NCT05099601

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

Topical Silymarin Versus Combined Topical Silymarin and Microneedling in Treatment of Melasma: Split Face Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Melasma

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Silymarin	The patients will use topical silymarin 0.7% cream on the face twice daily(home use).
PROCEDURE	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.

Timeline

• Start date: 2022-05-01
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2021-10-29
• Last updated: 2021-10-29