Different Dermatological Approaches the Treatment of Melasma

NCT03923062 | Unknown Phase 4

• 1 other identifier: DDATM
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

To compare the efficacy and safety of cryopeeling (using Liquid Nitrogen) and tranexemic acid (cyclokapron) versus chemical peeling (using TCA 20%) in treatment of melasma.

Conditions

Melasma

Outcome Measures

Primary Outcomes (3)

• melasma area and severity index (MASI)

  Clinical evaluation of melasma severity will be done by melasma area severity index (MASI) every session and at the end of treatment. No response, no improvement. * Mild response, \<25% improvement. * Moderate response, 25% to \< 50% improvement. * Good response, 50% to \< 75% improvement. * Very good response, \>75% improvement.

  baseline

• photo of the patient

  photo of the patient before and after treatment

  baseline

• Biopsy

  A punch biopsy will be taken from affected area for histipathological examination

  baseline

Study Arms (4)

G I A (right side): will be treated by chemical peeling

EXPERIMENTAL

right sideof patient's face will be treated by chemical peeling( Trichloroacetic acid 20% concentration).

Device: chemicalpeeling

G I B(left side):will be treated by cryopeeling

EXPERIMENTAL

left side of the patient's face will be treated by cryopeeling using Liquid Nitrogen.

Device: cryopeeling

G II A (right side): will be treated by chemical peeling

EXPERIMENTAL

right sideof patient's face will be treated by chemical peeling( Trichloroacetic acid 20% concentration).

Device: chemicalpeeling

G II B (left side):will be treated by tranexemic acid

EXPERIMENTAL

left side of patient's face will be treated by tranexemic acid(cyclokapron)

Combination Product: microneedling

Interventions

chemicalpeeling DEVICE

Cleansing and degreasing the face with alcohol . * The patients must be sitting at an angle of 45. * A 2 × 2 cm cotton gauze will be used to apply TCA 20%. * We will apply the acid from the midline to the right side of the forehead and under the right eye, covering the right cheek and perioral area. * We then will wait for a few minutes and will observe the frost developing. * The patient will be then allowed to wash her face.

Also known as: chemical peeling using Trichloroacetic acid 20%

G I A (right side): will be treated by chemical peeling; G II A (right side): will be treated by chemical peeling

cryopeeling DEVICE

Cryopeeling will be performed by spraying the freezing substance(Liquid Nitrogen) on the face at 1-2cm distance and moving along the affected area until freezing appear.

Also known as: cryopeeling using Liquid Nitrogen

G I B(left side):will be treated by cryopeeling

microneedling COMBINATION_PRODUCT

Tranexamic acid will be used in aconcentration of 4mg/ml ,1ml will be used fo half of the face. * After gentle cleansing, topical analgesic cream will be applied over the area to be treated. * The microneedles will be used, the skin will be stretched and microneedling will be carried out in vertical, horizontal, and both diagonal directions for about four to five times. Tranexamic acid, 0.5 to 1 ml (4 mg/mL), will be applied over this area, and the procedure will be repeated four to five times in the above-said directions

Also known as: microneedling using tranxemic acid

G II B (left side):will be treated by tranexemic acid

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects presented with melasma.
• Age 20-40 years old.
• Melasma persisting for more than 6 months that has failed to respond to conventional treatment with hydroquinone or other topical lightening agents.

You may not qualify if:

• History of photosensitivity, keloids, hypertrophic scarring and post- inflammatory hyperpigmentation.
• Pregnancy and lactation.
• Subjects with local inflammatory skin disorder or active herpes infection at the site of procedure.
• Subjects with history of medical diseases which contraindicate cryosurgery such as; cold intolerance, cold urticaria, Raynaud's disease and history of allergic reactions to cryosurgery.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (10)

• Kim EH, Kim YC, Lee ES, Kang HY. The vascular characteristics of melasma. J Dermatol Sci. 2007 May;46(2):111-6. doi: 10.1016/j.jdermsci.2007.01.009. Epub 2007 Mar 23.

  PMID: 17363223 BACKGROUND

• Hexsel D, Rodrigues TC, Dal'Forno T, Zechmeister-Prado D, Lima MM. Melasma and pregnancy in southern Brazil. J Eur Acad Dermatol Venereol. 2009 Mar;23(3):367-8. doi: 10.1111/j.1468-3083.2008.02885.x. Epub 2008 Jul 7. No abstract available.

  PMID: 18631207 BACKGROUND

• Sheth VM, Pandya AG. Melasma: a comprehensive update: part I. J Am Acad Dermatol. 2011 Oct;65(4):689-697. doi: 10.1016/j.jaad.2010.12.046.

  PMID: 21920241 BACKGROUND

• Moin A, Jabery Z, Fallah N. Prevalence and awareness of melasma during pregnancy. Int J Dermatol. 2006 Mar;45(3):285-8. doi: 10.1111/j.1365-4632.2004.02470.x.

  PMID: 16533230 BACKGROUND

• Sheth VM, Pandya AG. Melasma: a comprehensive update: part II. J Am Acad Dermatol. 2011 Oct;65(4):699-714. doi: 10.1016/j.jaad.2011.06.001.

  PMID: 21920242 BACKGROUND

• Sarkar R, Bansal S, Garg VK. Chemical peels for melasma in dark-skinned patients. J Cutan Aesthet Surg. 2012 Oct;5(4):247-53. doi: 10.4103/0974-2077.104912.

  PMID: 23378706 BACKGROUND

• Monheit GD, Chastain MA. Chemical peels. Facial Plast Surg Clin North Am. 2001 May;9(2):239-55, viii.

  PMID: 11457690 BACKGROUND

• Perper M, Eber AE, Fayne R, Verne SH, Magno RJ, Cervantes J, ALharbi M, ALOmair I, Alfuraih A, Nouri K. Tranexamic Acid in the Treatment of Melasma: A Review of the Literature. Am J Clin Dermatol. 2017 Jun;18(3):373-381. doi: 10.1007/s40257-017-0263-3.

  PMID: 28283893 BACKGROUND

• Na JI, Choi SY, Yang SH, Choi HR, Kang HY, Park KC. Effect of tranexamic acid on melasma: a clinical trial with histological evaluation. J Eur Acad Dermatol Venereol. 2013 Aug;27(8):1035-9. doi: 10.1111/j.1468-3083.2012.04464.x. Epub 2012 Feb 13.

  PMID: 22329442 BACKGROUND

• Sharma YK, Gupta A. Some Other Serendipitous Discoveries in Dermatology. Indian J Dermatol. 2016 Jan-Feb;61(1):95-6. doi: 10.4103/0019-5154.174045. No abstract available.

  PMID: 26955108 BACKGROUND

MeSH Terms

Conditions

Melanosis

Interventions

Percutaneous Collagen Induction

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Shimaa Hafez, M.B.B.CH

CONTACT

01013881659; shimaahafez75@gmail.com

Doaa Samir, Ph.D

CONTACT

01143387171; doaasamir1@Yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: April 22, 2019
• Study Start: February 1, 2020
• Primary Completion: October 1, 2020
• Study Completion: December 1, 2020
• Last Updated: January 13, 2020

Record last verified: 2020-01