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

Efficacy and Safety of the Fractionated 1927-nm Non Ablative Thulium Laser in Treating Post Inflammatory Hyperpigmentation in Skin Phototypes IV-VI

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

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Device: Patients treated with laser

Detailed Description

The design of the study consists of a total of six visits including one initial screening visit within 107-127 days depending on the scheduling of your screening and subsequent visits. Assessments such as visual examination, photography, Investigatory Global Assessment (IGA) of pigmentation and erythema; Colorimetry; and Diffuse Reflectance Spectroscopy of the intended treatment area will be conducted at Visits 1-5. Optional biopsies will be taken at various time points.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fanar Razoky, Bachelors; Phone Number: 313-694-1923; Email: Frazoky1@hfhs.org
• Study Contact Backup: Name: Mohammad Tasneem, MD; Phone Number: 313-916-2151; Email: TMOHAMM2@hfhs.org

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Recruiting
      • Henry Ford Medical Center
      • Contact: Fanar Razoky, Bachelors; Phone Number: 313-694-1923; Email: Frazoky1@hfhs.org
      • Principal Investigator: Mohammad Tasneem, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fractional laser patients treated with laser; Laser with topical steroid and laser with vehicle.	Device: Patients treated with laser; Patients treated with laser with topical steroid Patients treated with laser with vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunohistochemical changes in pigmentation in all 5 subjects	Histology assess parameter including pigmentation	Visit 2 (Day 28±5) and Visit 5 (Day 112 ±5)
Immunohistochemical changes in inflammation in all 5 subjects	Histology assess parameter including inflammation	Visit 2 (Day 28±5) and Visit 5 (Day 112 ±5)

Collaborators and Investigators

• Sponsor: Henry Ford Health System

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 30, 2026

Study Registration Dates

• First Submitted: October 24, 2023
• First Submitted That Met QC Criteria: November 20, 2023
• First Posted (Actual): November 29, 2023

Study Record Updates

• Last Update Posted (Estimated): June 25, 2025
• Last Update Submitted That Met QC Criteria: June 19, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hyperpigmentation
• Other Study ID Numbers: 16268

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No