Acne vulgaris 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 acne treatment .This study aimed to evaluate the efficacy of combination of 5% dapsone gel and systemic Isotretinoin in acne vulgaris. A Double-blind(both patients and practitioners were blind to the trial), randomized, placebo-controlled, clinical trial was done on 58 young adults (18-25 Years) with clinically diagnosed moderate to severe acne vulgaris.The inclusion criteria were Age between 18 and 25 years old and moderate to severe acne vulgaris and exclusion criteria were acne due to secondary disorders , pregnancy and lactation. The patients were divided into two groups using table of randomization: (group A: treated by 5% dapsone gel plus isotretinoin and group B: vehicle neutral gel plus isotretinoin). All patients were administered oral Isotretinoin (Roaccutan) 20 mg once a day. They received topical treatment on their face twice daily for 8 weeks.In order to supply the dapsone gel, dapsone powder was dissolved in ethanol and then prepared in gel vehicle up to 5% concentration.
An objective clinical scoring (The Global Acne Assessment Score) and the number of inflamed and non-inflamed facial lesions and side effects of treatment were documented on base line and weeks 4, 8 and 12.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014011015509N1
Registration date:2014-04-07, 1393/01/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-04-07, 1393/01/18
Registrant information
Name
Mehrdad RakhshanPour
Name of organization / entity
Isfahan university of medical sciences.
Country
Iran (Islamic Republic of)
Phone
+98 31 1458 8136
Email address
m_rakhshan_md@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2013-01-18, 1391/10/29
Expected recruitment end date
2013-05-18, 1392/02/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of 5% dapsone gel plus oral isotretinoin with oral isotretinoin alone in young patients with moderate to severe facial acne
Public title
Treatment of acne with dapsone gel plus oral isotretinoin
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 18 and 25 years old; moderate to severe facial acne; absence of contraindications to treatment with tablets of isotretinoin and 5% dapsone gel.
Exclusion criteria: acne secondary to other problems; pregnancy or intention to become pregnant; breastfeeding; another dermatological disease of the face; G6PD deficiency; and known hypersensitivity to dapsone or isotretinoin.
Age
From 18 years old to 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
58
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
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 placebo and actual drug 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
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave. Isfahan
City
Isfahan
Postal code
Approval date
2013-01-23, 1391/11/04
Ethics committee reference number
392090
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
Acne vulgaris lesions
Timepoint
Baseline, weeks 4, weeks 8, weeks 12.
Method of measurement
Total Acne lesion Count( TLC.) and The Global Acne Assessment Score for each patient
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 was applied on the face twice daily for 8 weeks with Isotretinoin (Roaccutan) 20 mg daily.Mode of Use and application in the study: apply twice a day, every day, for 8 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 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 period was 8 weeks and total follow up period was 12 weeks.
Category
Treatment - Drugs
2
Description
Vehicle neutral gel was applied on the face twice daily for 8 weeks with Isotretinoin (Roaccutan) 20 mg daily.Mode of Use and application in the study: apply twice a day, every day, for 8 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 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. treatment period was 8 weeks and total follow up period was 12 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital, Dermatology Clinic
Full name of responsible person
Dr. Mehrdad Rakhshanpour
Street address
Department of Dermatology, Alzahra Hospital, Soffeh Blvd. Isfahan
City
Isfahan
2
Recruitment center
Name of recruitment center
Dermatology Clinic of Noor and Ali Asghar Hospital
Full name of responsible person
Dr. Mehrdad Rakhshanpour
Street address
Noor and Ali Asghar Hospital, Ostandari Ave. Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Isfahan University of Medical Sciences
Full name of responsible person
Dr. Ebrahim Esfandiari, Vice Chancellor for research, Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave. Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Isfahan University of Medical Sciences