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
About this trial
This is an interventional treatment trial for Acne Vulgaris
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.
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
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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