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

Study Overview
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Device: Patients treated with laser


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fractional laser patients treated with laser<br>Laser with topical steroid and laser with vehicle. | Device: Patients treated with laser<br>* Patients treated with laser with topical steroid Patients treated with laser with vehicle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunohistochemical changes in pigmentation in all 5 subjects | Histology assess parameter including pigmentation | Visit 2 (Day 28±5) and Visit 5 (Day 112 ±5) | 
| Immunohistochemical changes in inflammation in all 5 subjects | Histology assess parameter including inflammation | Visit 2 (Day 28±5) and Visit 5 (Day 112 ±5) |