Microneedling for Acquired Hypomelanosis

Cairo University (CU)

Status

Completed

Conditions

Acquired Hypomelanosis

Treatments

Procedure: Microneedling

Study type

Interventional

Funder types

Other

Identifiers

NCT04419350

MN for acquired hypomelanosis

Details and patient eligibility

About

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

Full 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

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.