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IRCT2017072035195N1 IRCT 2017-10-23 Rasht University of Medical Sciences Dapson in acne vulgaris Comparison of the efficacy of dapsone 5% gel plus oral doxycycline versus benzoyl peroxide 5% gel plus oral doxycycline in patients with moderate acne vulgaris 2017-08-23 anticipated 60 Complete https://irct.ir/trial/26668 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible patients divide into two groups according to the randomized block design. The online website https://www.sealedenvelope.com is used to generate a randomized list of study groups. This list is compiled in the website on the basis of the intended sample size, with four-block sizes for 60 patients. After generating a list on the site, each individual is assigned a unique code and identified by it during the study, Blinding description: The above two topical drugs prepare in similar tubes. The patient, the prescribing physician and outcome assessor are unaware of the drug type. The drugs are provided to the patients at each visit by one of the dermatology ward staff who do not play a role in the diagnosis and treatment of patients. 2-3 Acne vulgaris. Intervention 1: In control group , benzoyl peroxide 5% Gel once daily for 3 months is adminestrated. Intervention 2: In cases group , Dapson 5% Gel once daily for 3 months is adminestrated. 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 I haven't decided yet - its release schedule is unclear.
public Dr Hojat Eftekhari
Razi hospital, Sardar Jangal Avenue, Rasht, Guilan, Iran
Rasht Iran (Islamic Republic of) 4144895655 +98 13 3355 0028 EFTEKHARI@GUMS.AC.IR Guilan University of Medical Sciences scientific Dr Hojat Eftekhari
Razi hospital, Sardar Jangal Avenue, Rasht, Guilan, Iran
Rasht Iran (Islamic Republic of) 4144895655 +98 13 3355 0028 Eftekhari@gums.ac.ir Rasht University of Medical Sciences Iran (Islamic Republic of) Patients with acne vulgaris who have 15-50 inflammatory lesions and 20-100 non-inflammatory lesions (comedones) (ranked as moderate in the GASS classification). The total number of lesions accounts for 30 to 120 (ranked as moderate in the GASS classification). 18 years 25 years Both Secondary acne due to other diseases or causes Using other oral or topical medicines to treat acne G6PD deficiency Severe nodular cystic acne (ranked as very severe in the GASS classification) Acne conglobata. L70.0 Acne vulgaris Treatment - Drugs Treatment - Drugs In control group , benzoyl peroxide 5% Gel once daily for 3 months is adminestrated. In cases group , Dapson 5% Gel once daily for 3 months is adminestrated. Inflammatory lesion (papule & pustule) non inflammatory (comedone). Timepoint: weeks 2, 4, 8, 12 after treatment. Method of measurement: GAAS Score. Side effects (Erythem, Burning, pruritus, Skin dryness, phototoxicity). Timepoint: weeks 2 , 4 , 8 , 12 after treatment. Method of measurement: History and examination. Rasht University of Medical Sciences Approved 2017-04-29 Ethics committee of University of Medical Sciences Razi hospital, Sardar Jangal Avenue, Rasht, Guilan, Iran Rasht Guilan Iran (Islamic Republic of)