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NCT Number: NCT06149780

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

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

Recruiting

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Henry Ford Medical Center

Detroit, Michigan, 48202, United States

Location status: Recruiting

Location contact

Fanar Razoky, Bachelors

CONTACT

[email protected]

313-694-1923

Mohammad Tasneem, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patients treated with laser

Device

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Fanar Razoky, Bachelors

CONTACT

[email protected]

313-694-1923

Mohammad Tasneem, MD

CONTACT

[email protected]

313-916-2151

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Nov 29, 2023
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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