Comparison Between Isotretinoin, Silymarin and Both in the Treatment of Acne Vulgaris
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: acne vulgaris patients group 1 acne patients will be rondomly assigned to 1 of the 3 interventions (isotretinoin, silymarin, or both) |
Drug: Isotretinoin ,silymarin
20mg/day isotretinoin for 3 months. 140 mg/day silymarin for 3 months. 20mg/day isotretinoin and 140mg/day silymarin for 3 months.
|
| Experimental: acne vulgaris patients group 2 acne patients will be rondomly assigned to 1 of the 3 interventions (isotretinoin, silymarin, or both) |
Drug: Isotretinoin ,silymarin
20mg/day isotretinoin for 3 months. 140 mg/day silymarin for 3 months. 20mg/day isotretinoin and 140mg/day silymarin for 3 months.
|
| Experimental: acne vulgaris patients group 3 acne patients will be rondomly assigned to 1 of the 3 interventions (isotretinoin, silymarin, or both) |
Drug: Isotretinoin ,silymarin
20mg/day isotretinoin for 3 months. 140 mg/day silymarin for 3 months. 20mg/day isotretinoin and 140mg/day silymarin for 3 months.
|
Outcome Measures
Primary Outcome Measures
- Global Acne Grading Classification [3 months]
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).
Secondary Outcome Measures
- Liver function tests [3 months]
Serum AST and ALT measure before and after 3 months therapy
- Lipid profile [3 months]
serum cholesterol, TG, LDL and HDL levels in blood before and after 3 months therapy
- Insulin growth factor -1 [3 months]
Assessment of IGF-1 level in blood before and after 3 months therapy
- serum amyloid A1 [3 months]
Assessment of serum amyloid A1 level before and after 3 months therapy
- Malondialdehyde [3 months]
Assessment of Malondialdehyde level in blood before and after 3 months therapy
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tanta University | Tanta | Egypt |
Sponsors and Collaborators
- Tanta University
Investigators
- Study Chair: Ghada F Hassan, A.professor, Tanta University
- Study Chair: Dalia R Elafify, Doctor, Tanta University
Study Documents (Full-Text)
None provided.More Information
Publications
- Hazarika N. Acne vulgaris: new evidence in pathogenesis and future modalities of treatment. J Dermatolog Treat. 2021 May;32(3):277-285. doi: 10.1080/09546634.2019.1654075. Epub 2019 Aug 29.
- Shie Morteza M, Hayati Z, Namazi N, Abdollahimajd F. Efficacy and safety of oral silymarin in comparison with oral doxycycline and their combination therapy in the treatment of acne vulgaris. Dermatol Ther. 2019 Nov;32(6):e13095. doi: 10.1111/dth.13095. Epub 2019 Oct 21.
- Treatment of acne vulgaris