Acne Vulgaris
Conditions
Keywords
acne, irritation, objective sensory methods
Brief summary
A study to compare the skin irritation potential of two marketed gels for acne treatment, each applied to half of the face of healthy volunteers.
Detailed description
At the Baseline Visit, following satisfaction of entry criteria and screening procedures, all subjects will be applying two products to their faces, each on one side only. The side of the face receiving each product is randomly assigned. One group will use Retin-A MICRO Gel, (tretinoin) 0.04% Pump on the left side of the face and Epiduo Gel (adapalene .1% and benzoyl peroxide 2.5%), on the right side of the face daily for 3 consecutive weeks after washing with study-supplied facial wash. The other group will use the same products, but on opposite sides of the face for three consecutive weeks after washing with the same study-supplied facial wash. Subjects will return to the study center every weekday morning for evaluation and application of both study products. Applications done on the weekends, will be done at home by the subject. At each visit the subject will be scored for cutaneous treatment effects by a blinded evaluator. At baseline and at the end of each week, subjects will be photographed and have chromometer readings.
Interventions
DRUGTretinoin Facial Gel
A marketed facial gel containing Tretinoin 0.04% is applied to one side of the face daily for three weeks.
DRUGAdapalene/Benzoyl Peroxide Facial Gel
A marketed facial gel containing Adapalene .1% and Benzoyl peroxide 2.5% is applied to the other side of the face daily for three weeks
Sponsors
Bausch Health Americas, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy volunteers * Before screening, subjects (or legally authorized representative) must read and sign the IRB approved Informed Consent Form (includes HIPPA and Photo release) * Subjects must have Fitzpatrick Skin Type I, II or III, and judged by the Investigator to have healthy skin * Subject's bilateral facial skin must be clear of any confounding irritation, rashes, acne, rosacea, etc. prior to the study * Subject must be free of systemic retinoids for at least 2 months * Subject must not be using any topical retinoids, systemic antibiotics, nicotinamide or systemic steroids for 1 month prior to study start * All other topical medications to face (e.g., steroids, antimicrobials, salicylic acid and benzoyl peroxide) and cosmetics containing retinols, AHA's and bleaching agents such as hydroquinone are to be discontinued at least 2 weeks prior to study initiation * Subjects will not apply any emollients and cosmetics to the facial area 24 hours prior to study initiation * Subject must not be planning to become pregnant or nursing before entering the study and during the study period. In addition if using birth control pills, subject must be stabilized for at least 2 months. If subject is of child bearing potential, subject must be using approved method of birth control. Approved methods are birth control pills, implants, patches or spermicide with condoms.
Exclusion criteria
* Subjects who are pregnant or nursing * Subjects who have a grade 1 or more for facial erythema * Subjects who exhibit any skin condition (i.e., atopic dermatitis, seborrheic dermatitis, and psoriasis) or disease that may require concurrent therapy or may confound the evaluation of drug safety or efficacy * Subjects who have a history of hypersensitivity to any of the formulation components * Subjects who have received any experimental drug or used any experimental device 30 days prior to initiation of study therapy * Subjects who have excessive facial hair that may obstruct or hinder the evaluation of any reactions * Subjects who use any known photosensitizing agents * Subjects who presently have skin cancer or actinic keratosis on the face
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Facial Irritation and Cutaneous Effects | three weeks | Scores on a scale were recorded each weekday. The scale for Erythema and Dryness was from 0=none to 8=severe (highest possible score is calculated as 8x5daysx3weeks=120). The scale for Burning/Stinging and Itching was from 0=none to 3=severe (highest possible score was calculated as 3x5daysx3weeks=45). The scores that were accumulated through the study for each treatment were then compared. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tretinoin & Adapalene-Benzoyl Peroxide Tretinoin and Adapalene-Benzoyl Peroxide facial gels applied once daily in a split face model | 162 |
| Total | 162 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 7 |
Baseline characteristics
| Characteristic | Tretinoin & Adapalene-Benzoyl Peroxide |
|---|---|
| Age Continuous | 31 years STANDARD_DEVIATION 8.2 |
| Region of Enrollment United States | 162 participants |
| Sex: Female, Male Female | 141 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 162 | 0 / 162 |
| serious Total, serious adverse events | 0 / 162 | 0 / 162 |
Outcome results
Primary
Facial Irritation and Cutaneous Effects
Scores on a scale were recorded each weekday. The scale for Erythema and Dryness was from 0=none to 8=severe (highest possible score is calculated as 8x5daysx3weeks=120). The scale for Burning/Stinging and Itching was from 0=none to 3=severe (highest possible score was calculated as 3x5daysx3weeks=45). The scores that were accumulated through the study for each treatment were then compared.
Time frame: three weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tretinoin Facial Gel | Facial Irritation and Cutaneous Effects | Erythema | 1.5 Scores on a Scale | Standard Deviation 3.8 |
| Tretinoin Facial Gel | Facial Irritation and Cutaneous Effects | Burning/Stinging | 1.9 Scores on a Scale | Standard Deviation 4 |
| Tretinoin Facial Gel | Facial Irritation and Cutaneous Effects | Dryness | 3.1 Scores on a Scale | Standard Deviation 6.1 |
| Tretinoin Facial Gel | Facial Irritation and Cutaneous Effects | Itching | 1.0 Scores on a Scale | Standard Deviation 2.3 |
| Adapalene-Benzoyl Peroxide Facial Gel | Facial Irritation and Cutaneous Effects | Dryness | 7.8 Scores on a Scale | Standard Deviation 10.3 |
| Adapalene-Benzoyl Peroxide Facial Gel | Facial Irritation and Cutaneous Effects | Erythema | 5.4 Scores on a Scale | Standard Deviation 11.8 |
| Adapalene-Benzoyl Peroxide Facial Gel | Facial Irritation and Cutaneous Effects | Itching | 2.9 Scores on a Scale | Standard Deviation 4.4 |
| Adapalene-Benzoyl Peroxide Facial Gel | Facial Irritation and Cutaneous Effects | Burning/Stinging | 5.8 Scores on a Scale | Standard Deviation 6.5 |