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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melasma

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 2, 2021
    Last Updated
    October 19, 2021
    Sponsor
    Assiut University
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    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
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    Citation
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    Silymarin Cream Versus Combined Silymarin Cream and Microneedling in Treatment of Melasma

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