NCT05656833

Combination Topical Cysteamine and Fractional 1927nm Low-Powered Diode Laser for Treatment of Facial Melasma

Combination Topical Cysteamine and Fractional 1927nm Low-Powered Diode Laser

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: UnionDerm · Academic / Other
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Accepted

Summary

The primary objective of our study is to determine the efficacy of combined topical cysteamine cream with a 1927 diode non-ablative laser (Clear + Brilliant Permea®; Solta Medical, Inc.), compared to topical cysteamine (Cyspera) alone in the treatment of melasma. The main questions it aims to answer are * If melasma treatment with topical cysteamine cream is more effective when used with the Clear \& Brilliant® Permea laser * The safety \& efficacy of melasma treatment in various skin types using the Clear \& Brilliantt® Permea laser in combination with topical cysteamine. Participants will * Come into our office for an initial screening appointment to determine if participant is eligible for the study * Come in for 3 laser treatments, 4 weeks apart, on 1 side of the face * Use the study provided Cyspera topical cream every day on the entire face for the 12 weeks on the study. Researchers will compare the side of the participants face not treated with laser to the side of the face treated with laser. The participants will be using Cyspera on both sides of their face.

Conditions

• Melasma

Interventions

Type	Name	Description
DEVICE	Fractional 1927nm Low-Powered Diode Laser	Clear \& Brilliant Permea® Laser used on the side of the face randomized to receive laser
OTHER	Topical Cysteamine	Topical Cysteamine cream will be used on the entire face.

Timeline

• Start date: 2022-10-28
• Primary completion: 2023-04-01
• Completion: 2023-07-01
• First posted: 2022-12-19
• Last updated: 2022-12-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study