Silymarin Cream Versus Salicylic Acid in Treatment of Acne Vulgaris

March 10, 2021 updated by: Alaa Gamal Ahmed Makhlouf, Assiut University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of the medication: number of inflammatory, non-inflammatory and total lesions
Time Frame: 12 weeks
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
Time Frame: 12 weeks
interviewing the patients about any sign/symptom of adverse reactions (erythema, peeling, burning sensation, dryness and pruritus)
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2021

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

July 20, 2020

First Submitted That Met QC Criteria

July 27, 2020

First Posted (Actual)

July 29, 2020

Study Record Updates

Last Update Posted (Actual)

March 12, 2021

Last Update Submitted That Met QC Criteria

March 10, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMVSA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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