Silymarin Cream Versus Combined Silymarin Cream and Microneedling in Treatment of Melasma

NCT05099601 | Unknown Phase 4

• 1 other identifier: MSM
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Melasma is an acquired pigmentary disorder, occurring most commonly on the face. It is more prevalent in females and darker skin types. Melasma is mainly a clinical diagnosis consisting of symmetric reticulated hypermelanosis in three predominant facial patterns: centrofacial, malar, and mandibular. Melasma, though benign, can be extremely psychologically distressing and has been shown to have a significant impact on quality of life, social and emotional wellbeing. Multiple factors are implicated in the pathogenesis of melasma; however, the definite underlying mechanisms are not yet completely established. Ultraviolet exposure is one of the leading etiological factors, besides genetic and hormonal factors.

Conditions

Melasma

Outcome Measures

Primary Outcomes (1)

• compare between the efficacy of topical silymarin alone and its combination with microneedling in treatment of melasma.

  Scoring of the patients according to modified Melasma Area and Severity Index (mMASI) score before and after treatment.

  3 months

Study Arms (1)

Silymarin alone versus silymarin and microneedling

EXPERIMENTAL

There will be one group of patients. Each side of the patients' face will be randomly allocated to either topical silymarin 0.7% and microneedling or topical silymarin 0.7% alone.

Combination Product: Silymarin; Procedure: Microneedling

Interventions

Silymarin COMBINATION_PRODUCT

The patients will use topical silymarin 0.7% cream on the face twice daily(home use).

Silymarin alone versus silymarin and microneedling

Microneedling PROCEDURE

Patients will be subjected to microneedling sessions on one side of the face. Three consecutive sessions, 4 weeks apart (0, 4, 8 weeks), will be performed by dermapen. Sessions will be done by well trained physician.

Silymarin alone versus silymarin and microneedling

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 18-50 years old.
• Pattern of melasma: Bilateral symmetrical facial melasma of any pattern.
• Fitzpatrick skin phototypes: Types III, IV and V

You may not qualify if:

• Pregnancy and lactation.
• Patients taking oral contraceptive pills, hormonal replacement therapy or treatment for chronic illness at the time of the study or during the past 6 months.
• Coexistance of diseases associated with hyperpigmentation such as Addison disease.
• Scarring and keloid tendency, active skin infections as active HSV.
• Previous history of post inflammatory hyperpigmentation.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (14)

• Balkrishnan R, McMichael AJ, Camacho FT, Saltzberg F, Housman TS, Grummer S, Feldman SR, Chren MM. Development and validation of a health-related quality of life instrument for women with melasma. Br J Dermatol. 2003 Sep;149(3):572-7. doi: 10.1046/j.1365-2133.2003.05419.x.

  PMID: 14510991 BACKGROUND

• Choo SJ, Ryoo IJ, Kim YH, Xu GH, Kim WG, Kim KH, Moon SJ, Son ED, Bae K, Yoo ID. Silymarin inhibits melanin synthesis in melanocyte cells. J Pharm Pharmacol. 2009 May;61(5):663-7. doi: 10.1211/jpp/61.05.0016.

  PMID: 19406006 BACKGROUND

• Cohen BE, Elbuluk N. Microneedling in skin of color: A review of uses and efficacy. J Am Acad Dermatol. 2016 Feb;74(2):348-55. doi: 10.1016/j.jaad.2015.09.024.

  PMID: 26549251 BACKGROUND

• Handel AC, Miot LD, Miot HA. Melasma: a clinical and epidemiological review. An Bras Dermatol. 2014 Sep-Oct;89(5):771-82. doi: 10.1590/abd1806-4841.20143063.

  PMID: 25184917 BACKGROUND

• 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.

  PMID: 27755171 BACKGROUND

• Kimbrough-Green CK, Griffiths CE, Finkel LJ, Hamilton TA, Bulengo-Ransby SM, Ellis CN, Voorhees JJ. Topical retinoic acid (tretinoin) for melasma in black patients. A vehicle-controlled clinical trial. Arch Dermatol. 1994 Jun;130(6):727-33.

  PMID: 8002642 BACKGROUND

• Kren V, Walterova D. Silybin and silymarin--new effects and applications. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2005 Jun;149(1):29-41. doi: 10.5507/bp.2005.002.

  PMID: 16170386 BACKGROUND

• Nofal A, Ibrahim AM, Nofal E, Gamal N, Osman S. Topical silymarin versus hydroquinone in the treatment of melasma: A comparative study. J Cosmet Dermatol. 2019 Feb;18(1):263-270. doi: 10.1111/jocd.12769. Epub 2018 Aug 26.

  PMID: 30146802 BACKGROUND

• Pandya AG, Hynan LS, Bhore R, Riley FC, Guevara IL, Grimes P, Nordlund JJ, Rendon M, Taylor S, Gottschalk RW, Agim NG, Ortonne JP. Reliability assessment and validation of the Melasma Area and Severity Index (MASI) and a new modified MASI scoring method. J Am Acad Dermatol. 2011 Jan;64(1):78-83, 83.e1-2. doi: 10.1016/j.jaad.2009.10.051. Epub 2010 Apr 15.

  PMID: 20398960 BACKGROUND

• Rigopoulos D, Gregoriou S, Katsambas A. Hyperpigmentation and melasma. J Cosmet Dermatol. 2007 Sep;6(3):195-202. doi: 10.1111/j.1473-2165.2007.00321.x.

  PMID: 17760699 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

• Tran JM, Chan AW (2012) Quick diagnosis: melasma. University of Toronto Med J 89: 143-145.

  BACKGROUND

• Vaid M, Katiyar SK. Molecular mechanisms of inhibition of photocarcinogenesis by silymarin, a phytochemical from milk thistle (Silybum marianum L. Gaertn.) (Review). Int J Oncol. 2010 May;36(5):1053-60. doi: 10.3892/ijo_00000586.

  PMID: 20372777 BACKGROUND

• Wu DC, Fitzpatrick RE, Goldman MP. Confetti-like Sparing: A Diagnostic Clinical Feature of Melasma. J Clin Aesthet Dermatol. 2016 Feb;9(2):48-57.

  PMID: 27047632 BACKGROUND

MeSH Terms

Conditions

Melanosis

Interventions

Silymarin; Percutaneous Collagen Induction

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Flavonolignans; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Punctures; Rehabilitation

Central Study Contacts

Sahar A Ismail, Professor

CONTACT

+201008899446; Saharsotohy@yahoo.com

Rofaida R Shehata, PHD

CONTACT

+201006897580; rofaida.refaat@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: Each side of the patients' face will be randomly allocated to either topical silymarin 0.7% and microneedling or topical silymarin 0.7% alone.

Study Record Dates

• First Submitted: October 2, 2021
• First Posted: October 29, 2021
• Study Start: May 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: October 29, 2021

Record last verified: 2021-10