Efficacy of Microneedle Fractional Radiofrequency combined with Topical Insulin for the treatment of facial atrophic acne scar: A split-face, double-blinded, randomized, placebo-controlled trial
Phase 3
Recruiting
- Conditions
- Acne scarAcne scar, topical insulin, microneedle fractional radiofrequency
- Registration Number
- TCTR20211203003
- Lead Sponsor
- Division of Dermatology, Ramathibodi Hospital, Mahidol University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
1. No serious underlying conditions
2. Symmetrical facial acne scar
3. Agree to participate and signed informed consent form
Exclusion Criteria
1. History of infection at facial area
2. Uncontrolled acne vulgaris
3. History of keloid scar or hypertrophic scar
4. Immunocompromised host
5. History of dermatological malignancy
6. History of herpes infection
7. History of using vitamin A derivatives within 3 months
8. History of laser treatment within 3 months
9. History of chemical peeling within 3 months
10. Underlying diabetes mellitus, connective tissue diseases, and photodermatoses
11. Allergic to insulin and topical anesthesic drugs
12. Pregnancy or lactation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Scar volume Every visit Percentage changes in scar volume
- Secondary Outcome Measures
Name Time Method Subjective assessment by two blinded dermatologists Every visit ECCA Grading scale,Patient's evaluation of the improvement score 3 months after the end of the intervention Visual analogue scale,Patient's satisfaction evaluation 3 months after the end of the intervention Visual analogue scale,Side effects 0, 1,2,3,4 and 6 months after procedure Investigator's evaluation