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Procedure

Laser Treatment for Hyperpigmentation

N/A

Recruiting

Research Sponsored by Henry Ford Health System

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient to have discontinued all oral medications used to treat pigmentary abnormalities and all topical medications, except for sunscreen, used to treat pigmentary abnormalities on the buttocks one month prior to treatment

Patient age 18 and older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up visit 2 (day 28±5) and visit 5 (day 112 ±5)

Awards & highlights

Study Summary

This trial studies if a laser treatment plus topical steroid can reduce post-inflammatory hyperpigmentation. 3 monthly sessions are tested with histological and molecular changes compared to untreated skin.

Who is the study for?

This trial is for adults over 18 with darker skin types (IV-VI) who have post-inflammatory hyperpigmentation. Participants must stop all pigment-related treatments except sunscreen on the buttocks one month before starting and be able to understand study risks and consent.Check my eligibility

What is being tested?

The trial tests if three monthly sessions of a fractionated 1927-nm non-ablative thulium laser can reduce hyperpigmentation. It also examines the effectiveness of clobetasol propionate ointment after treatment, as well as histological and molecular changes in treated versus untreated skin.See study design

What are the potential side effects?

Potential side effects may include temporary redness, swelling, or discomfort at the laser site. Rarely, there could be changes in skin color or texture. The topical steroid might cause thinning of the skin or other local reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I stopped all oral and topical treatments for skin color changes on my buttocks, except sunscreen, a month ago.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ visit 2 (day 28±5) and visit 5 (day 112 ±5)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~visit 2 (day 28±5) and visit 5 (day 112 ±5)

This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 2 (day 28±5) and visit 5 (day 112 ±5) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Degree of Pigmentation in all 5 subjects

Secondary outcome measures

Immunohistochemical changes in inflammation in all 5 subjects

Immunohistochemical changes in pigmentation in all 5 subjects

Trial Design

1Treatment groups

Experimental Treatment

Group I: Fractional laser patients treated with laserExperimental Treatment1 Intervention

Laser with topical steroid and laser with vehicle.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Henry Ford Health SystemLead Sponsor

300 Previous Clinical Trials

2,099,867 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 enrollment still available for this research endeavor?

"According to the details on clinicaltrials.gov, this experimental trial is currently recruiting participants with an initial posting of December 1st 2023 and most recent updated noted as November 20th 2023."

Answered by AI

What is the current capacity of this experiment?

"Affirmative. The information on clinicaltrials.gov states that this investigation is still recruiting participants, having been initially posted in December 1st 2023 and subsequently updatedNovember 20th of the same year. This research requires 15 individuals from a single medical centre to take part."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Fractionated 1927-nm Non Ablative Thulium Laser in Treating Post Inflammatory Hyperpigmentation

Tasneem Mohammad 2023. "Fractionated 1927-nm Non Ablative Thulium Laser in Treating Post Inflammatory Hyperpigmentation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06149780.

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