Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-30 @ 7:01 AM
Study NCT ID:
NCT05656833
Status:
UNKNOWN
Last Update Posted:
2022-12-19
First Post:
2022-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination Topical Cysteamine and Fractional 1927nm Low-Powered Diode Laser for Treatment of Facial Melasma
Sponsor:
UnionDerm
Organization:
Study Overview
Official Title:
Combination Topical Cysteamine and Fractional 1927nm Low-Powered Diode Laser
Status:
UNKNOWN
Status Verified Date:
2022-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: