Comparison of the efficacy and tolerability of adapalene gel 0.1% versus tretinoin gel 0.05% in patients with mild to moderate acne vulgaris: a double blinded randomized clinical trial
Objectives: To compare the efficacy and tolerability of adapalene gel 0.1% versus tretinoin gel 0.05% in patients with mild to moderate acne vulgaris.
Design: A double blinded randomized clinical trial.
Setting and conduct: All eligible patients with mild to moderate acne vulgaris who will refer to clinic of Farshchian Hospital during the study period will be enrolled in to the trial.
Inclusion criteria: Any patient with mild to moderate acne vulgaris without limitation of age and gender.
Exclusion criteria: (a) Pregnancy or breast feeding; (b) using medication that have interaction with the drug under study.
Intervention: Rubbing adapalene gel 0.1% on the area of facial acne lesion once a day for 12 weeks.
Control: Rubbing tretinoin gel 0.05% on the area of facial acne lesion once a day for 12 weeks.
Primary outcome: Evaluation of the improvement of based on the Global Acne Grading System with comparison of the photos taken from the location of the lesions at zero time and then at 4th and 12th weeks after treatment.
Secondary outcome: (a) local dry skin through physical examination at 4th and 12th weeks after treatment; (b) local erythema through physical examination at 4th and 12th weeks after treatment; (c) local skin irritation through taking history of the patient at 4th and 12th weeks after treatment
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201403109014N31
Registration date:2014-03-25, 1393/01/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-03-25, 1393/01/05
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
1991-12-01, 1370/09/10
Expected recruitment end date
1992-08-30, 1371/06/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy and tolerability of adapalene gel 0.1% versus tretinoin gel 0.05% in patients with mild to moderate acne vulgaris: a double blinded randomized clinical trial
Public title
Comparison of the efficacy and tolerability of adapalene gel 0.1% versus tretinoin gel 0.05% in patients with mild to moderate acne vulgaris
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Any patient with mild to moderate acne vulgaris without limitation of age and gender.
Exclusion criteria: (a) Pregnancy or breast feeding; (b) using medication that have interaction with the drug under study.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization: 48 cans of the same color and size including 24 cans have adapalene gel 0.1% and 24 cans have tretinoin gel 0.05% will be numbered and then will be given to the patients at random.
Blinding: The patients will receive cans with the same shape but different content. Thus, they will not aware of the intervention. Furthermore, the physician who will examine the patients will not be aware of the intervention. Thus, the design of the study will be double blinded.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethic Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2013-02-14, 1391/11/26
Ethics committee reference number
D/P/16/35/9/4024
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
Evaluation of the improvement of acne lesions
Timepoint
at zero time and then at 4th and 12th weeks after treatment
Method of measurement
based on the Global Acne Grading System with comparison of the photos taken from the location of the lesions
Secondary outcomes
1
Description
local dry skin
Timepoint
at 4th and 12th weeks after treatment
Method of measurement
through physical examination
2
Description
local erythema
Timepoint
at 4th and 12th weeks after treatment
Method of measurement
through clinical examination
3
Description
local skin irritation
Timepoint
at 4th and 12th weeks after treatment
Method of measurement
through taking history of the patient
Intervention groups
1
Description
Rubbing adapalene gel 0.1% on the area of facial acne lesion once a day for 12 weeks.
Category
Treatment - Drugs
2
Description
Rubbing tretinoin gel 0.05% on the area of facial acne lesion once a day for 12 weeks
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Hospital
Full name of responsible person
Dr Bita Sharafi
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
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 the Technology, Hamadan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Farshchian Hospital
Full name of responsible person
Dr Bita Sharafi
Position
Resident of Dermatology
Other areas of specialty/work
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave
City
Hamadan
Postal code
Phone
+98 81 1838 1086
Fax
Email
bita_sharafi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Farshchian Hospital
Full name of responsible person
Dr Akram Ansar
Position
Dermatologist
Other areas of specialty/work
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave
City
Hamadan
Postal code
Phone
+98 81 1838 1086
Fax
Email
ansar@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)