Trichloroacetic Acid (TCA) Combined With Microdermabrasion in Treatment of Melasma

NCT04823520 | Unknown Phase 4

• 1 other identifier: TCA & MDA to treat melasma
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.To detect the efficacy and safety of combined TCA and MDA in treating melasma.
2. 2.To compare the efficacy and safety of using different TCA concentrations (15% \& 20%) alone and in combination with MDA in treatment of melasma.

Conditions

Melasma

Keywords

TCA; Chemical peeling; Microdermabrasion; Trichloroacetic acid; MELASMA; MDA

Outcome Measures

Primary Outcomes (1)

• "EFFICACY of combined Trichloroacetic acid (15% or 20 %) and microdermabrasion in treating melasma "

  To detect the efficacy of combined Trichloroacetic acid (15% or 20 %) and microdermabrasion in treating melasma. Clinical photographs: Front, right and left views of face of each patient will be photographed at baseline, every two weeks and one month after the last session with and high resolution digital camera in natural light.

  3 months

Study Arms (2)

Group 15% concentration

ACTIVE COMPARATOR

30 patients MDA will be done to one half of the face then TCA 15% will be applied to the whole face.

Drug: TCA

Group 20 % concentration

ACTIVE COMPARATOR

30 patients will receive MDA to one side of the face , TCA 20% will then be applied to the whole face.

Drug: TCA

Interventions

TCA DRUG

All patients will receive 6 sessions at 2 weeks intervals,the half face which will recieve MDA and TCA,MDA will be done before appling TCA.

Also known as: MIcrodermabrasion (MDA)

Group 15% concentration; Group 20 % concentration

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults of 18 years and above with bilateral melasma
• Clinical diagnosis of melasma.
• Mental capacity to give informed consent.

You may not qualify if:

• Pregnant or nursing women
• Current use of hormonal birth control medication or any hormonal therapy
• History of laser or dermabrasion to the face within 9 months of study enrollment
• Patients with poor wound healing, recurrent herpes simplex and current skin infection (facial warts, molluscum contagiosum) and history of hypertropic scar/keloids
• Photosensitivity.
• Patients with unrealistic expectations All the included patients will be subjected to detailed history taking,dermatological examination and Wood's light examination to estimate the depth (epidermal, dermal or mixed) of melasma.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (10)

• Bandyopadhyay D. Topical treatment of melasma. Indian J Dermatol. 2009;54(4):303-9. doi: 10.4103/0019-5154.57602.

  PMID: 20101327 BACKGROUND

• Sanchez NP, Pathak MA, Sato S, Fitzpatrick TB, Sanchez JL, Mihm MC Jr. Melasma: a clinical, light microscopic, ultrastructural, and immunofluorescence study. J Am Acad Dermatol. 1981 Jun;4(6):698-710. doi: 10.1016/s0190-9622(81)70071-9.

  PMID: 6787100 BACKGROUND

• Guinot C, Cheffai S, Latreille J, Dhaoui MA, Youssef S, Jaber K, Nageotte O, Doss N. Aggravating factors for melasma: a prospective study in 197 Tunisian patients. J Eur Acad Dermatol Venereol. 2010 Sep;24(9):1060-9. doi: 10.1111/j.1468-3083.2010.03592.x. Epub 2010 Feb 25.

  PMID: 20202051 BACKGROUND

• Tamega Ade A, Miot LD, Bonfietti C, Gige TC, Marques ME, Miot HA. Clinical patterns and epidemiological characteristics of facial melasma in Brazilian women. J Eur Acad Dermatol Venereol. 2013 Feb;27(2):151-6. doi: 10.1111/j.1468-3083.2011.04430.x. Epub 2012 Jan 3.

  PMID: 22212073 BACKGROUND

• Mandry Pagan R, Sanchez JL. Mandibular melasma. P R Health Sci J. 2000 Sep;19(3):231-4.

  PMID: 11076368 BACKGROUND

• Ritter CG, Fiss DV, Borges da Costa JA, de Carvalho RR, Bauermann G, Cestari TF. Extra-facial melasma: clinical, histopathological, and immunohistochemical case-control study. J Eur Acad Dermatol Venereol. 2013 Sep;27(9):1088-94. doi: 10.1111/j.1468-3083.2012.04655.x. Epub 2012 Jul 24.

  PMID: 22827850 BACKGROUND

• Lapeere H, Boone B, Schepper SD.(2018) : Hypomelanosis and hypermelanosis. In: Wolff K,Goldsmith LA, Katz SI, editors.Dermatology in general medicine. 7th ed. New York: McGraw Hill. p. 635

  BACKGROUND

• Lebwohl M, Heymann W, Berth-Jones J. Treatment of skin disease: Comprehensive therapeutic strategies. St. Louis, MO: Mosby; 2002.

  BACKGROUND

• Molinar VE, Taylor SC, Pandya AG. What's new in objective assessment and treatment of facial hyperpigmentation? Dermatol Clin. 2014 Apr;32(2):123-35. doi: 10.1016/j.det.2013.12.008.

  PMID: 24679999 BACKGROUND

• Jutley GS, Rajaratnam R, Halpern J, Salim A, Emmett C. Systematic review of randomized controlled trials on interventions for melasma: an abridged Cochrane review. J Am Acad Dermatol. 2014 Feb;70(2):369-73. doi: 10.1016/j.jaad.2013.07.044.

  PMID: 24438951 BACKGROUND

MeSH Terms

Conditions

Melanosis

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Hatem Ze mohamed, professor

CONTACT

+201003420217; zedanhzma@aun.edu.eg

Radwa Mo bakr, Dr

CONTACT

+201119988115; Radwabakr2011@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Model Details: (Group 1): 30 patients MDA will be done to one half of the face then TCA 15% will be applied to the whole face. (Group 2): 30 patients will receive MDA to one side of the face , TCA 20% will then be applied to the whole face.

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: March 30, 2021
• Study Start: April 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: September 30, 2022
• Last Updated: March 30, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share