Rosacea is an inflammatory disease of the pilosebaceous units. Various systemic and topical options are available for its treatment. Topical dapsone is an antibacterial and anti-inflammatory agent for rosacea treatment. The goal of this study is comparison between topical dapsone 5% gel with metronidazole 0.75% gel efficacy in combination with oral doxycycline in treatment of facial papulopustular rosacea. This study is a double blind (both patients and practitioners were blind to the trial), randomized, clinical trial. This study contains two randomized group using table of randomization and 28 patients present in each group (in total 56 patients). Fifty six adult (18-55 years) patients with at least 5 lesions of papulopustular rosacea were enrolled. Inclusion criteria were age between 18 and 55, patients with papulopustular facial rosacea and exclusion criteria were pregnancy or lactation, any history of G6PD deficiency or history of hypersensitivity to dapsone or metronidazole. The severity of disorder was determined by the patient according to visual analogue score (VAS) Investigator’s global assessment (IGA) scores and number of inflammatory lesions were recorded. 5% dapsone gel was administered for group D and 0.75% metronidazole gel was administered for group M. Systemic doxycycline was administered for all patients. follow up assessments were done at 4, 8 and 12 weeks. The primary end points were change in IGA scores and number of inflammatory lesions.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014010516079N1
Registration date:2014-04-26, 1393/02/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-04-26, 1393/02/06
Registrant information
Name
Parastoo Khosravani
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1669 3682
Email address
p_khosravani@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Isfahan University of Medical Sciences
Expected recruitment start date
2013-04-10, 1392/01/21
Expected recruitment end date
2013-11-01, 1392/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of dapsone 5% Topical gel with metronidazole 0.75% efficacy in combination with oral doxycycline In papulopustular rosacea
Public title
Dapsone gel in the treatment of papulopustular rosacea
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
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.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jerib Aven, Isfahan
City
Isfahan
Postal code
Approval date
2013-02-14, 1391/11/26
Ethics committee reference number
39208
Health conditions studied
1
Description of health condition studied
Papulopustular Rosacea
ICD-10 code
L71.8
ICD-10 code description
Other rosacea
Primary outcomes
1
Description
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.)
Secondary outcomes
1
Description
Side effects of drug
Timepoint
Every 4 weeks
Method of measurement
clinical evaluation-laboratory test
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.