Recruiting

Thulium Laser

Sponsor:

Henry Ford Health System

Code:

NCT06149780

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Patients treated with laser

Study Details

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

Study ID

NCT06149780

Start date

Nov 15, 2023

Status verified date

Mar, 2025

Completion date

Aug 30, 2026

Anticipated

Primary completion date

Aug 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Fractional laser patients treated with laser

Laser with topical steroid and laser with vehicle.

Interventions

Patients treated with laser

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

Primary outcome measure

  • Degree of Pigmentation in all 5 subjects [ Time Frame: Visit 1 (Day 0) through Visit 5 (Day 112 ±5) ]

Central Contacts and Locations

Central contacts

Fanar Razoky, Bachelors

313-694-1923frazoky1@hfhs.org

Mohammad Tasneem, MD

313-916-2151TMOHAMM2@hfhs.org

Locations

Henry Ford Medical Center

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Fanar Razoky, Bachelors

313-694-1923Frazoky1@hfhs.org

Principal Investigator:

Mohammad Tasneem, MD

More Information

Sponsor

Henry Ford Health System

Last update posted

Jun 25, 2025

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Henry Ford Health System on 2025-06-25.