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Silymarin Cream Versus Salicylic Acid in Treatment of Acne Vulgaris

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04490967
Collaborator
(none)
30
Enrollment
1
Arm
8
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Combination Product: Silymarin
  • Procedure: Salicylic acid
 Phase 4

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 .

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention 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.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)
Primary Purpose:
Treatment
Official Title:
Topical Silymarin Cream Versus Salicylic Acid Peeling in Treatment of Acne Vulgaris: Split Face Study
Anticipated Study Start Date :
Apr 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Silymarin and salicylic acid

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

Combination Product: Silymarin
Silymarin 1.4% cream will be used on the left side of the face twice daily (home use).
Other Names:
  • Silybin, Silybum, Marian thistle.

    • Procedure: Salicylic acid
    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.
    Other Names:
  • 2-hydroxybenzoic acid

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Efficacy of the medication: number of inflammatory, non-inflammatory and total lesions [12 weeks]

      counting the number of inflammatory, non-inflammatory and total lesions at baseline and every 4 weeks during the treatment

    2. assessment of tolerability: interviewing the patients [12 weeks]

      interviewing the patients about any sign/symptom of adverse reactions (erythema, peeling, burning sensation, dryness and pruritus)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Alaa Gamal Ahmed Makhlouf, Principal investigator, Assiut University
    ClinicalTrials.gov Identifier:
    NCT04490967
    Other Study ID Numbers:
    • SMVSA
    First Posted:
    Jul 29, 2020
    Last Update Posted:
    Mar 12, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Acne Vulgaris
    Salicylic Acid
    Salicylates
    Silybin
    Silymarin

    Study Results

    No Results Posted as of Mar 12, 2021