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

Phase 4

• Conditions: Melasma
• Interventions: Combination Product: Silymarin; Procedure: Microneedling

• Registration Number: NCT05099601
• Lead Sponsor: Assiut University

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.

Study Timeline

• Status Verified: 2021-10
• Study First Submitted: 2021-10-02
• Study First Submitted QC: 2021-10-19
• Last Update Submitted: 2021-10-19
• Study First Posted: 2021-10-29
• Last Update Posted: 2021-10-29
• Study Start: 2022-05
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Silymarin alone versus silymarin and microneedling	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 alone versus silymarin and microneedling	Silymarin	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.

Primary Outcome Measures

Name	Time	Method
compare between the efficacy of topical silymarin alone and its combination with microneedling in treatment of melasma.	3 months	Scoring of the patients according to modified Melasma Area and Severity Index (mMASI) score before and after treatment.