Patients with moderate acne vulgaris Acne vulgaris, acne, Trifarotene, Aklief, Tretinoin
Conditions
Interventions
Participants will apply 0.005% Trifarotene cream once daily to the randomly assigned side of the face for the treatment of moderate acne vulgaris over a 12-weeks study period. ,Participants will appl
Experimental Drug,Active Comparator Drug
0.005% Trifarotene cream,0.05% Tretinoin cream
Sponsors
Salinee Rojhirunsakool
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or older with no underlying disease 2. Presence of moderate facial acne vulgaris, defined as an Investigator's Global Assessment(IGA score) of 3 characterized by : - Inflammatory lesions >= 20 lesions, and - Non-inflammatory lesions >= 25 lesions, and/or - Presence of nodular acne, with no more than 1 nodule. 3. Willingness to participate in the study voluntarily, with written informed consent provided by signing the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Participants who have used topical medications prior to study enrollment within 4 weeks, including : - Topical agents anti-inflammatory effects, such as topical corticosteroids of any type. - Topical acne treatments, including benzoyl peroxide, topical retinoids, topical antibiotics (e.g. clindamycin, erythromycin), azelaic acid, or similar agents. 2. Participants who have received systemic medications prior to study initiation, including : - Systemic agents with anti-inflammatory effects or that may effect acne treatment within 4 weeks prior to study, such as oral corticosteriods, oral zinc supplementation, or systemic antibiotics. - Systemic retinoids within 3 months prior to study initiation, such as isotretinoin. 3. Pregnant or breastfeeding women, including those who not using contraception or planning to pregnancy during the study period. 4. Presence of allergic contact dermatitis, eczema, open wound, or active infection on the facial area. 5. History of allergy to retinoids or retinoic acid derivatives. 6. Participants who are unable to comply with treatment or follow-up requirements during the study period. 7. History of allergy to any component of the products used in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total acne lesion count baseline, week 2,4,6,8, and 12 after treatment manual counting by blinded investigator | — |
Secondary
| Measure | Time frame |
|---|---|
| Inflammatory lesion count baseline, week 2,4,6,8, and 12 after treatment manual counting by blinded dermatologist,Noninflammatory lesion count baseline, week 2,4,6,8, and 12 after treatment manual counting by blinded dermatologist,Improvement of acne by Investigator's Global Assessment (IGA) score baseline, week 2,4,6,8, and 12 after treatment IGA score assessment by blinded dermatologist,Improvement of post inflammatory hyperpigmentation baseline, week 2,4,6,8, and 12 after treatment PAPHI scale assessment by blinded dermatologist,side effect week 2,4,6,8, and 12 after treatment assessment by blinded dermatologist and patient report,patient satisfaction week 12 (end of study) visual analog scale by patient | — |
Countries
Thailand
Contacts
Public ContactSalinee Rojhirunsakool
Department of Dermatology, Faculty of Medicine, Srinakharinwirot University
Outcome results
None listed