Silymarin Cream Versus Combined Silymarin Cream and Microneedling in Treatment of Melasma
NCT ID: NCT05099601
Last Updated: 2021-10-29
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
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UNKNOWN
PHASE4
30 participants
INTERVENTIONAL
2022-05-31
2022-12-31
Brief Summary
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Detailed Description
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Silymarin (SM) is a standardized extract from Silybum marianum seeds, is traditionally used as a hepatoprotective agent for its potent regenerative properties. Lately, SM is utilized in dermatological and cosmetic preparations for its antioxidant effect, anti-inflammatory and immunomodulatory properties.
Silibinin, the main component of silymarin, has been found to have antioxidant properties. It decreases the hazardous effects of solar ultraviolet radiation and significantly prevents melanin production in a dose-dependent manner without effect on cell viability.
Skin microneedling, or percutaneous collagen induction by needles, is a minimally invasive procedure that uses short fine needles to puncture the skin and stimulates fibroblast proliferation, release of growth factors and collagen production.
Long-term improvement of melasma after microneedling was reported , however, the exact mechanism that promotes skin lightening is not known.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Silymarin alone versus silymarin and microneedling
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.
Silymarin
The patients will use topical silymarin 0.7% cream on the face twice daily(home use).
Microneedling
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.
Interventions
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Silymarin
The patients will use topical silymarin 0.7% cream on the face twice daily(home use).
Microneedling
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.
Eligibility Criteria
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Inclusion Criteria
* Pattern of melasma: Bilateral symmetrical facial melasma of any pattern.
* Fitzpatrick skin phototypes: Types III, IV and V
Exclusion Criteria
* 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.
18 Years
50 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Dina Abd El-nasser Attay
principal investigator
Central Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Tran JM, Chan AW (2012) Quick diagnosis: melasma. University of Toronto Med J 89: 143-145.
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.
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.
Other Identifiers
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MSM
Identifier Type: -
Identifier Source: org_study_id