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IRCT20171122037581N1 IRCT 2018-01-02 Iran University of Medical Sciences Myrtus communis effect in acne treatment Evaluation of the effectiveness of herbal products of Myrtus communis compared with Clindamycin 1% in reducing symptoms of Acne Vulgaris ,mild to moderate 2017-12-06 anticipated 55 Complete https://irct.ir/trial/27789 interventional Randomization: N/A, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: The patients will receive two drug containers with the same shape and size but different content. each patient instructed to use antiacne1 on right side of the face and antiacne 2 on the left side. the patiant, the physician who will examine the patients and appraiser of them will not be aware of the contents of the drug containers. N/A Acne vulgaris. Intervention 1: Intervention group: the Myrtus communis topical formulation will be applied on one side of the face two times a day for 12 weeks. Intervention 2: Control group: the clindamycin1% will be applied on the other side of the face for 12 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Mahboobah Salmanian Haji Agha
School of Traditional Medicine, Behest Street, Vahdat Islami Street, Tehran
Tehran Iran (Islamic Republic of) 1449614535 +98 21 5563 9724 salma.ms219@gmail.com Iran University of Medical Sciences scientific Mahboobah Salmanian Haji Agha
School of Traditional Medicine, Behest Street, Vahdat Islami Street, Tehran
Tehran Iran (Islamic Republic of) 1114733311 +98 21 5515 2192 salma.ms219@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Being 12–45 years old Facial acne vulgaris, mild to moderate ( Having 20-140 total lesion count, 10-90 noninflammatory facial lesions, 10-50 inflammatory lesions, without facial nodular cystic lesion) 12 years 45 years Both Have a skin disease that might interfere with the diagnosis or evaluation of their skin lesions Severe systemic disease Pregnant and lactating women Use of topical anti acne therapy two months before or during the study Use of oral retinoids six months before the study known allergy or sensitivity to any of the study medications or their components Incidence of side effects Unwillingness to continue this study Unable to follow up the patient regularly L70.0 Acne vulgaris Treatment - Drugs Treatment - Drugs Intervention group: the Myrtus communis topical formulation will be applied on one side of the face two times a day for 12 weeks Control group: the clindamycin1% will be applied on the other side of the face for 12 weeks Total lesion Count. Timepoint: At the beginning of the study and at the end of the sixth, twelfth and sixteenth week of the study. Method of measurement: Counting the Comedones, Papules and Pustules. Severity of Acne. Timepoint: At the beginning of the study and at the end of the sixth, twelfth and sixteenth week of the study. Method of measurement: Acne Severity Index. Speed of onset of treatment(The mean time to a 50% reduction in acne lesion ) in every half of the face. Timepoint: At the end of the sixth and twelfth week. Method of measurement: Index of Severity of Acne=ASI Total lesion Count = TLC. Recurrence. Timepoint: 4 weeks after treatment. Method of measurement: Index of Severity of Acne=ASI Total lesion Count = TLC. Side effects. Timepoint: At the end of the sixth, twelfth and sixteenth week of the study. Method of measurement: Common terminology criteria for Adverse Evently v4.02009. Skin erythema. Timepoint: Before intervention and 16 weeks after the beginning of intervention. Method of measurement: Mexameter. Skin hydration. Timepoint: At the beginning of the study and the end of sixteenth week of the study. Method of measurement: Corneometer. Change in sebum production. Timepoint: At the beginning of the study and the end of sixteenth week of the study. Method of measurement: Sebumeter. Acne lesion and presence of Propionibacterium acnes bacteria. Timepoint: At the beginning of the study and the end of sixteenth week of the study. Method of measurement: Visiopor. Melanin. Timepoint: At the beginning of the study and the end of sixteenth week of the study. Method of measurement: Mexameter. Patient satisfaction. Timepoint: At the end of twelfth week. Method of measurement: questionnaire. Evaluation of drug tolerance by the patient on each side of the face(burning, pruritus). Timepoint: At the end of the sixth, twelfth and sixteenth week of the study. Method of measurement: questionnaire. Evaluation of drug tolerance by the physician on each side of the face(erythema, dryness, peeling). Timepoint: At the end of the sixth, twelfth and sixteenth week of the study. Method of measurement: examination. Iran University of Medical Sciences Approved 2017-10-08 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Hemmat Highway Tehran Tehran Iran (Islamic Republic of)