Microneedling for Acquired Hypomelanosis

NCT04419350 | Completed

• 1 other identifier: MN for acquired hypomelanosis
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Acquired Hypomelanosis

Keywords

Microneedling; Dermaroller; acquired hypomelanosis; skin pigmentation; hypopigmentation; patient satisfaction; leukoderma

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• Incidence of microneedling adverse events

  Day 1 to 14 and after 3 months.

Study Arms (2)

treatment

EXPERIMENTAL

microneedling.

Procedure: Microneedling

No treatment

NO INTERVENTION

No treatment will be done to these hypopigmented lesions

Interventions

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).

treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, 35855, Egypt

Location

Related Publications (17)

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• Elhoshy K, Ibrahim J, Hafez V. Microneedling in Localized Acquired Hypomelanosis: A Randomized Controlled Trial. Dermatol Surg. 2025 Mar 1;51(3):257-262. doi: 10.1097/DSS.0000000000004447. Epub 2024 Nov 25.

  PMID: 39584682 DERIVED

MeSH Terms

Conditions

Pigmentation Disorders; Hypopigmentation; Patient Satisfaction; Vitiligo

Interventions

Percutaneous Collagen Induction

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Punctures; Rehabilitation

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dermatology resident,Principal investigator-Cairo university.

Model Details: * 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.

Study Record Dates

• First Submitted: May 23, 2020
• First Posted: June 5, 2020
• Study Start: September 15, 2019
• Primary Completion: April 1, 2020
• Study Completion: May 1, 2020
• Last Updated: June 9, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)