Silymarin Cream Versus Combined Silymarin Cream and Microneedling in Treatment of Melasma
Primary Purpose
Melasma
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Silymarin
Microneedling
Sponsored by
About this trial
This is an interventional treatment trial for Melasma
Eligibility Criteria
Inclusion Criteria:
- Age: 18-50 years old.
- Pattern of melasma: Bilateral symmetrical facial melasma of any pattern.
- Fitzpatrick skin phototypes: Types III, IV and V
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Silymarin alone versus silymarin and microneedling
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05099601
Brief Title
Silymarin Cream Versus Combined Silymarin Cream and Microneedling in Treatment of Melasma
Official Title
Topical Silymarin Versus Combined Topical Silymarin and Microneedling in Treatment of Melasma: Split Face Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 2022 (Anticipated)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
Many studies examined multiple treatment options for melasma, but none of them is completely satisfactory with recurrence in most cases.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melasma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Each side of the patients' face will be randomly allocated to either topical silymarin 0.7% and microneedling or topical silymarin 0.7% alone.
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Silymarin alone versus silymarin and microneedling
Arm Type
Experimental
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Silymarin
Intervention Description
The patients will use topical silymarin 0.7% cream on the face twice daily(home use).
Intervention Type
Procedure
Intervention Name(s)
Microneedling
Intervention Description
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.
Primary Outcome Measure Information:
Title
compare between the efficacy of topical silymarin alone and its combination with microneedling in treatment of melasma.
Description
Scoring of the patients according to modified Melasma Area and Severity Index (mMASI) score before and after treatment.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age: 18-50 years old.
Pattern of melasma: Bilateral symmetrical facial melasma of any pattern.
Fitzpatrick skin phototypes: Types III, IV and V
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sahar A Ismail, Professor
Phone
+201008899446
Email
Saharsotohy@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Rofaida R Shehata, PHD
Phone
+201006897580
Email
rofaida.refaat@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
14510991
Citation
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.
Results Reference
background
PubMed Identifier
19406006
Citation
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.
Results Reference
background
PubMed Identifier
26549251
Citation
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.
Results Reference
background
PubMed Identifier
25184917
Citation
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.
Results Reference
background
PubMed Identifier
27755171
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.
Results Reference
background
PubMed Identifier
8002642
Citation
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.
Results Reference
background
PubMed Identifier
16170386
Citation
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.
Results Reference
background
PubMed Identifier
30146802
Citation
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.
Results Reference
background
PubMed Identifier
20398960
Citation
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.
Results Reference
background
PubMed Identifier
17760699
Citation
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.
Results Reference
background
PubMed Identifier
22212073
Citation
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.
Results Reference
background
Citation
Tran JM, Chan AW (2012) Quick diagnosis: melasma. University of Toronto Med J 89: 143-145.
Results Reference
background
PubMed Identifier
20372777
Citation
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.
Results Reference
background
PubMed Identifier
27047632
Citation
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.
Results Reference
background
Learn more about this trial
Silymarin Cream Versus Combined Silymarin Cream and Microneedling in Treatment of Melasma
We'll reach out to this number within 24 hrs