Last updated: 11/07/2018 07:51:29
Compare the Tolerance of Clindamycin 1% /benzoyl peroxide (BPO) 5% Gel to Clindamycin 1.2%/ BPO 2.5% Topical Medications
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Single (Investigator)
Allocation:
Randomized
Primary outcomes:
Erythema (redness)
Timeframe: 14 days
Skin Dryness
Timeframe: 14 days
Secondary outcomes:
Skin moisture and hydration
Timeframe: 14 days
Changes in the skin surface hydration
Timeframe: 14 days
Subject tolerability - Burning
Timeframe: 2 weeks
Subject Tolerability - stinging
Timeframe: 2 weeks
Subject assessment - dryness
Timeframe: 2 weeks
Subject assessment - Roughness
Timeframe: 2 weeks
Subject Assessment - Pain
Timeframe: 2 Weeks
Subject Assessment - Crusting
Timeframe: 2 Weeks
Subject Assessment - Blistering
Timeframe: 2 Weeks
Subject Assessment - Oiliness
Timeframe: 2 Weeks
Interventions:
Drug: Clindamycin and BPO 5% gel
Drug: Clindamycin phosphate and benzoyl peroxide 2.5% gel.
Enrollment:
36
Observational study model:
Not applicable
Primary completion date:
2009-01-09
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Acne Vulgaris
Product
benzoyl peroxide, benzoyl peroxide/clindamycin phosphate, clindamycin phosphate
Collaborators
GSK
Study date(s)
August 2009 to September 2009
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18 - 45 years
Accepts healthy volunteers
Yes
- 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.
- Female subjects who are pregnant, trying to become pregnant, or breast feeding.
- Male subjects that have facial beards (mustache and/or goatee is acceptable).
Inclusion and exclusion criteria
Inclusion criteria:
- 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
Exclusion criteria:
- 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.
- 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 location(s)
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
2009-01-09
Actual study completion date
2009-01-09
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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