FaciaI Skin Rejuvenation with a Solid State Dual Wavelength 589/1319 nm Laser: A Split Face, Single-blinded, Randomized Controlled TriaI

Phase 3

• Conditions: The patients who had concern of uneven skin tone, wrinkle, large pore, discoloration or dullness, and requirement of facial skin rejuvenation; photoaging; facial skin rejuvenation; non-ablative laser

• Registration Number: TCTR20221215005
• Lead Sponsor: Division of Dermatology, Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-15
• Study Completion: 2023-06-22
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: nknown
• Sex: Female
• Target Recruitment: 12

Inclusion Criteria

1. Healthy females aged 18 years old and above
3. The patients who had concern of uneven skin tone, wrinkle, large pore, discoloration or dullness, and requirement of facial skin rejuvenation
4. Patients who willing to participate in the study and follow the protocol with signing the consent form

Exclusion Criteria

1. Patients who have severe systemic disease
2. Patients who have active acne lesions, facial skin infection or other facial skin disorder for example solar lentigo, melasma
3. Patients who had apply any types of topical medication at face past 1 month
4. Patients who had chemical peeling past 3 months
5. Patients who had been injected dermal filler, botulinum toxin or any other laser or rejuvenation procedures affect facial skin past 6 months
6. Patients who use oral isotretinoin past 6 months
7. Pregnant and lactating patients
8. Patients who disincline for participating in the study
9. Patients who withdraw from the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
skin texture, skin tone, wrinkle, spot, pore size, pigmentation, and sebum secretion at 2,4,6,10,18 weeks after the beginning of intervention The modified Fitzpatrick wrinkle scale, 10-point clinical assessment score, 10-point satisfaction rating scale, UV reflectance photography using VISIA system, Antera 3D camera

Secondary Outcome Measures

Name	Time	Method
histological change of in vivo human tissue, adverse effect pain score: 0,2,4,6 weeks after the beginning of intervention. skin biopsy: at 10 and 18 weeks after the beginning of intervention. adverse event report: every patient's visit Histological analysis by skin biopsy, pain score, adverse event report