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

NCT06149780 | Recruiting DMC FDA Device

• 1 other identifier: 16268
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

To study the effect of fractionated 1927-nm non ablative thulium laser in reduction of post inflammatory hyperpigmentation (PIH) using a validated and reproducible model for studying PIH.

• Determine if there is aa reduction in PIH in patients treated with three (3) monthly sessions of fractionated 1927-nm non ablative thulium laser
• Determine if there is efficacy of post-procedure clobetasol propionate 0.05% ointment in the management of PIH
• Determine the histological and molecular changes that occur with laser and laser plus topical steroid treatment compared to untreated skin

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Degree of Pigmentation in all 5 subjects

  Measured clinical with IGA objectively with colometry

  Visit 1 (Day 0) through Visit 5 (Day 112 ±5)

Secondary Outcomes (2)

• Immunohistochemical changes in pigmentation in all 5 subjects

  Visit 2 (Day 28±5) and Visit 5 (Day 112 ±5)

• Immunohistochemical changes in inflammation in all 5 subjects

  Visit 2 (Day 28±5) and Visit 5 (Day 112 ±5)

Study Arms (1)

Fractional laser patients treated with laser

EXPERIMENTAL

Laser with topical steroid and laser with vehicle.

Device: Patients treated with laser

Interventions

Patients treated with laser DEVICE

Patients treated with laser with topical steroid Patients treated with laser with vehicle

Fractional laser patients treated with laser

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient age 18 and older
• Patient with skin phototypes IV-VI
• Patient able to understand requirements of the study and risks involved
• Patient able to sign a consent form
• 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

You may not qualify if:

• A patient who has skin dyspigmentation, birth marks, tattoos, or other skin findings at baseline on either buttock that may obscure study results
• A patient who is lactating, pregnant, or planning to become pregnant

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Medical Center

Detroit, Michigan, 48202, United States

RECRUITING

MeSH Terms

Interventions

Lasers

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Central Study Contacts

Fanar Razoky, Bachelors

CONTACT

313-694-1923; frazoky1@hfhs.org

Mohammad Tasneem, MD

CONTACT

313-916-2151; TMOHAMM2@hfhs.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician, Department of Dermatology

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: November 29, 2023
• Study Start: November 15, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: June 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)