Microneedling for Acquired Hypomelanosis

June 4, 2020 updated by: Julbahar Ibrahim, Cairo University

Microneedling for Acquired Hypomelanosis : A Randomized Controlled Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 35855
        • Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: treatment
microneedling.
Procedure: Microneedling
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).
No Intervention: No treatment
No treatment will be done to these hypopigmented lesions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of microneedling for acquired hypomelanosis assessed by skin mapping for peripheral tanning.
Time Frame: 3 months post treatment
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
Time Frame: 3 months post treatment
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.
Time Frame: 3 months post treatment
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
Time Frame: 3 months post treatment
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%).
Time Frame: 3 months post treatment
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%).
Time Frame: 3 moonths post treatment.
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
Time Frame: Day 1 to 14 and after 3 months.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Khaled H El-Hoshy, MD, Professor of Dermatology,Cairo University
  • Principal Investigator: Vanessa G Hafez, MD, Associate Professor of Dermatology, Cairo University
  • Principal Investigator: Julbahar M Ibrahim, M.B.,B.CH, Dermatology Resident

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2019

Primary Completion (Actual)

April 1, 2020

Study Completion (Actual)

May 1, 2020

Study Registration Dates

First Submitted

May 23, 2020

First Submitted That Met QC Criteria

June 3, 2020

First Posted (Actual)

June 5, 2020

Study Record Updates

Last Update Posted (Actual)

June 9, 2020

Last Update Submitted That Met QC Criteria

June 4, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MN for acquired hypomelanosis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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