Protocol summary
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Study aim
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compare the therapeutic effects of Dapsone 5% gel plus oral doxycycline versus Benzoyl peroxide 5% gel plus oral Doxycycline
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Design
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The present study is a double blind randomized clinical trial with a 1 : 1 allocation ratio.
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Settings and conduct
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patients with acne vulgaris aged 18 to 25 years refer to dermatology clinic at Rasht Razi Hospital during September 2017 to March 2018 with inclusion criteria after obtaining informed consent.
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Participants/Inclusion and exclusion criteria
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The inclusion criteria involved the patients with acne vulgaris who have 15-50 inflammatory lesions and 20-100 non-inflammatory lesions (comedones) or the total number of lesions accounts for 30 to 120 (ranked as moderate in the GASS classification). The exclusion criteria included 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), and Acne conglobata.
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Intervention groups
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for intervention group Dapsone 5% gel and for control group topical Benzoyl peroxide 5% gel are prescribed.
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Main outcome variables
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Decrease in inflammatory and non-inflammatory lesions
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2017072035195N1
Registration date:
2017-10-23, 1396/08/01
Registration timing:
registered_while_recruiting
Last update:
2019-10-04, 1398/07/12
Update count:
1
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Registration date
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2017-10-23, 1396/08/01
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Deputy of Researh and Technology of Guilan University of Medical Sciences
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Expected recruitment start date
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2017-08-23, 1396/06/01
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Expected recruitment end date
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2018-02-20, 1396/12/01
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Actual recruitment start date
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2017-09-23, 1396/07/01
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Actual recruitment end date
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2018-03-19, 1396/12/28
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Trial completion date
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2018-05-22, 1397/03/01
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Scientific title
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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
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Public title
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Dapson in acne vulgaris
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
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).
Exclusion criteria:
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.
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Age
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From 18 years old to 25 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
60
Actual sample size reached:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-04-29, 1396/02/09
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Ethics committee reference number
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ir.gums.rec.1396.26
Health conditions studied
1
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Description of health condition studied
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Acne vulgaris
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ICD-10 code
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L70.0
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ICD-10 code description
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Acne vulgaris
Primary outcomes
1
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Description
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inflammatory lesion (papule & pustule) non inflammatory (comedone)
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Timepoint
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weeks 2, 4, 8, 12 after treatment
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Method of measurement
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GAAS Score
Secondary outcomes
1
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Description
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Side effects (Erythem, Burning, pruritus, Skin dryness, phototoxicity)
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Timepoint
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weeks 2 , 4 , 8 , 12 after treatment
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Method of measurement
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History and examination
Intervention groups
1
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Description
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In control group , benzoyl peroxide 5% Gel once daily for 3 months is adminestrated.
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Category
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Treatment - Drugs
2
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Description
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In cases group , Dapson 5% Gel once daily for 3 months is adminestrated.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Rasht University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available