Comparison Between Isotretinoin, Silymarin and Both in the Treatment of Acne Vulgaris

Study Overview
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Brief Summary
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This study aims to compare the effects of isotretinoin and silymarin or both in treatment of acne and their effects on the level of IGF-1, SAA1 and malondialdehyde (MDA) in acne patients.

Detailed Description
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Acne vulgaris, a common and chronic disorder of the pilosebaceous unit, affects up to 85% of adolescent and young adults. The pathogenesis of acne is multifactorial. Traditionally, four distinct processes were believed to play critical roles: increased sebum production, alteration of keratinization processes leading to comedone formation, follicular colonization by Propionibacterium acnes (P.acnes) and inflammatory mediators around pilosebaceous unit. Orally administered isotretinoin is currently the only agent that can affect all four main factors implicated in acne. Serum insulin-like growth factor -1(IGF)-1 is a polypeptide hormone that has effects on sebocyte differentiation and proliferation. It leads to lipogenesis, and synthesis of inflammatory cytokines. IGF-1 also stimulates androgen synthesis leading to overproduction of sebum. Propionibacterium acnes can increase the release of serum amyloid A1 (SAA1) .There is significant elevation of SAA1 in patients with acne, with a positive correlation with its severity. Oxidative stress plays a role in the pathogenesis of acne in part due to the generation of reactive oxygen species (ROS) in response to infection by the bacterium Propionibacterium acnes, which colonizes the skin and grows in plugged hair follicles, thus attracting inflammatory cells, mainly neutrophils. These in turn secrete inflammatory mediators and generate ROS, which augments the inflammatory response and tissue damage. Silymarin, the main active component of milk thistle consists of a mixture of flavonolignans and flavonoid taxifolin. Silymarin acts as a hepatoprotective, anticancer, anti-inflammatory and immunomodulatory agent. Silymarin acts as a free radical scavenger, stabilizes the plasma membrane and reduces the production of inflammatory mediators produced by P. acnes, and scavenges the released free radicals.

Official Title
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Comparative Study Between the Effect of Isotretinoin, Silymarin and Their Combination in the Treatment of Patients With Acne Vulgaris

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: Isotretinoin ,silymarin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 16 years or more. Patient with moderate or severe acne. Not receiving acne treatment in the last month. Exclusion Criteria: Pregnancy or lactation. Patients with known hypersensitivity to isotretinoin or silymarin. Patients with depression, liver diseases or high cholesterol. Patients with acromegaly. Patients with chronic inflammatory, infective or neoplastic disorders.

Ages Eligible for Study
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Minimum Age: 16 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective controlled
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: acne vulgaris patients group 1<br>acne patients will be rondomly assigned to 1 of the 3 interventions (isotretinoin, silymarin, or both) | Drug: Isotretinoin ,silymarin<br>* 20mg/day isotretinoin for 3 months. 140 mg/day silymarin for 3 months. 20mg/day isotretinoin and 140mg/day silymarin for 3 months.<br>|
| Experimental: acne vulgaris patients group 2<br>acne patients will be rondomly assigned to 1 of the 3 interventions (isotretinoin, silymarin, or both) | Drug: Isotretinoin ,silymarin<br>* 20mg/day isotretinoin for 3 months. 140 mg/day silymarin for 3 months. 20mg/day isotretinoin and 140mg/day silymarin for 3 months.<br>|
| Experimental: acne vulgaris patients group 3<br>acne patients will be rondomly assigned to 1 of the 3 interventions (isotretinoin, silymarin, or both) | Drug: Isotretinoin ,silymarin<br>* 20mg/day isotretinoin for 3 months. 140 mg/day silymarin for 3 months. 20mg/day isotretinoin and 140mg/day silymarin for 3 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Acne Grading Classification | Global Acne Grading System (GAGS) Each is derived by multiplying the factors-2 for forehead, 2 for each check, 1 for nose, 1 for chin, 3 for both chest and back by the most heavily weighted lesion within each region (1 for ≥ one comedone, 2 for ≥ one papule,3 for ≥ one pustule, and 4 for ≥ one nodule). | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver function tests | Serum AST and ALT measure before and after 3 months therapy | 3 months | 
| Lipid profile | serum cholesterol, TG, LDL and HDL levels in blood before and after 3 months therapy | 3 months | 
| Insulin growth factor -1 | Assessment of IGF-1 level in blood before and after 3 months therapy | 3 months | 
| serum amyloid A1 | Assessment of serum amyloid A1 level before and after 3 months therapy | 3 months | 
| Malondialdehyde | Assessment of Malondialdehyde level in blood before and after 3 months therapy | 3 months |