Clinical trial NCT04419350: Microneedling for Acquired Hypomelanosis
Official title: Microneedling for Acquired Hypomelanosis : A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acquired Hypomelanosis
Keywords: Microneedling
Dermaroller
acquired hypomelanosis
skin pigmentation
hypopigmentation
patient satisfaction
leukoderma
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-06-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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: 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

Eligibility criteria: 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.

Primary outcomes:
measure: Efficacy of microneedling for acquired hypomelanosis assessed by skin mapping for peripheral tanning.
timeFrame: 3 months post treatment
measure: Efficacy of microneedling for acquired hypomelanosis assessed by visual analogue scale for surface tanning
timeFrame: 3 months post treatment
measure: Efficacy of microneedling for acquired hypomelanosis assessed by vitiligo extent score for a target area for marginal and perifollicular repigmentation.
timeFrame: 3 months post treatment
measure: Efficacy of microneedling for acquired hypomelanosis assessed by the patient's satisfaction score
timeFrame: 3 months post treatment
measure: Efficacy of microneedling for acquired hypomelanosis assessed by patient global percent of his own improvement(0-100%).
timeFrame: 3 months post treatment
measure: Efficacy of microneedling for acquired hypomelanosis assessed by mean physician's global assessment for percent of improvement (0-100%).
timeFrame: 3 moonths post treatment.
Secondary outcomes:
measure: Incidence of microneedling adverse events
timeFrame: Day 1 to 14 and after 3 months.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Professor of Dermatology,Cairo University
name: Khaled H El-Hoshy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate Professor of Dermatology, Cairo University
name: Vanessa G Hafez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dermatology Resident
name: Julbahar M Ibrahim, M.B.,B.CH
role: PRINCIPAL_INVESTIGATOR
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