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 on their faces, each on half face. The side of face receiving each product is randomly assigned. One group will use tretinoin facial gel on the left side and adapalene facial gel on the right side of the face daily for two 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 two consecutive weeks after washing with the same study-supplied facial wash. Subjects will return to the study center every weekday morning for evaluation and for the morning application of both study products. Study personnel will monitor application on the weekdays. There will be a daily clinical evaluation of skin irritation by a blinded dermatologist and by subjects. At baseline and at the end of each week subjects will be photographed and have chromometer readings.
Interventions
DRUGAdapalene Gel
adapalene gel 0.3% topically applied daily in a split-face model for two weeks
DRUGTretinoin Gel
Tretinoin 0.1% topically applied daily in a split face model for two weeks
Sponsors
Bausch Health Americas, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 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). * Subject 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 study start. * 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 listed in Appendix 1. * 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 |
|---|---|---|
| Assessment of Facial Irritation and Cutaneous Effects | cumulative daily weekday scores for two weeks | Cumulative daily weekday scores for two weeks on Expert Grader Assessments: Dryness (0-8, none-deep)and Erythema (0-8, none-severe) and Self-Assessments: Burning/Stinging (0-3, none-severe) and Itching (0-3, none-severe) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Combined Arms All subjects received treatment with both gels in a split-face model | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
Baseline characteristics
| Characteristic | Combined Arms |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants |
| Age Continuous | 30.36 years STANDARD_DEVIATION 6.6 |
| Region of Enrollment United States | 25 participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Assessment of Facial Irritation and Cutaneous Effects
Cumulative daily weekday scores for two weeks on Expert Grader Assessments: Dryness (0-8, none-deep)and Erythema (0-8, none-severe) and Self-Assessments: Burning/Stinging (0-3, none-severe) and Itching (0-3, none-severe)
Time frame: cumulative daily weekday scores for two weeks
Population: One panelist terminated treatment on Day 2. Her scores were carried over and the analysis was based on Intention to Treat (ITT).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adapalene | Assessment of Facial Irritation and Cutaneous Effects | Erythema (cumulative scores on a scale) | 4.8 Ordinal data treated as interval | Standard Deviation 4.2 |
| Adapalene | Assessment of Facial Irritation and Cutaneous Effects | Dryness (cumulative scores on a scale) | 8.8 Ordinal data treated as interval | Standard Deviation 6.2 |
| Adapalene | Assessment of Facial Irritation and Cutaneous Effects | Burning/Stinging (cumulative scores on a scale) | 2.0 Ordinal data treated as interval | Standard Deviation 2.6 |
| Adapalene | Assessment of Facial Irritation and Cutaneous Effects | Itching (cumulative scores on a scale) | 1.4 Ordinal data treated as interval | Standard Deviation 1.5 |
| Tretinoin | Assessment of Facial Irritation and Cutaneous Effects | Itching (cumulative scores on a scale) | 0.8 Ordinal data treated as interval | Standard Deviation 1 |
| Tretinoin | Assessment of Facial Irritation and Cutaneous Effects | Erythema (cumulative scores on a scale) | 3.9 Ordinal data treated as interval | Standard Deviation 5.4 |
| Tretinoin | Assessment of Facial Irritation and Cutaneous Effects | Burning/Stinging (cumulative scores on a scale) | 2.4 Ordinal data treated as interval | Standard Deviation 5.9 |
| Tretinoin | Assessment of Facial Irritation and Cutaneous Effects | Dryness (cumulative scores on a scale) | 6.7 Ordinal data treated as interval | Standard Deviation 8.5 |