Microneedling for Acquired Hypomelanosis

Acquired Hypomelanosis Clinical Trial

Official title:

Microneedling for Acquired Hypomelanosis : A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04419350
• Other study ID #: MN for acquired hypomelanosis
• Status: Completed
• Phase: N/A
• Start date: September 15, 2019
• Est. completion date: May 1, 2020

Study information

• Verified date: June 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Hypomelanosis
• Hypopigmentation

Intervention

Procedure:
• 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).

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (16)

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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. — View Citation

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):1421-9. doi: 10.1097/01.prs.0000304612.72899.02. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Imokawa G. Autocrine and paracrine regulation of melanocytes in human skin and in pigmentary disorders. Pigment Cell Res. 2004 Apr;17(2):96-110. Review. — View Citation

Kahn AM, Cohen MJ. Treatment for depigmentation following burn injuries. Burns. 1996 Nov;22(7):552-4. — View Citation

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. — View Citation

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. Review. — View Citation

Sperry K. Tattoos and tattooing. Part I: History and methodology. Am J Forensic Med Pathol. 1991 Dec;12(4):313-9. — View Citation

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. Review. — View Citation

Zeitlin RE. Long-term psychosocial sequelae of paediatric burns. Burns. 1997 Sep;23(6):467-72. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Efficacy of microneedling for acquired hypomelanosis assessed by visual analogue scale for surface tanning	using hue skin tone color scale	3 months post treatment
Primary	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
Primary	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
Primary	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
Primary	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	Incidence of microneedling adverse events	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.	Day 1 to 14 and after 3 months.