Acne Vulgaris
Conditions
Brief summary
Acne medications are a common source of facial dryness resulting in skin barrier damage and poor patient compliance. Retinoids and benzoyl peroxide are some of the most frequently prescribed and effective acne medications, however, dryness is an unwanted side effect. A new acne medication, 1% clascoterone, has been placed in a novel vehicle for excellent drug delivery in combination with excellent barrier properties. The barrier properties of 1% clascoterone have never been demonstrated. This study is aimed at better understanding the positive barrier effects of 1% clascoterone.
Interventions
Splitface design- Subjects applied Winlevi (clascoterone) cream 1%, twice daily to the randomized half face following cleansing, every morning and evening.
Sponsors
Sun Pharmaceutical Industries Limited
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
The Outcomes Assessor/Investigator was blinded to which side of the face received the treatment
Intervention model description
Patients were randomized to apply treatment (winlevi 1%) to one side of the face and the other side of the face remained untreated
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects who self identify as having sensitive acne prone skin. 2. Female or male subjects 18+ years of age. 3. Subjects with Fitzpatrick skin types I-VI. 4. Subject agrees not to introduce any new colored cosmetics (lipsticks, eye shadows, facial foundations, blush, powder) or skin care products during the study. 5. Subjects must be willing to use only a cleanser and sunscreen on the entire face and no other skin care products. 6. Subjects must be willing to use the Winlevi study product to designated half face. No other topical acne treatment products on the entire face for the 2 week duration of the study. 7. Subject has signed an Informed Consent Form in compliance with 21CFR Part 50: Protection of Human Subjects. 8. Subject is dependable and able to follow directions and is willing to comply with the schedule of visits. 9. Subject is in generally good physical and mental health.
Exclusion criteria
1. Any dermatological disorder, which in the investigator's opinion, may interfere with the accurate evaluation of the subject's skin characteristics, except for the conditions associated with sensitive skin. 2. Subjects who are not willing to use only the assigned study product and nothing else one randomized half face, except for cleanser and sunscreen that must remain unchanged during the study. Moisturizers or topical acne treatment products should not be used during the 2 week study period on either side of the face. 3. Subjects who do not agree to refrain from direct sun exposure during the study duration. 4. Subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study products. 5. Subjects, who are pregnant, breast feeding, or planning a pregnancy. 6. Subjects with clinically significant unstable medical disorders. 7. Subjects who are unwilling or unable to comply with the requirements of the protocol. 8. Subjects who have history of a psychological illness or condition that would interfere with their ability to understand and follow the requirements of the study. 9. Subjects who are currently participating in any other clinical study. 10. Subjects with any planned surgeries and/or invasive medical procedures during the course of the study. 11. Subjects who currently or frequently use high doses of anti-inflammatory drugs for a defined medication condition. Aspirin use should not exceed 2 tablets (650 mg) per day. 12. Subjects currently receiving any anticancer, immunosuppressive treatments/ medications (e.g., azathioprine, belimumab, cyclophosphamide, Enbrel, Imuran, Humira, mycophenolate mofetil, methotrexate, prednisone, Remicade, Stelara.), or radiation as determined by the initial paperwork. 13. Subjects with a history of immunosuppression/immune deficiency disorders (including (HIV infection or AIDS) or currently using immunosuppressive medications (e.g., azathioprine, belimumab, cyclophosphamide, Enbrel, Imuran, Humira, mycophenolate mofetil, methotrexate, prednisone, Remicade, Stelara) and/or radiation as determined by study documentation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Primary Endpoint is the Change in Corneometry Reading Between the Two Sides of the Face Treated With Winlevi Versus no Treatment. | Week 2 | The Corneometer measures skin hydration with a range of 0- 1000 MicroSiemens, where 0 is lowest and 1000 is highest hydration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in TEWL Reading Between the Two Sides of the Face Treated With Winlevi Versus no Treatment | Week 2 | The instrument measures trans epidermal water loss (abbreviated as TEWL) which ranges from minimum 0 (no trans epidermal water loss) to maximum 100 (high trans epidermal water loss) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Winlevi (Clascoterone) 1% Treated Winlevi (clascoterone) 1% cream: Split face. Blinded study treatment product to be applied to the randomized half face | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | Winlevi (Clascoterone) 1% Treated |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 50 Participants |
| Race/Ethnicity, Customized African Americans | 19 Participants |
| Race/Ethnicity, Customized Caucasians | 30 Participants |
| Race/Ethnicity, Customized Hispanic | 1 Participants |
| Sex: Female, Male Female | 38 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 50 |
| other Total, other adverse events | 1 / 50 |
| serious Total, serious adverse events | 0 / 50 |
Outcome results
Primary
The Primary Endpoint is the Change in Corneometry Reading Between the Two Sides of the Face Treated With Winlevi Versus no Treatment.
The Corneometer measures skin hydration with a range of 0- 1000 MicroSiemens, where 0 is lowest and 1000 is highest hydration
Time frame: Week 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Winlevi (Clascoterone) 1% Un-treated Side (UT) | The Primary Endpoint is the Change in Corneometry Reading Between the Two Sides of the Face Treated With Winlevi Versus no Treatment. | 131.27 microSiemens (μS) | Standard Deviation 42.92 |
| Winlevi (Clascoterone) 1% Treated Side (T) | The Primary Endpoint is the Change in Corneometry Reading Between the Two Sides of the Face Treated With Winlevi Versus no Treatment. | 113.94 microSiemens (μS) | Standard Deviation 36.61 |
p-value: <0.001t-test, 2 sided
Secondary
Change in TEWL Reading Between the Two Sides of the Face Treated With Winlevi Versus no Treatment
The instrument measures trans epidermal water loss (abbreviated as TEWL) which ranges from minimum 0 (no trans epidermal water loss) to maximum 100 (high trans epidermal water loss)
Time frame: Week 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Winlevi (Clascoterone) 1% Un-treated Side (UT) | Change in TEWL Reading Between the Two Sides of the Face Treated With Winlevi Versus no Treatment | 9.94 g/h/m² | Standard Deviation 2.59 |
| Winlevi (Clascoterone) 1% Treated Side (T) | Change in TEWL Reading Between the Two Sides of the Face Treated With Winlevi Versus no Treatment | 9.92 g/h/m² | Standard Deviation 2.88 |