A randomized investigator-blind study evaluating the efficacy and safety of 0.005% trifarotene cream versus 0.05% VAA cream in the treatment of moderate facial acne
- Conditions
- moderate acne vulgaris patientsTrifarotene, acne vulgaris, fourth-generation retinoid
- Registration Number
- TCTR20210531008
- Lead Sponsor
- Galderma Thailand
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 60
1.Male or female, 18-50 years of age
2.Participants who have been diagnosed with moderate acne at baseline visit
3.Participants must willingly give informed consent.
1.Participants who have acneiform eruption (e.g., chloracne, drug-induced acne) or other facial inflammatory skin conditions precluding the acne assessment
2.Participants who have any uncontrolled or severe diseases or any medical or surgical conditions, such as polycystic ovarian syndrome, may interfere with the interpretation or compliance with the protocol
3.Participants who expose to excessive ultraviolet radiation within one month before the baseline visit or plan to expose intense UV during this trial
4.Participants who are unwilling to refrain from use of prohibited medication including topical (such as topical benzoyl peroxide, azelaic acid, or topical antibiotics) and systemic (such as systemic antibiotics, oral antiandrogens, or oral isotretinoin) medications affecting acne conditions during this trial
5.A pregnant woman or nursing or unable to use non-hormonal birth control
6.Participants who have a history of study drug allergy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the percentage of subjects who achieve investigator global assessment (IGA) score of 0 and 1 and have at least a 2-grade improvement. baseline, week 1, 2, 4, 8, 12 IGA score,inflammatory acne counts baseline, week 1, 2, 4, 8, 12 inflammatory acne counts,non-inflammatory acne count baseline, week 1, 2, 4, 8, 12 non-inflammatory acne count
- Secondary Outcome Measures
Name Time Method safety and skin tolerability week 1, 2, 4, 8, 12 safety and skin tolerability,patient satisfaction week 1, 2, 4, 8, 12 satisfaction score (0-10)