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

June 19, 2025 updated by: Tasneem Mohammad, Henry Ford Health System

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Medical Center
        • Contact:
        • Principal Investigator:
          • Mohammad Tasneem, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Visit 1 (Day 0) through Visit 5 (Day 112 ±5)
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
Time Frame: Visit 2 (Day 28±5) and Visit 5 (Day 112 ±5)
Histology assess parameter including pigmentation
Visit 2 (Day 28±5) and Visit 5 (Day 112 ±5)
Immunohistochemical changes in inflammation in all 5 subjects
Time Frame: Visit 2 (Day 28±5) and Visit 5 (Day 112 ±5)
Histology assess parameter including inflammation
Visit 2 (Day 28±5) and Visit 5 (Day 112 ±5)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henry Ford Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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