A Phase 4 interventional study of Isotretinoin ,silymarin in Acne Vulgaris, sponsored by Tanta University. Status unknown at 1 site in Egypt. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2022-12-28.
Sponsored by Tanta University · Phase 4, Interventional, and Treatment
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.
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.
731 studies on the registry are indexed under Acne Vulgaris; 87 are open to participants now.
This study's planned enrollment of 75 is close to the median of 69 across 629 interventional studies indexed under Acne Vulgaris.
Browse Acne Vulgaris studies →Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
acne patients will be rondomly assigned to 1 of the 3 interventions (isotretinoin, silymarin, or both)
Drug: Isotretinoin ,silymarin
acne patients will be rondomly assigned to 1 of the 3 interventions (isotretinoin, silymarin, or both)
Drug: Isotretinoin ,silymarin
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.
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).
Time frame: 3 months
Liver function tests
Serum AST and ALT measure before and after 3 months therapy
Time frame: 3 months
Lipid profile
serum cholesterol, TG, LDL and HDL levels in blood before and after 3 months therapy
Time frame: 3 months
Insulin growth factor -1
Assessment of IGF-1 level in blood before and after 3 months therapy
Time frame: 3 months
serum amyloid A1
Assessment of serum amyloid A1 level before and after 3 months therapy
Time frame: 3 months
Malondialdehyde
Assessment of Malondialdehyde level in blood before and after 3 months therapy
Time frame: 3 months
Plan to share: No
This study is status unknown, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Tanta University