Silymarin Cream Versus Salicylic Acid in Treatment of Acne Vulgaris

Study Overview
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Brief Summary
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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
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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 .

Official Title
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Topical Silymarin Cream Versus Salicylic Acid Peeling in Treatment of Acne Vulgaris: Split Face Study

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Combination Product: Silymarin
* Procedure: Salicylic acid


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Silymarin and salicylic acid<br>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<br>* Silymarin 1.4% cream will be used on the left side of the face twice daily (home use).<br>* Other names: Silybin, Silybum, Marian thistle.;Procedure: Salicylic acid<br>* 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.<br>* Other names: 2-hydroxybenzoic acid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 weeks | 
| assessment of tolerability: interviewing the patients | interviewing the patients about any sign/symptom of adverse reactions (erythema, peeling, burning sensation, dryness and pruritus) | 12 weeks |