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

Acne Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05666765
• Other study ID #: Treatment of acne vulgaris
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: January 1, 2023
• Est. completion date: January 1, 2024

Study information

• Verified date: December 2022
• Source: Tanta University
• Contact: Ghada M Tantawy, Doctor
• Phone: 00201144062267
• Email: Ghadamtantawy[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Est. completion date: January 1, 2024
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

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.

Locations

Country	Name	City	State
Egypt	Tanta University	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

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