Fractionated 1927-nm Non Ablative Thulium Laser in Treating Post Inflammatory Hyperpigmentation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Patients treated with laser.
- Who it may be relevant to
- Registry conditions: Healthy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy and Safety of the Fractionated 1927-nm Non Ablative Thulium Laser in Treating Post Inflammatory Hyperpigmentation in Skin Phototypes IV-VI
Overview
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.
Interventions
- Device Patients treated with laser
Patients treated with laser with topical steroid Patients treated with laser with vehicle
Primary outcome measures
- Degree of Pigmentation in all 5 subjects [Time frame: Visit 1 (Day 0) through Visit 5 (Day 112 ±5)]
Secondary outcome measures (2)
- Immunohistochemical changes in pigmentation in all 5 subjects [Time frame: Visit 2 (Day 28±5) and Visit 5 (Day 112 ±5)]
- Immunohistochemical changes in inflammation in all 5 subjects [Time frame: Visit 2 (Day 28±5) and Visit 5 (Day 112 ±5)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Henry Ford Medical Center — Detroit
Identifiers
NCT: NCT06149780 · 16268