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Silymarin Cream Versus Salicylic Acid in Treatment of Acne Vulgaris

Primary Purpose

Acne Vulgaris

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Silymarin
Salicylic acid
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients older than 18 years of age.
  • Patients with mild and moderate acne vulgaris.
  • Patients with Fitzpatrick skin type III, IV and V.

Exclusion Criteria:

  • Severe acne.
  • Patients under treatment with contraceptive pills or any kind of systemic or topic acne medication (isotretinoin, antibiotics, topical products).
  • History of hypertrophic/keloid scar formation.
  • Pregnancy.
  • Recurrent herpes infection.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Silymarin and salicylic acid

    Arm Description

    There will be one group of patients, that will use salicylic acid peeling on the right side of the face and topical Silymarin cream on the left side

    Outcomes

    Primary Outcome Measures

    Efficacy of the medication: number of inflammatory, non-inflammatory and total lesions
    counting the number of inflammatory, non-inflammatory and total lesions at baseline and every 4 weeks during the treatment
    assessment of tolerability: interviewing the patients
    interviewing the patients about any sign/symptom of adverse reactions (erythema, peeling, burning sensation, dryness and pruritus)

    Secondary Outcome Measures

    Full Information

    First Posted
    July 20, 2020
    Last Updated
    March 10, 2021
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04490967
    Brief Title
    Silymarin Cream Versus Salicylic Acid in Treatment of Acne Vulgaris
    Official Title
    Topical Silymarin Cream Versus Salicylic Acid Peeling in Treatment of Acne Vulgaris: Split Face Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2021 (Anticipated)
    Primary Completion Date
    December 2021 (Anticipated)
    Study Completion Date
    December 2021 (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
    Acne vulgaris is a disease of the pilosebaceous unit that causes noninflammatory lesions (open and closed comedones), inflammatory lesions (papules, pustules, and nodules), and varying degrees of scarring. Acne vulgaris is an extremely common condition with a lifetime prevalence of approximately 85% and occurs mostly during adolescence. Acne vulgaris leads to significant morbidity that is associated with residual scarring and psychological disturbances such as poor self-image, depression, and anxiety, which leads to a negative impact on quality of life. The treatment of acne vulgaris is challenging and often chronic, with high rates of failure and numerous choices. Frequent evaluations (i.e., every 8-12 weeks) are important to enable appropriate monitoring, manage adverse effects, and evaluate for medication compliance. Topical therapies are considered one of the mainstay treatments for patients with mild-to-moderate acne.
    Detailed Description
    Chemical peeling is one of the most common cosmetic procedures in medical practice and has been used for decades. It is defined as the application of chemical agents, of variable strength, on the skin that results in controlled destruction of the epidermis and dermis. The induced exfoliation is followed by dermal and epidermal regeneration from adjacent epithelium and skin adnexa, which results in improved surface texture and appearance of the skin. This is a simple and cost-effective procedure with several dermatological applications. Salicylic acid is a 2-hydroxybenzoic acid used for superficial peeling due to its strong keratolytic and comedolytic properties. It promotes shedding of epidermal cells and due to its lipophilic properties can penetrate comedones and pores to prevent clogging and neutralize bacteria. It promotes desquamation of the upper lipophilic layers of the stratum corneum. These chemical properties explain its popularity and success in acne patients. Also, it has well-documented anti-inflammatory properties. Silymarin is a standardized extract from S. marianum seeds, is traditionally used as a hepatoprotective agent for its potent regenerative properties. Lately, Silymarin is utilized in dermatological and cosmetic preparations for its antioxidant effect anti-inflammatory and immunomodulatory properties. Various studies have been created to evaluate the efficacy of Silymarin in UV protection, prevention against skin cancer and against actinic keratosis. Silymarin showed efficacy the treatment of Rosacea, Melasma, Vitiligo, Psoriasis, atopic dermatitis and contact dermatitis . Other studies showed that Silymarin has anti aging properties and potential action for wound healing .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acne Vulgaris

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Model Description
    Patients will use salicylic acid 30% peeling on the right side of the face and topical Silymarin 1.4% cream on the left side.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Silymarin and salicylic acid
    Arm Type
    Experimental
    Arm Description
    There will be one group of patients, that will use salicylic acid peeling on the right side of the face and topical Silymarin cream on the left side
    Intervention Type
    Combination Product
    Intervention Name(s)
    Silymarin
    Other Intervention Name(s)
    Silybin, Silybum, Marian thistle.
    Intervention Description
    Silymarin 1.4% cream will be used on the left side of the face twice daily (home use).
    Intervention Type
    Procedure
    Intervention Name(s)
    Salicylic acid
    Other Intervention Name(s)
    2-hydroxybenzoic acid
    Intervention Description
    Patients will have salicylic acid 30% peeling on the right side of the face as a peeling session every two weeks. Sessions will be done by well trained physician.
    Primary Outcome Measure Information:
    Title
    Efficacy of the medication: number of inflammatory, non-inflammatory and total lesions
    Description
    counting the number of inflammatory, non-inflammatory and total lesions at baseline and every 4 weeks during the treatment
    Time Frame
    12 weeks
    Title
    assessment of tolerability: interviewing the patients
    Description
    interviewing the patients about any sign/symptom of adverse reactions (erythema, peeling, burning sensation, dryness and pruritus)
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients older than 18 years of age. Patients with mild and moderate acne vulgaris. Patients with Fitzpatrick skin type III, IV and V. Exclusion Criteria: Severe acne. Patients under treatment with contraceptive pills or any kind of systemic or topic acne medication (isotretinoin, antibiotics, topical products). History of hypertrophic/keloid scar formation. Pregnancy. Recurrent herpes infection.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    D A Ahmed, Professor
    Phone
    +20 100 567 7229
    Email
    daliaattallah@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    A Y Badran, PHD
    Phone
    +20 101 324 4819
    Email
    aya_badran@yahoo.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
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    Silymarin Cream Versus Salicylic Acid in Treatment of Acne Vulgaris

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