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 referred to Rasht Razi hospital during 2017-2018.
This is an interventional study to compare the therapeutic effects of Dapsone 5% gel plus oral doxycycline versus Benzoyl peroxide 5% gel plus oral Doxycycline. It is performed as a randomized double-blinded two-arm study. Thirty patients will be enrolled in each group and all patients will be followed up for 3 months. Oral doxycycline capsule 100 mg is administered for both groups, for control group topical Benzoyl peroxide 5% gel and for intervention group Dapsone 5% gel are prescribed.
Both groups are selected from patients referred to Dermatology clinic of Rasht Razi Hospital during 2017-2018. Study duration will be 14 months and decrease in inflammatory and non-inflammatory lesions will be compared in both groups as the primary outcome.
Inclusion criteria are patients aged 18 to 25 years with moderate acne vulgaris and normal levels of Glucose 6-phosphate dehydrogenase enzyme.
Exclusion criteria are acne due to systemic diseases, previous treatment of acne with other oral or topical medications, Glucose 6-phosphate dehydrogenase deficiency, severe cystic or progressive nodular acne (acne conglobate), sulfa allergy, pregnant or lactating women and other skin diseases involving the face.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017072035195N1
Registration date:2017-10-23, 1396/08/01
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2017-10-23, 1396/08/01
Registrant information
Name
Hojat Eftekhari
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3355 0028
Email address
eftekhari@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Researh and Technology of Guilan University of Medical Sciences
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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 referred to Rasht Razi hospital during 2017-2018.
Public title
Dapson in acne vulgaris
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria are patients aged 18 to 25 with moderate Acne vulgaris and normal levels of Glucose 6 phosphate dehydrogenase enzyme.
exclusion criteria are Acne secondary to other diseases, use of other oral or topical medications for acne, Glucose 6 phosphate dehydrogenase deficiency, Severe cystic acne, conglobata, or progressive nodular acne, Allergy to sulfone drugs or using sulfone drugs, antimalarial drugs and Co-trimoxazole, pregnant or lactating women, and other skin disease involving the face.
Age
From 18 years old to 25 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Guilan university of medical science
Street address
Guilan university of medical science
City
rasht
Postal code
Approval date
2017-04-29, 1396/02/09
Ethics committee reference number
ir.gums.rec.1396.26
Health conditions studied
1
Description of health condition studied
Acne vulgaris
ICD-10 code
L70.0
ICD-10 code description
Acne vulgaris
Primary outcomes
1
Description
inflammatory lesion(papule&pustule) non inflammatory(comedone)
Timepoint
weeks 2,4,8,12 after treatment
Method of measurement
GAAS Score
2
Description
inflammatory lesion(papule&pustule) non inflammatory(comedone)