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IRCT2014010516079N1 IRCT 2014-04-26 Vice chancellor for research, Isfahan University of Medical Sciences Dapsone gel in the treatment of papulopustular rosacea Comparison of dapsone 5% Topical gel with metronidazole 0.75% efficacy in combination with oral doxycycline In papulopustular rosacea 2013-04-10 anticipated 56 Complete https://irct.ir/trial/15143 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Double blinding in this study was done in a manner that both patients and researchers were not aware that which kind of exposure was done. In fact Metronidazloe and dapsone topical preparations had the same appearance and only by a code placed in an envelope it could be determined whether the agent is actual drug or placebo. N/A Papulopustular Rosacea. Intervention 1: Topical 5% dapsone gel were administered for group D and applied on the face twice daily for 12 weeks with systemic doxycycline capsule (Sobhan Darou Co.), 100 mg/day. Mode of use and application in the study: apply twice a day, every day, for 12 weeks .The cases are advised to wash the entire affected area with a mild cleanser and pat dry with a clean towel then apply a thin layer of the gel onto the entire affected area (a pea-sized amount will usually be enough), then gently and completely rub the gel right into their skin.In order to supply the dapsone gel , dapsone powder was dissolved in ethanol and then prepared in gel vehicle up to 5% concentration.Powder of dapsone , odorless crystalline powder, is applied in an aqueous gel base for topical dermatologic use. Base or vehicle of the gel is composed of: Diethylene Glycol Monoethyl Ether; Methylparaben; Sodium Hydroxide; and purified water.treatment and total follow up period was 12 weeks. Intervention 2: Topical 0.75% metronidazole gel were administered for group M and applied on the face twice daily for12 weeks with Systemic doxycycline capsule (Sobhan Darou Co.), 100 mg/day.Mode of Use and application in the study: apply twice a day, every day, for 12 weeks .The cases are advised to wash the entire affected area with a mild cleanser and pat dry with a clean towel then Apply a thin layer of the gel onto the entire affected area (a pea-sized amount will usually be enough), then gently and completely rub the gel right into their skin.Topical Metronidazole gel was prepared similar in shape, odor, size and color to dapsone gel, and applied in an aqueous gel base for topical dermatologic use. Base or vehicle of the gel is composed of: Diethylene Glycol Monoethyl Ether; Methylparaben; Sodium Hydroxide; and purified water.treatment and total follow up period was 12 weeks.
public Dr. Parastoo Khosravani
Dermatology group, Al-zahra hospital, Soffeh Blvd, Isfahan
Isfahan Iran (Islamic Republic of) +98 31 1625 5555 p_khosravani@resident.mui.ac.ir Isfahan University of Medical Sciences scientific Dr. Gita Faghihi
Dermatology group, Al-zahra hospital, Soffeh Blvd, Isfahan
Isfahan Iran (Islamic Republic of) +98 31 1625 5555 G_faghihi@med.mui.ac.ir Isfahan University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: age between 18 and 55, patients with papulopustular facial rosacea, negative history of using topical steroid or retinoic acid during last month, negative history of using oral anti-inflammatory agents and oral retinoic acids during last month and last 180 days respectively Exclusion criteria: Pregnancy or lactation, any history of G6PD deficiency, any history of hypersensitivity to dapsone or metronidazole, any history of oral cotrimoxasole treatment 18 years 55 years Both L71.8 Other rosacea Treatment - Drugs Treatment - Drugs Topical 5% dapsone gel were administered for group D and applied on the face twice daily for 12 weeks with systemic doxycycline capsule (Sobhan Darou Co.), 100 mg/day. Mode of use and application in the study: apply twice a day, every day, for 12 weeks .The cases are advised to wash the entire affected area with a mild cleanser and pat dry with a clean towel then apply a thin layer of the gel onto the entire affected area (a pea-sized amount will usually be enough), then gently and completely rub the gel right into their skin.In order to supply the dapsone gel , dapsone powder was dissolved in ethanol and then prepared in gel vehicle up to 5% concentration.Powder of dapsone , odorless crystalline powder, is applied in an aqueous gel base for topical dermatologic use. Base or vehicle of the gel is composed of: Diethylene Glycol Monoethyl Ether; Methylparaben; Sodium Hydroxide; and purified water.treatment and total follow up period was 12 weeks. Topical 0.75% metronidazole gel were administered for group M and applied on the face twice daily for12 weeks with Systemic doxycycline capsule (Sobhan Darou Co.), 100 mg/day.Mode of Use and application in the study: apply twice a day, every day, for 12 weeks .The cases are advised to wash the entire affected area with a mild cleanser and pat dry with a clean towel then Apply a thin layer of the gel onto the entire affected area (a pea-sized amount will usually be enough), then gently and completely rub the gel right into their skin.Topical Metronidazole gel was prepared similar in shape, odor, size and color to dapsone gel, and applied in an aqueous gel base for topical dermatologic use. Base or vehicle of the gel is composed of: Diethylene Glycol Monoethyl Ether; Methylparaben; Sodium Hydroxide; and purified water.treatment and total follow up period was 12 weeks. Rasoacea papulopustular lesions. Timepoint: Baseline, week 4, week 8, week 12. Method of measurement: Number of inflammatory lesions, Visual analogue score (VAS.) and Investigator’s global assessment scores (IGA.). Side effects of drug. Timepoint: Every 4 weeks. Method of measurement: clinical evaluation-laboratory test. Vice chancellor for research, Isfahan University of Medical Sciences Approved 2013-02-14 Ethics committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jerib Aven, Isfahan Isfahan Iran (Islamic Republic of)