Comparison Between Isotretinoin, Silymarin and Both in the Treatment of Acne Vulgaris
NCT ID: NCT05666765
Last Updated: 2022-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
75 participants
INTERVENTIONAL
2023-01-01
2024-01-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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acne vulgaris patients group 1
acne patients will be rondomly assigned to 1 of the 3 interventions (isotretinoin, silymarin, or both)
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.
acne vulgaris patients group 2
acne patients will be rondomly assigned to 1 of the 3 interventions (isotretinoin, silymarin, or both)
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.
acne vulgaris patients group 3
acne patients will be rondomly assigned to 1 of the 3 interventions (isotretinoin, silymarin, or both)
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
16 Years
ALL
No
Sponsors
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Tanta University
OTHER
Responsible Party
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Ghada mohamed abdelmonem mohamed Tantawy
Principle investigator
Principal Investigators
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Ghada F Hassan, A.professor
Role: STUDY_CHAIR
Tanta University
Dalia R Elafify, Doctor
Role: STUDY_CHAIR
Tanta University
Locations
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Tanta University
Tanta, , Egypt
Countries
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Central Contacts
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Sahar M El-hagger, Professor
Role: CONTACT
Phone: 0020403336007
Facility Contacts
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Dalia R Elafify, Doctor
Role: primary
References
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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.
Other Identifiers
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Treatment of acne vulgaris
Identifier Type: -
Identifier Source: org_study_id