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

Not Applicable

Recruiting

• Conditions: Healthy
• Interventions: Device: Patients treated with laser

• Registration Number: NCT06149780
• Lead Sponsor: Henry Ford Health System

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

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 Timeline

• Study First Submitted: 2023-10-24
• Study Start: 2023-11-15
• Study First Submitted QC: 2023-11-20
• Study First Posted: 2023-11-29
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-28
• Primary Completion: 2026-08-01
• Study Completion: 2026-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fractional laser patients treated with laser	Patients treated with laser	Laser with topical steroid and laser with vehicle.

Primary Outcome Measures

Name	Time	Method
Degree of Pigmentation in all 5 subjects	Visit 1 (Day 0) through Visit 5 (Day 112 ±5)	Measured clinical with IGA objectively with colometry

Secondary Outcome Measures

Name	Time	Method
Immunohistochemical changes in pigmentation in all 5 subjects	Visit 2 (Day 28±5) and Visit 5 (Day 112 ±5)	Histology assess parameter including pigmentation
Immunohistochemical changes in inflammation in all 5 subjects	Visit 2 (Day 28±5) and Visit 5 (Day 112 ±5)	Histology assess parameter including inflammation

Trial Locations

Locations (1)

Henry Ford Medical Center; 🇺🇸 Detroit, Michigan, United States