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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

Study Summary

This trial will compare the effects of topical cysteamine cream with laser treatment in treating melasma. Participants will receive laser treatments and use topical cysteamine cream for 12 weeks.

Eligible Conditions

Melasma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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.

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an age limit to eligibility for this medical trial?

"Individuals must be of legal age and no older than 74 years old to take part in the trial, as these parameters were set for inclusion criteria."

Answered by AI

Is enrollment for this investigation still open?

"According to the data provided by clinicaltrials.gov, this medical experiment is currently seeking participants. The trial was originally published on October 28th 2022 and recently revised on December 15th 2022."

Answered by AI

What is the upper bound of participants taking part in this research endeavor?

"Affirmative. Per the details on clinicaltrials.gov, this medical trial is presently looking for volunteers to take part in it - with its initial posting date being October 28th 2022 and most recent update taking place December 15th 2022. The research requires 20 patients from a single site."

Answered by AI

Would I be eligible to join this clinical examination?

"This clinical trial is welcoming 20 volunteers aged 18 to 74 who have melasma. To be eligible for this study, individuals must possess a Skin Type I-VI and understand the Informed Consent form; moreover, they need to commit to all subsequent follow-ups required by the research team."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "Combination Topical Cysteamine and Fractional 1927nm Low-Powered Diode Laser for Treatment of Facial Melasma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05656833.

All > Melasma