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IRCT20191111045408N1 IRCT 2019-11-24 Mashhad University of Medical Sciences Evaluation of the effect of formulation Arctium Lappa in the treatment of Mild-to-moderate Acne Evaluation of the effect of topical formulation prepared from hydroalcoholic extract of Arctium Lappa's root in the treatment of mild and moderate Acne Vulgaris 2020-04-13 anticipated 100 Complete https://irct.ir/trial/43687 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Use simple randomization with the help of a listing provided by randomization.com, Blinding description: In this study, 100 patients with mild-to-moderate acne vulgaris referred to the special clinic of Ghaem Hospital, Mashhad, who met the inclusion criteria, will be enrolled after obtaining informed consent. Patients in groups A and B receive tretinoin gel, and then patients are randomly assigned to group A or B and receive placebo gel (B) or Arctium Lappa's gel (A) with tretinoin gel. Patients in groups C and D also receive tretinoin cream, which in turn will receive cream containing Arctium Lappa (C) or placebo (D). The first 50 patients will be divided between groups A and B and the next 50 patients will be divided between groups C and D. The placebo and herbal formulations will be delivered in the same package to the patients, which will have a very similar appearance and will be prepared by an individual other than the treating physician and the evaluating pharmacy student, distinguished only by the letters A, B, C or D, and The physician, pharmacy student, patient, and analyzer will remain unaware of the formulation until the work is completed. 3 ŮŽAcne Vulgaris. Intervention 1: Intervention group: Topical tretinoin formulation and Arctium Lappa topical formulation are applied once daily for three months on face skin. Intervention 2: Control group: Topical application of tretinoin twice daily for three months. Yes - There is a plan to make this available What will be shared: The information listed will be published in the form of an article. When: The article will be available through Infinite Journal. To whom: Anyone who needs them can access. Conditions: The data not published in this article will be provided in coordination with all project partners and research assistants of Mashhad University of Medical Sciences. Where to obtain: Email the person in charge How to obtain: The consent of all research associates of Mashhad University of Medical Sciences should be obtained. Comments:
public Amirreza Entezari
VakilAbad Blvd, School of Pharmacy
Mashhad Iran (Islamic Republic of) 17871 91886 +98 51 3180 1100 entezariar941@mums.ac.ir Mashhad University of Medical Sciences scientific Sepideh Elyasi
VakilAbad Blvd, School of Pharmacy
Mashhad Iran (Islamic Republic of) 17871 91886 31801100 051 elyasis@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Women and men aged 12-30 years with mild to moderate acne vulgaris Have signed the informed consent form 12 years 30 years Both Pregnant or breastfeeding or planning to become pregnant Have a history of sensitivity to the components of the formulations used in the study Other skin diseases such as eczema that make it difficult to evaluate the response to treatment Have uncontrolled systemic disease They have Acne Conglobata Not taking the following drugs before starting the plan (topical anti-acne drugs for two weeks, oral antibiotics for one month, 12 weeks hormone therapy and 6 months oral retinoids). L70.0 Acne vulgaris (or simply acne) is a long-term skin disease that occurs when hair follicles become clogged with dead skin cells and oil from the skin. Acne is characterized by areas of blackheads, whiteheads, pimples, and greasy skin, and may result in sca Treatment - Drugs Treatment - Drugs Intervention group: Topical tretinoin formulation and Arctium Lappa topical formulation are applied once daily for three months on face skin. Control group: Topical application of tretinoin twice daily for three months Acne Complication. Timepoint: One month after intervention, two months after intervention, three months after intervention. Method of measurement: Based on acne lesion counting. Mashhad University of Medical Sciences Approved 2019-09-21 Ethics committee of Mashhad University of Medical Sciences Mashhad,Daneshgah Ave,Central Organization of Mashhad University of Medical Sciences Mashhad Razavi Khorasan Iran (Islamic Republic of)