Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
20 participants
INTERVENTIONAL
2019-09-15
2020-05-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of Efficacy of Microneedling and Topical Methotrexate Versus Microneedling and Topical 5-flourouracil in Treatment of Vitillgo Patients
NCT05467839
Treatment of Acral Vitiligo : Narrowband Ultraviolet-B and Microneedling With and Without Platelet Rich Plasma
NCT03155698
Punch Minigraft Versus Transverse Needling or Combination of Both in Treatment of Non-Segmental Vitiligo
NCT03872804
Microneedle and Trichloroaceticacid in Treatment of Melasma
NCT03472235
Combined Effect of Acitretin and Narrow Band Ultraviolet B on Vitiligo Repigmentation
NCT04245319
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Patients with an acquired hypomelanosis from outpatient clinic, department of dermatology, Cairo university,n=20. including:
â–ªPatients, 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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
* One session of microneedling using derma roller 1.5 mm will be done.
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
treatment
microneedling.
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 treatment
No treatment will be done to these hypopigmented lesions
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients older than 18 years old, consenting to go through the microneedling procedure.
* Both genders.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cairo University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Julbahar Ibrahim
Dermatology resident,Principal investigator-Cairo university.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Khaled H El-Hoshy, MD
Role: PRINCIPAL_INVESTIGATOR
Professor of Dermatology,Cairo University
Vanessa G Hafez, MD
Role: PRINCIPAL_INVESTIGATOR
Associate Professor of Dermatology, Cairo University
Julbahar M Ibrahim, M.B.,B.CH
Role: PRINCIPAL_INVESTIGATOR
Dermatology Resident
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cairo University
Cairo, , Egypt
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Zeitlin RE. Long-term psychosocial sequelae of paediatric burns. Burns. 1997 Sep;23(6):467-72. doi: 10.1016/s0305-4179(97)00045-4.
Tyack ZF, Pegg S, Ziviani J. Postburn dyspigmentation: its assessment, management, and relationship to scarring--a review of the literature. J Burn Care Rehabil. 1997 Sep-Oct;18(5):435-40. doi: 10.1097/00004630-199709000-00012.
Sperry K. Tattoos and tattooing. Part I: History and methodology. Am J Forensic Med Pathol. 1991 Dec;12(4):313-9. doi: 10.1097/00000433-199112000-00008.
Singh A, Yadav S. Microneedling: Advances and widening horizons. Indian Dermatol Online J. 2016 Jul-Aug;7(4):244-54. doi: 10.4103/2229-5178.185468.
Siadat AH, Rezaei R, Asilian A, Abtahi-Naeini B, Rakhshanpour M, Raei M, Hosseini SM. Repigmentation of Hypopigmented Scars Using Combination of Fractionated Carbon Dioxide Laser with Topical Latanoprost Vs. Fractionated Carbon Dioxide Laser Alone. Indian J Dermatol. 2015 Jul-Aug;60(4):364-8. doi: 10.4103/0019-5154.160481.
Kahn AM, Cohen MJ. Treatment for depigmentation following burn injuries. Burns. 1996 Nov;22(7):552-4. doi: 10.1016/0305-4179(96)88885-1.
Imokawa G. Autocrine and paracrine regulation of melanocytes in human skin and in pigmentary disorders. Pigment Cell Res. 2004 Apr;17(2):96-110. doi: 10.1111/j.1600-0749.2003.00126.x.
Hou A, Cohen B, Haimovic A, Elbuluk N. Microneedling: A Comprehensive Review. Dermatol Surg. 2017 Mar;43(3):321-339. doi: 10.1097/DSS.0000000000000924.
Glaich AS, Rahman Z, Goldberg LH, Friedman PM. Fractional resurfacing for the treatment of hypopigmented scars: a pilot study. Dermatol Surg. 2007 Mar;33(3):289-94; discussion 293-4. doi: 10.1111/j.1524-4725.2007.33058.x.
Cho S, Zheng Z, Park YK, Roh MR. The 308-nm excimer laser: a promising device for the treatment of childhood vitiligo. Photodermatol Photoimmunol Photomed. 2011 Feb;27(1):24-9. doi: 10.1111/j.1600-0781.2010.00558.x.
Chadwick S, Heath R, Shah M. Abnormal pigmentation within cutaneous scars: A complication of wound healing. Indian J Plast Surg. 2012 May;45(2):403-11. doi: 10.4103/0970-0358.101328.
Busch KH, Bender R, Walezko N, Aziz H, Altintas MA, Aust MC. Combination of medical needling and non-cultured autologous skin cell transplantation (ReNovaCell) for repigmentation of hypopigmented burn scars. Burns. 2016 Nov;42(7):1556-1566. doi: 10.1016/j.burns.2016.04.009. Epub 2016 May 4.
Busch KH, Bender R, Walezko N, Aziz H, Altintas MA, Aust MC. Combination of medical needling and non-cultured autologous skin cell transplantation (renovacell) for repigmentation of hypopigmented burn scars in children and young people. Ann Burns Fire Disasters. 2016 Jun 30;29(2):116-122.
Aust MC, Fernandes D, Kolokythas P, Kaplan HM, Vogt PM. Percutaneous collagen induction therapy: an alternative treatment for scars, wrinkles, and skin laxity. Plast Reconstr Surg. 2008 Apr;121(4):1421-1429. doi: 10.1097/01.prs.0000304612.72899.02.
Alexiades-Armenakas MR, Bernstein LJ, Friedman PM, Geronemus RG. The safety and efficacy of the 308-nm excimer laser for pigment correction of hypopigmented scars and striae alba. Arch Dermatol. 2004 Aug;140(8):955-60. doi: 10.1001/archderm.140.8.955.
Acikel C, Ulkur E, Guler MM. Treatment of burn scar depigmentation by carbon dioxide laser-assisted dermabrasion and thin skin grafting. Plast Reconstr Surg. 2000 May;105(6):1973-8. doi: 10.1097/00006534-200005000-00009.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MN for acquired hypomelanosis
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.