Last updated: 04/30/2019 17:00:18
A randomized, evaluator-blind, single-center, parallel-group clinical study designed to evaluate the local tolerance of two facial cleansers containing Benzoyl Peroxide (BPO) in comparison to a commercial control in healthy adults with mild to moderate acne vulgaris.
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A randomized, evaluator-blind, single-center, parallel-group clinical study designed to evaluate the local tolerance of two facial cleansers containing Benzoyl Peroxide (BPO) in comparison to a commercial control in healthy adults with mild to moderate acne vulgaris.
Trial description: A randomized, evaluator-blind, single-center, parallel-group, 3-arm clinical study designed to evaluate the local tolerability of the two new Benzoyl peroxide formulations in participants with mild to moderate acne vulgaris, following twice daily application for 21±2 days.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Combined (sum of) Dermatologist skin irritation scores
Timeframe: At Visit 3 (Day 21±2)
Secondary outcomes:
Combined (sum of) Ophthalmologist irritation scores
Timeframe: At Visit 3 (Day 21±2)
Combined (sum of) participant self-assessment scores (face)
Timeframe: At Visit 3 (Day 21±2)
Combined (sum of) participant self-assessment scores (eyes)
Timeframe: At Visit 3 (Day 21±2)
Individual dermatologist scores for erythema, edema, desquamation/peeling, dryness
Timeframe: At Visit 3 (Day 21±2)
Individual ophthalmologist scores for conjunctiva
Timeframe: At Visit 3 (Day 21±2)
Individual participant self-assessment scores for face (redness, dryness, burning, itching, peeling)
Timeframe: At Visit 3 (Day 21±2)
Individual participant self-assessment scores for eyes (redness, dryness, burning, itching, stinging)
Timeframe: At Visit 3 (Day 21±2)
Individual participant product acceptability questionnaire
Timeframe: At Visit 3 (Day 21±2)
Adverse Events
Timeframe: At Visit 3 (Day 21±2)
Interventions:
Enrollment:
141
Primary completion date:
2017-09-02
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Santos-Caetano JP, Cargill MR. A Randomized Controlled Tolerability Study to Evaluate Reformulated Benzoyl Peroxide Face Washes for Acne Vulgaris. J Drugs Dermatol. 2019 Apr 1;18(4):350-356. PMID:31012563
Medical condition
Acne Vulgaris
Product
benzoyl peroxide
Collaborators
Not applicable
Study date(s)
November 2016 to February 2017
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18 - 45 Year
Accepts healthy volunteers
yes
- Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- Aged between 18 and 45 years inclusive.
- Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
- Women who are breast-feeding.
Inclusion and exclusion criteria
Inclusion criteria:
- Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- Aged between 18 and 45 years inclusive.
- Good general and mental health with, in the opinion of the investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history or upon physical examination.
- Willingness to actively participate in the study and to attend all scheduled visits.
- Participants with mild to moderate acne vulgaris, defined as a score of 2-3 using the Investigator Global Assessment (IGA) scale, Fitzpatrick photo-type I-V, dermatologist scores of ≤1 for erythema, and 0 for dryness, desquamation/peeling and edema at Baseline (i.e. at Combined Visit 1 and 2 or Visit 2 if not combined), Ophthalmologist scores of 0 for conjunctiva involvement and lacrimal intensity at Baseline (i.e. Combined Visit 1 and 2 or Visit 2 if not combined).
- Females of childbearing potential who are, in the opinion of the investigator, practicing a reliable method of contraception. Adequate contraception is defined as abstinence, oral contraceptive, either combined or progestogen alone or injectable progestogen or implants of levonorgestrel or estrogenic vaginal ring or percutaneous contraceptive patches or intrauterine device or intrauterine system or double barrier method (condom or occlusive cap [diaphragm or cervical vault caps] plus spermicidal agent [foam, gel, film, cream, suppository]) or male partner sterilization prior to the female participant's entry into the study, and this male is the sole partner for that participant.
Exclusion criteria:
- Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
- Women who are breast-feeding.
- Active skin disease in the test area, medical history of dysplastic nevi or melanoma or moles, tattoos, scars, irritated skin, facial hairs, etc. at the test area that could influence the investigation. Systemic therapy with immuno-suppressive drugs (e.g. corticosteroids) and/or antihistamines within 7 days prior to the start of the study, systemic use of over-the-counter (OTC) analgesics or anti-inflammatory drugs 24 hours prior to dosing at the first assessment visit, systemic use of tretinoin, isotretinoin or tazarotene within 1 month prior to the start of the study. One of the following illnesses that might require regular systemic medication: Insulin-dependent diabetes, cancer. One of the following illnesses if not medicated: Asthma, hypertension, medical history of abnormal response to sunlight, participants with a history of mental illness. Participants with acne conglobate, fulminans, secondary acne (drug induced acne) or any acne requiring systemic treatment. Ocular surgery within the last 12 months, ocular trauma, infection or inflammation within the last 3 months. Blepharitis, conjunctivitis, uveitis, topical ocular treatment within the last month, ocular laser within the last 3 months, Aesthetic, cosmetic or dermatological treatment in the treatment area (face) within the last month, intense sun exposure, ultraviolet (UV)-treatments or tanning salon visit within the last 2 weeks.
- Known or suspected intolerance, allergy or hypersensitivity to Benzoyl Peroxide, the study materials (or closely related compounds) or any of their stated ingredients and history of allergies to cosmetic products or medicated acne treatments.
- Participation in another clinical study (including cosmetic studies) on the face or receipt of an investigational drug within 30 days of the screening visit and previous participation in this study.
- Recent history (within the last 5 years) of alcohol or other substance abuse.
- An employee of the sponsor or the study site or members of their immediate family.
Trial location(s)
Study documents
Statistical analysis plan
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
Clinical study report
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2017-09-02
Actual study completion date
2017-09-02
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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Additional information
A Randomized Controlled Tolerability Study to Evaluate Reformulated Benzoyl Peroxide Face Washes for Acne Vulgaris
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