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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06149780
• Other study ID #: 16268
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2023
• Est. completion date: August 30, 2026

Study information

• Verified date: February 2024
• Source: Henry Ford Health System
• Contact: Fanar Razoky, Bachelors
• Phone: 313-694-1923
• Email: frazoky1[@]hfhs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: August 30, 2026
• Est. primary completion date: August 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Hyperpigmentation

Intervention

Device:
• Patients treated with laser
Patients treated with laser with topical steroid Patients treated with laser with vehicle

Locations

Country	Name	City	State
United States	Henry Ford Medical Center	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Immunohistochemical changes in pigmentation in all 5 subjects	Histology assess parameter including pigmentation	Visit 2 (Day 28±5) and Visit 5 (Day 112 ±5)
Secondary	Immunohistochemical changes in inflammation in all 5 subjects	Histology assess parameter including inflammation	Visit 2 (Day 28±5) and Visit 5 (Day 112 ±5)