The comparison of therapeutic effect on severity and number of skin lesions, between metformin semisolid formulation and placebo, in patients with mild to moderate Acne vulgaris.
The goal of this study, is the evaluation of topical semisolid metformin formulation effect on severity and number of skin lesions in patients, suffering from mild to moderate Acne vulgaris. The patients with mild to moderate acne will be included in study. The samples which are diabetic or received any antibiotics in last 3 months will be excluded from study. twenty patients (regardless of sex) will be included in this study. The base of this semisolid formulation will be used as placebo. The study will be designed in a bilateral form and the the metformin semisolid formulation will be applied on one side of the face and the placebo will be applied on the other side for three months. The number and severity of skin lesions (comedones, papules and pustules) will be counted and evaluated within the defined periods of the treatment (at the end of the first, second and third month of the treatment) which is expected to be decreased.
General information
Acronym
The effect of topical semisolid formulation of metformin on acne.
IRCT registration information
IRCT registration number:IRCT2017013132319N1
Registration date:2017-05-01, 1396/02/11
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-05-01, 1396/02/11
Registrant information
Name
Amir Azadi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3242 4128
Email address
aazadi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2018-09-21, 1397/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of therapeutic effect on severity and number of skin lesions, between metformin semisolid formulation and placebo, in patients with mild to moderate Acne vulgaris.
Public title
The effect of topical semisolid formulation of metformin on severity and number of skin lesions in acne patients.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Patients with mild to moderate acne, defined as a score of 1 to 30 on the global acne grading system (GAGS) scale, who did not get any treatment before, or were not satisfied with their previous acne therapies, will be participated in the study after giving written informed consent. Exclusion criteria: Patients will be excluded if they are diabetic or have an uncontrolled systemic disease; have received topical anti acne therapy two months before or during the study or any systemic therapy, 30 days before or during the study; were known to be allergic or sensitive to any of the study medications or their components; have a skin disease that might interfere with the diagnosis or evaluation of their skin lesions; pregnant women and lactating ones.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Shiraz- Imam Hossein square-Zand Avenue-The Central Building of Shiraz University of Medical Sciences-7th floor
City
Shiraz
Postal code
14336 - 71348
Approval date
2017-04-17, 1396/01/28
Ethics committee reference number
IR.SUMS.REC.1396.9
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
Skin lesions
Timepoint
0 , 4 , 8 weeks
Method of measurement
Observation
Secondary outcomes
1
Description
patients satisfaction
Timepoint
0,4,8 weeks
Method of measurement
determined by a 10 point scale ranging
Intervention groups
1
Description
The case group, will receive semisolid formulation of metformin, twice a day, for two months and Azithromycin 250mg caplet will be used every other day.
Category
Treatment - Drugs
2
Description
The control group will receive the base of semisolid formulation, the preparation will be administrated topically , two times in a day and for two months and Azithromycin 250mg caplet will be used every other day.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Faghihi Skin and Dermatology Clinic
Full name of responsible person
Dr Nasrin Saki
Street address
Shiraz-Iimam Hossein Square- Shahid Faghihi Hospital-Skin and Dermatology Clinic
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Seyed Basir Hashemi
Street address
Zand Ave. central building of Shiraz University of Medical Sciences
City
Shiraz
Grant name
طرح های تحقیقاتی دانشگاه علوم پزشکی شیراز
Grant code / Reference number
95-01-36-13955
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shahid Faghihi Skin and Dermatology Clinic- Shiraz-Iran
Full name of responsible person
Dr Nasrin Saki
Position
Assistant Professor of Dermatology at Shiraz University of Medical Sciences
Other areas of specialty/work
Street address
Imam Hossein square-Shahid Faghihi Hospital
City
Shiraz
Postal code
7134844119
Phone
+98 71 3235 1090
Fax
+98 71 3233 1634
Email
nasrinsa85@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences-Faculty of Pharmacy
Full name of responsible person
Dr Amir Azadi
Position
Assistant Professor of Pharmaceutics at Shiraz University of Medical Sciences
Other areas of specialty/work
Street address
Karafarin St- School of Pharmacy
City
Shiraz
Postal code
7146864685
Phone
+98 71 3242 4127
Fax
Email
aazadi@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences- Faculty of Pharmacy
Full name of responsible person
Dr Amir Azadi
Position
Assistant Professor of Pharmaceutics at Shiraz University of Medical Sciences
Other areas of specialty/work
Street address
Karafarin St- Pharmacy School
City
Shiraz
Postal code
714686468
Phone
+98 71 3242 4127
Fax
Email
aazadi@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)