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
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04321070 -
Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris
|
Phase 1 | |
| Recruiting |
NCT05755256 -
The Impact of Probiotics on Skin Hydration in Youth With Mild Acne
|
Phase 2 | |
| Completed |
NCT05131373 -
Safety, Tolerability, and Immunogenicity of ORI-A-ce001 for the Treatment of Acne Vulgaris
|
Phase 1 | |
| Completed |
NCT01445301 -
Study STF115287, a Clinical Confirmation Study of GSK2585823 in the Treatment of Acne Vulgaris in Japanese Subjects
|
Phase 3 | |
| Completed |
NCT03303170 -
Non-Significant Risk Study of Sebacia Microparticles in the Treatment of Facial Acne Vulgaris
|
N/A | |
| Completed |
NCT04698239 -
Clinical Evaluation of the Safety and Benefits of the Milesman 445 nm Blue Laser on Inflammatory Acne Lesions.
|
N/A | |
| Completed |
NCT02886715 -
A Study Comparing Tazarotene Cream 0.1% to TAZORAC® (Tazarotene) Cream 0.1% and Both to a Placebo Control in the Treatment of Acne Vulgaris
|
Phase 3 | |
| Terminated |
NCT02924428 -
Venus Versa Diamondpolar Applicator Treatment Followed by AC Dual Applicator Treatment for Facial Acne Vulgaris
|
N/A | |
| Completed |
NCT02709902 -
Study Comparing Adapalene/BP Gel to EPIDUO® FORTE and Both to a Placebo Control in Treatment of Acne Vulgaris
|
Phase 1 | |
| Not yet recruiting |
NCT02535871 -
A Study Comparing the Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris
|
Phase 3 | |
| Not yet recruiting |
NCT02491060 -
A Study Comparing the Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris
|
Phase 3 | |
| Not yet recruiting |
NCT02525822 -
Study to Compare the Safety and Efficacy of IDP-123 Lotion to Tazorac Cream in the Treatment of Acne Vulgaris
|
Phase 2 | |
| Completed |
NCT02913001 -
The Effect of a Low Glycemic Load Diet on Hormonal Markers Associated With Acne
|
N/A | |
| Completed |
NCT02250430 -
A Phase 1 Study Assessing Local Cutaneous Effects of SB204
|
Phase 1 | |
| Completed |
NCT01769664 -
A Study Comparing Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel to Duac® Topical Gel in the Treatment of Acne Vulgaris
|
Phase 1 | |
| Completed |
NCT01694810 -
Cutaneous Tolerability and Safety of NVN1000 Topical Gel in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT01727440 -
Identifying the Genetic Predictors of Severe Acne Vulgaris and the Outcome of Oral Isotretinoin Treatment
|
N/A | |
| Completed |
NCT01194375 -
A Dose-Ranging Study Evaluating the Safety and Efficacy of IDP-107 in Patients With Acne Vulgaris
|
Phase 2 | |
| Completed |
NCT00991198 -
The Role of Topically Dissolved Oxygen (TDO) to Ameliorate Signs of Photodamage
|
Phase 2 | |
| Completed |
NCT02524665 -
8 Week Study to Evaluate and Compare the Efficacy and Tolerability of MAXCLARITY II and MURAD To Treat Acne
|
Phase 4 |