Acne Vulgaris Acne Vulgaris Trifarotene Adapalene Retinoids Double-Blind Method Randomized Controlled Trial
Conditions
Interventions
Participants will apply trifarotene 0.005% cream topically to the assigned side of the face once daily in the evening for the duration of the study period, according to the study protocol.,Participant
Active Comparator Drug,Active Comparator Drug
Trifarotene 0.005% cream,Adapalene 0.1% gel
Sponsors
Institute of Dermatology
Eligibility
Sex/Gender
All
Age
18 Years to 35 Years
Inclusion criteria
Inclusion criteria: 1. Male or female subjects aged from 18 to 35 years. 2. Diagnosed with mild to moderate acne vulgaris with IGA score 2 or 3. 3. Having at least 10 inflammatory acne lesions on one side of the face or at least 20 total acne lesions on one side of the face. 4. Difference in inflammatory lesion counts between both sides of the face not more than 30 percent. 5. Generally healthy with no dermatologic or medical conditions that may interfere with study assessments. 6. Female subjects of childbearing potential must have a negative urine pregnancy test at baseline and agree to use effective contraception throughout the study and for at least 1 month after study completion. 7. Able and willing to comply with study procedures and provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. History of hypersensitivity to retinoids trifarotene adapalene or study medication components. 2. Presence of facial skin diseases that may interfere with evaluation such as rosacea eczema or active skin infection. 3. Use of oral isotretinoin within 6 months before screening. 4. Use of systemic antibiotics or systemic corticosteroids within 4 weeks before screening. 5. Use of topical retinoids benzoyl peroxide azelaic acid topical antibiotics or keratolytic agents within 4 weeks before screening. 6. Undergoing facial dermatologic procedures within 4 weeks before screening. 7. Receiving laser IPL or light based facial treatment within 12 weeks before screening. 8. Pregnant or breastfeeding women or women unwilling to use effective contraception. 9. Use of medications known to cause photosensitivity. 10. Participation in another interventional clinical study within 30 days before enrollment. 11. Any significant medical condition that may affect subject safety or study compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acne lesion count and IGA score Baseline and follow up visits Transepidermal water loss erythema sebum hydration patient reported tolerability and dermatology life quality index | — |
Secondary
| Measure | Time frame |
|---|---|
| Skin barrier function and tolerability Baseline and follow up visits Transepidermal water loss erythema sebum hydration patient reported tolerability and dermatology life quality index | — |
Countries
Thailand
Contacts
Public ContactLisa Suwannaketkarn
Institute of Dermatology, Thailand
Outcome results
None listed