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Fractional 1927nm Low-Powered Diode Laser combined with Topical Cysteamine for Melasma
N/A
Recruiting
Research Sponsored by UnionDerm
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing if a combination of a special cream and a laser treatment works better for treating dark patches on the face compared to using the cream alone. It focuses on people with melasma, a condition that causes these dark patches. The cream lightens the skin, and the laser helps it work better. Combination therapies have been observed to yield greater improvements in melasma.
Eligible Conditions
- Melasma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 alone in the treatment of melasma.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Fractional 1927nm Low-Powered Diode Laser combined with Topical CysteamineActive Control2 Interventions
One side of the face of participants will be randomized to receive fractional 1927nm Low-Powered Diode Laser in combination with topical cysteamine. There are 3 total treatments with the laser, in combination with using the topical cysteamine cream every day for the duration of the study (12 weeks)
Group II: Topical Cysteamine AloneActive Control1 Intervention
The other side of the face that is not randomized to receive laser treatment will be subject to treatment with the topical cysteamine cream alone. Participants will use the topical cysteamine cream every day for the duration of the study (12 weeks).
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Who is running the clinical trial?
UnionDermLead Sponsor
Solta MedicalIndustry Sponsor
7 Previous Clinical Trials
189 Total Patients Enrolled
Skin of Color SocietyUNKNOWN
1 Previous Clinical Trials
11 Total Patients Enrolled
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