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IRCT20150902023864N4 IRCT 2021-10-27 Bojnourd University of Medical Sciences Gel of tea tree oil nanoemulsion in treatment of acne Clinical trial of gel of tea tree oil nanoemulsion against clindamycin gel in treatment of acne 2021-11-22 anticipated 174 Complete https://irct.ir/trial/59296 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: To conceal the data, all the packs will be the same. each pack will contain a label so that the dispenser and the prescriber will not be aware of the contents. The sampling will be performed using Permuted Block Randomization. Group A: To do so, using the online software "Random number generator", block of treatment groups A and B will be generated. Group A: Tea tree oil nanoemulsion gel, Group B: Clindamycin gel Here is example of the first few blocks: AABB ABBA ABAB etc, Blinding description: Same packaging will be used. A code will be written on the packs. secretary will give the packs to the patients using a randomized list. The practitioner and the statistician will not be aware of the pack contents. 3 acne vulgaris. Intervention 1: Intervention group: gel of tea tree oil nanoemulsion: twice daily- after washing the affected area with soap and drying the skin, the medicine will be applied topically. Then, the area should not be washed for two hours. The treatment will continue for two weeks, then the patient will be visited again. Intervention 2: Control group: Clindamycin gel (commercial formulation available in the market)- twice daily- after washing the affected area with soap and drying the skin, the medicine will be applied topically. Then, the area should not be washed for two hours. The treatment will continue for two weeks, then the patient will be visited again. Yes - There is a plan to make this available What will be shared: All data potentially may be shared When: Nearly in 3 years To whom: All peaple Conditions: there is no condition Where to obtain: they can email the PI How to obtain: We do our best to deliver the data in a month Comments:
public Amir Amani
shahriar strett
Bojnurd Iran (Islamic Republic of) 9417694735 +98 58 3229 7157 amani76@gmail.com Bojnourd University of Medical Sciences scientific Amir Amani
No 90, Shahriar street
Bojnurd Iran (Islamic Republic of) 9417694735 +98 21 3229 7182 amani76@gmail.com Bojnourd University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) No use of any medicine (including body building agents) in the last 14 days Age: 15-30 years 15 years 30 years Both Pregnancy Lactation Hormone diseases Acute physical disability L70.0 Acne vulgaris Treatment - Drugs Treatment - Drugs Intervention group: gel of tea tree oil nanoemulsion: twice daily- after washing the affected area with soap and drying the skin, the medicine will be applied topically. Then, the area should not be washed for two hours. The treatment will continue for two weeks, then the patient will be visited again. Control group: Clindamycin gel (commercial formulation available in the market)- twice daily- after washing the affected area with soap and drying the skin, the medicine will be applied topically. Then, the area should not be washed for two hours. The treatment will continue for two weeks, then the patient will be visited again. Inflammatory and noninflammatory lesions. Timepoint: First day- 6th week. Method of measurement: counting lesions using manual lens. Side effects. Timepoint: first day and 6th week. Method of measurement: questionnaire (any possible side ffects). Bojnourd University of Medical Sciences Approved 2021-10-19 Ethics committee of north khorasan university of medical sciences N0. 91, shahriar street Bojnurd North Khorasan Iran (Islamic Republic of)