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

NCT ID: NCT06149780

Last Updated: 2025-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-15

Study Completion Date

2026-08-30

Brief Summary

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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

Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fractional laser patients treated with laser

Laser with topical steroid and laser with vehicle.

Group Type EXPERIMENTAL

Patients treated with laser

Intervention Type DEVICE

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

Interventions

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Patients treated with laser

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Henry Ford Health System

OTHER

Sponsor Role lead

Responsible Party

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Tasneem Mohammad

Staff Physician, Department of Dermatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Henry Ford Medical Center

Detroit, Michigan, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Fanar Razoky, Bachelors

Role: CONTACT

313-694-1923

Mohammad Tasneem, MD

Role: CONTACT

313-916-2151

Facility Contacts

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Fanar Razoky, Bachelors

Role: primary

313-694-1923

Other Identifiers

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16268

Identifier Type: -

Identifier Source: org_study_id

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