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Completed

NCT Number: NCT04419350

Microneedling for Acquired Hypomelanosis

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, 35855, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Microneedling

Procedure

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).

Primary outcomes

  1. 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

  2. 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. 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)

  4. 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).

  5. 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.

  6. 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).

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Microneedling for Acquired Hypomelanosis : A Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 5, 2020
Registry last updated
Jun 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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