allergic contact dermatitis
Timeframe: Weeks 1 and 2
Secondary outcomes:
Erythema (redness)
Timeframe: Weeks 5 and 8
Skin dryness
Timeframe: Weeks 5 and 8
Skin Peeling
Timeframe: Weeks 5 and 8
Irritant/allergic contact dermatitis
Timeframe: Weeks 5 and 8
Investigators Static Global Assessment
Timeframe: Baseline, Weeks 5, 8
Total acne lesion counts
Timeframe: Baseline, Weeks 5 and 8
Inflammatory acne lesion counts
Timeframe: Baseline, Weeks 5 and 8
Non-inflammatory acne lesion counts
Timeframe: Baseline, Weeks 5 and 8
Skindex-29 Quality of Life Questionnaire (QoL) - Symptomatic Domain
Timeframe: Baseline, Weeks 2 and 8
Quality of Life Questionnaire - Emotional Domain
Timeframe: Baseline, Weeks 2 and 8
Quality of Life Questionnaire - Functional Domain
Timeframe: Baseline, Weeks 2 and 8
Quality of Life Questionnaire - Global Score
Timeframe: Baseline, Weeks 2 and 8
Product Acceptability and Preference Questionnaire - Severity of Redness at Weeks 1 and 2
Timeframe: Weeks 1 and 2
Product Acceptability and Preference Questionnaire - Severity of Redness at Week 8
Timeframe: Week 8
Product Acceptability and Preference Questionnaire - Severity of Dryness at Weeks 1 and 2
Timeframe: Weeks 1 and 2
Product Acceptability and Preference Questionnaire - Severity of Dryness at Week 8
Timeframe: Week 8
Product Acceptability and Preference Questionnaire - Severity of Burning at Weeks 1 and 2
Timeframe: Weeks 1 and 2
Product Acceptability and Preference Questionnaire - Severity of Burning at Week 8
Timeframe: Week 8
Product Acceptability and Preference Questionnaire - Severity of Itching at Weeks 1 and 2
Timeframe: Weeks 1 and 2
Product Acceptability and Preference Questionnaire - Severity of Itching at Week 8
Timeframe: Week 8
Product Acceptability and Preference Questionnaire - Severity of Scaling at Weeks 1 and 2
Timeframe: Weeks 1 and 2
Product Acceptability and Preference Questionnaire - Severity of Scaling at Week 8
Timeframe: Week 8
Product Acceptability and Preference Questionnaire - Ease of Application of Product at Weeks 1 and 2
Timeframe: Weeks 1 and 2
Product Acceptability and Preference Questionnaire - Ease of Application of Product at Week 8
Timeframe: Week 8
Product Acceptability and Preference Questionnaire - Comfort of Skin at Weeks 1 and 2
Timeframe: Weeks 1 and 2
Product Acceptability and Preference Questionnaire - Comfort of Skin at Week 8
Timeframe: Week 8
Product Acceptability and Preference Questionnaire - Which Study Product is Subject More Satisfied with? at Weeks 1 and 2
Timeframe: Weeks 1 and 2
Product Acceptability and Preference Questionnaire - Comparison of Study Products Used in the Past at Week 8
Timeframe: Week 8
Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products at Weeks 1 and 2
Timeframe: Weeks 1 and 2
Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products at Week 8
Timeframe: Week 8
Product Acceptability and Preference Questionnaire - Compliance at Weeks 1 and 2
Timeframe: Weeks 1 and 2
Product Acceptability and Preference Questionnaire - Compliance at Week 8
Timeframe: Week 8
Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin at Weeks 1 and 2
Timeframe: Weeks 1 and 2
Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin at Week 8
Timeframe: Week 8
Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment at Week 1 and 2
Timeframe: Weeks 1 and 2
Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment at Week 8
Timeframe: Week 8
Product Acceptability and Preference Questionnaire - Ease of Use wtih Make-Up at Weeks 1 and 2
Timeframe: Weeks 1 and 2
Product Acceptability and Preference Questionnaire - Ease of Use with Make-Up at Week 8
Timeframe: Week 8
Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product at Weeks 1 and 2
Timeframe: Weeks 1 and 2
Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product at Week 8
Timeframe: Week 8
Interventions:
Drug: BENZOYL PEROXIDE/ CLINDAMYCIN
Drug: BENZOYL PEROXIDE/ ADAPALENE
Enrollment:
50
Observational study model:
Not applicable
Primary completion date:
2009-03-06
Time perspective:
Not applicable
Clinical 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 Clin Aesthet Dematol. 2012;11:251-260.
Medical condition
Acne Vulgaris
Product
GSK3732923, adapalene, benzoyl peroxide, benzoyl peroxide/clindamycin phosphate, clindamycin phosphate, clindamycin phosphate/tretinoin, tretinoin
Collaborators
GSK
Study date(s)
February 2009 to June 2009
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
21+ years
Accepts healthy volunteers
No
- 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.
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- 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
Exclusion criteria:
- 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 location(s)
Location
LUMIPIEL - Centro Dermatológico
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1181 ACH
Status
Study Complete
Location
Centro de Investigación y Prevencion de Enfermidades Cardiovasculares
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1119
Status
Study Complete
Location
Buenos Aires Skin
Ciudad de Buenos Aires, Buenos Aires, Argentina, C1055AAO
Status
Study Complete
Location
Hospital Italiano de Buenos Aires
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1181 ACH
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2009-03-06
Actual study completion date
2009-03-06
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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