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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

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.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20210531008
Enrollment
60
Registered
2021-05-31
Start date
2021-08-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

moderate acne vulgaris patients Trifarotene, acne vulgaris, fourth-generation retinoid

Interventions

0.005%Trifarotene,0.05% VAA cream
Experimental Drug,Active Comparator Drug

Sponsors

Galderma Thailand
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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)

Countries

Thailand

Contacts

Public ContactChanat Kumtornrut

Faculty of Medicine, Chulalongkorn university

chanat_1@yahoo.com66814594965

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026