Acne vulgaris. Acne vulgaris
Conditions
Interventions
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
Sponsors
Iran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
12 Years to 45 Years
Inclusion criteria
Inclusion criteria: 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)
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMahboobah Salmanian Haji Agha
Iran University of Medical Sciences
Outcome results
None listed