Microneedling for Acquired Hypomelanosis

Study Overview
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Brief Summary
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Acquired hypomelanosis is a type of cutaneous melanocytopenic hypomelanosis, denoting the lightening of the skin due to a reduction in the number of epidermal and/or follicular melanocytes secondary to physical agents,post-inflammatory, and iatrogenic (steroids). Derma roller is the basic device of microneedling , performs superficial, controlled puncturing of the skin by rolling with miniature fine needles and used as a collagen induction therapy and a transdermal delivery system for therapeutic drugs and vaccines. This minute trauma to the skin that activates regenerative mechanisms and wound healing by releasing growth factors. The release of cytokines and deposition of hemosiderin from dermal bleeding induce the activation of melanocyte and stimulate skin pigmentation plus transdermal traveling of melanocyte

Detailed Description
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The aim of this study to evaluate the efficacy and safety of microneedling as a treatment model for patients with acquired hypomelanosis. Patients with an acquired hypomelanosis from outpatient clinic, department of dermatology, Cairo university,n=20. including: ▪Patients, both genders and older than 18 years with localized acquired hypomelanosis Excluding: Congenital and hereditary hypomelanosis. Vitiligo Pregnancy and lactation. Patients with a history of any autoimmune disease. Patients with a history of keloid formation. Patient on systemic steroids, retinoids, immunosuppressant or anticoagulant therapy. Methodology in details: An informed written consent will be obtained from the patient or his legal guardian if he is younger than 21years old. For every patient detailed history will focus on the onset, course, duration of hypomelanosis, the type of insult, previous treatments, systemic illness and drug history. The examination will describe the anatomical site, size, degree of skin lightening, skin texture and presence or absence of hair in the affected area. The area to be treated will be specified and split into two halves then randomized into one of both arms: treatment or no treatment. One session of microneedling will be performed on the treatment arm by using dermaroller 1.5 mm long. The microneedling will be done from the edge of the normal skin towards the center of the hypopigmented lesion in all the directions (horizontal, vertical. diagonal). Patients will be then monitored for three months for signs of repigmentation. Patient's improvement will be objectively assessed monthly for repigmentation using patient's and physician's scales. Possible Risk: Pain, transient bleeding, erythema, mild edema and infection at the site of microneedling. Failure of treatment is also a possibility. Primary outcomes: Efficacy of microneedling for acquired hypomelanosis after 3 months. Secondary outcome: Safety as defined by the occurrence of adverse events during, shortly after the procedure (2weeks), and after 3 months. Sample size(number of patients included):20 patients Source of funding: self funding

Official Title
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Microneedling for Acquired Hypomelanosis : A Randomized Controlled Trial

Conditions
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Acquired Hypomelanosis

Intervention / Treatment
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* Procedure: Microneedling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Localized acquired hypomelanosis secondary to any insult, post-inflammatory or iatrogenic of no more than 2 years duration, affecting any anatomical site except genitalia, of any size larger than 3 cm in diameter. Patients older than 18 years old, consenting to go through the microneedling procedure. Both genders. Exclusion criteria: Congenital and hereditary hypomelanosis. Vitiligo Pregnancy and lactation. Patients with history of any autoimmune disease. Patients with history of keloids formation. Patient on systemic steroids, retinoids, immunosuppressant or anticoagulant therapy.

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The area to be treated will be specified and split into two halves then randomized using sealed envelope into one of both arms: treatment or no treatment. One session of microneedling using derma roller 1.5 mm will be done.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment<br>microneedling. | Procedure: Microneedling<br>* One session of microneedling will be performed by using dermaroller 1.5 mm. The microneedling done from the edge of the normal skin towards the center of the hypopigmented lesion in all the directions (horizontal, vertical. diagonal).<br>|
| No Intervention: No treatment<br>No treatment will be done to these hypopigmented lesions | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of microneedling for acquired hypomelanosis assessed by skin mapping for peripheral tanning. | drawing the lesion's surface area through transparent stencil paper | 3 months post treatment | 
| Efficacy of microneedling for acquired hypomelanosis assessed by visual analogue scale for surface tanning | using hue skin tone color scale | 3 months post treatment | 
| Efficacy of microneedling for acquired hypomelanosis assessed by vitiligo extent score for a target area for marginal and perifollicular repigmentation. | The repigmentation assessed by percentage value range from 0- 100% where the 100 % means full repigmentation, the value is a result of an equation where the estimated percentage of marginal repigmentation add to ( remaining area (%) plus estimated percent of perifollicular pigmentation in the remaining area(%) divided by 100) | 3 months post treatment | 
| Efficacy of microneedling for acquired hypomelanosis assessed by the patient's satisfaction score | 3-point scale (not satisfied, moderately satisfied, extremely satisfied). | 3 months post treatment | 
| Efficacy of microneedling for acquired hypomelanosis assessed by patient global percent of his own improvement(0-100%). | the patient evaluation to lesion by percentage value for repigmentation ranged from 0- 100% which represent full repigmentation. | 3 months post treatment | 
| Efficacy of microneedling for acquired hypomelanosis assessed by mean physician's global assessment for percent of improvement (0-100%). | One unblinded and 2 blinded investigators assessed the global improvement through photographs of the lesions before and after 3 months of therapy. The lesions were photographed on a black background using a single reflex camera with standardized settings (ambient light, same position, and distance from the patient). | 3 moonths post treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of microneedling adverse events | Safety as defined by occurrence of pain, bleeding, local infection, skin flaking, and scarring during, shortly after the procedure (2weeks), and at the end of the study. | Day 1 to 14 and after 3 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microneedling, Dermaroller, acquired hypomelanosis, skin pigmentation, hypopigmentation, patient satisfaction, leukoderma