Silymarin Cream Versus Salicylic Acid in Treatment of Acne Vulgaris

NCT04490967 | Unknown Phase 4

• 1 other identifier: SMVSA
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Silymarin and salicylic acid

EXPERIMENTAL

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; Procedure: Salicylic acid

Interventions

Silymarin COMBINATION_PRODUCT

Silymarin 1.4% cream will be used on the left side of the face twice daily (home use).

Also known as: Silybin, Silybum, Marian thistle.

Silymarin and salicylic acid

Salicylic acid PROCEDURE

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.

Also known as: 2-hydroxybenzoic acid

Silymarin and salicylic acid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (31)

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MeSH Terms

Conditions

Acne Vulgaris

Interventions

Silymarin; Silybin; Salicylic Acid

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Flavonolignans; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Salicylates; Hydroxybenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols

Central Study Contacts

D A Ahmed, Professor

CONTACT

+20 100 567 7229; daliaattallah@yahoo.com

A Y Badran, PHD

CONTACT

+20 101 324 4819; aya_badran@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Patients will use salicylic acid 30% peeling on the right side of the face and topical Silymarin 1.4% cream on the left side.

Study Record Dates

• First Submitted: July 20, 2020
• First Posted: July 29, 2020
• Study Start: April 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 12, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share