A Phase 4 interventional study of Silymarin and Microneedling in Melasma, sponsored by Assiut University. Status unknown. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2021-10-29.
Sponsored by Assiut University · Phase 4, Interventional, and Treatment
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.
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.
149 studies on the registry are indexed under Melanosis; 38 are open to participants now.
This study's planned enrollment of 30 is below the median of 40 across 139 interventional studies indexed under Melanosis.
Browse Melanosis studies →Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
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
The patients will use topical silymarin 0.7% cream on the face twice daily(home use).
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.
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.
Time frame: 3 months
No study locations are listed for this record.
Plan to share: Undecided
This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Assiut University