Adapalene/Clindamycin Gel in Vietnamese Acne Patients
Official title: A Prospective, Observational, Phase IV, Open-Label, Multicenter, Single-Arm Study to Characterize the Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Fixed-Dose Combination Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Run by Ir Innovate Research Private Limited · NCT07918001 · Data updated 2026-11-12
This study tests how safe and tolerable and how well Klenzit-C works when used in routine care by Vietnamese patients aged 12 and up with mild to moderate acne.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 12 Years to 99 Years |
| Sex | All |
| Enrollment | 225 (estimated) |
| Sponsor | Ir Innovate Research Private Limited Industry-sponsored |
| Locations | 3 sites (Hanoi and 2 other locations) |
| Status | Recruiting |
| Started | February 25, 2026 |
| Main results expected | February 28, 2027 |
| Study ends | May 10, 2027 |
| Registry record updated | November 5, 2026 |
| Trial ID | NCT07918001 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are Vietnamese patients aged 12 years or older with mild to moderate acne vulgaris who are already prescribed Klenzit-C as part of routine care.
✕Probably not a fit
Patients with severe acne or those unlikely to respond to topical therapy may not experience benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 4, open-label, multicenter, prospective study in Vietnam evaluating adapalene 0.1%/clindamycin 1% gel used as part of standard practice. About 360 participants will apply the gel once daily for 12 weeks, with visits at baseline and Weeks 2, 4, 8, and 12. The main focus is safety and tolerability, including local skin reactions, with additional observations on changes in inflammatory and non-inflammatory lesions. The study describes real-world use of the product and its clinical effectiveness in routine dermatology care.
Why it matters
Potential benefit: If successful, patients may experience clearer skin and fewer acne-related symptoms with a well-tolerated, single-product regimen.
How similar studies have gone: Previous studies combining retinoids with topical antibiotics have shown greater efficacy than monotherapy in acne treatment.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients aged 12 years or more, of either gender diagnosed with acne vulgaris defined by: 1. 10 to 50 inflammatory lesions (papules, pustules, and nodules) 2. 5 to 50 non-inflammatory lesions (open and closed comedones) 3. IGA score of mild (2) or moderate (3) 2. Patients who will refrain from use of any other topical medications, medicated cleansers, medicated moisturizers, or skincare products containing active ingredients such as azelaic acid, salicylic acid, niacinamide, glycolic acid, benzoyl peroxide, ethanol, resorcinol, alpha-hydroxy acids (AHAs), tretinoin, retinol, isotretinoin, ingredients derived from lime, menthol, camphor, citrus oils, nor have excessive exposure to sunlight throughout the study period. 3. Literate patients willing to give consent to participate in the study. Exclusion Criteria: 1. Severe systemic disease as assessed by the Investigator that might interfere with the conduct of the study or the interpretation of the results. 2. Patients with concomitant facial dermatoses (e.g., Atopic dermatitis, Rosacea, Discoid lupus erythematosus, Sensitive skin syndrome, Irritant contact dermatitis, etc.) 3. Sunburn on the face. 4. Pregnant and lactating females. 5. Concurrent participation in another clinical study or use of other topical medications. 6. Refusal to participation expressed by patient.
Where it's running
-
Ho Chi Minh City Hospital of Dermatology and Venereology
Hanoi, Vietnam Recruiting -
Le Van Thinh Hospital
Ho Chi Minh City, Vietnam Recruiting -
Bach Mai Hospital
Hanoi, Vietnam Not yet recruiting
Study contacts
- Study coordinator: Dr. Nguyen Thi Phan Thuy, Doctor
- Email: devesh.kumar@innovate-research.com
- Phone: +91-9971169602
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.