The objective of this randomized double blind single centre clinical trial is to compare the effects of Doxycycline and Zinc sulfate in the treatment of acne. A total of 80 patients with acne who come to Sina hospital will be assigned into the following groups. The first group will receive doxycycline capsule, 1 00 mg, or 30 mg elemental zinc once daily. The patients in both groups will receive topical clindamycin 1%. Primary outcome is inflammatory and non inflammatory lesions and secondary outcome is total score of acne and disease treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105156493N1
Registration date:2011-06-30, 1390/04/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-06-30, 1390/04/09
Registrant information
Name
Effat Khodaeiani
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1334 3640
Email address
dr.khodaeiani@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2010-10-22, 1389/07/30
Expected recruitment end date
2011-10-22, 1390/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study of the clinical effectiveness of doxycycline capsule with zinc sulfate on the treatment of patients with acne vulgaris
Public title
The effect of doxycycline and zinc sulfate in acne
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 18-40 years old – mild to moderate acne – acne since more than 2 months ago
Exclusion criteria: severe and nodulocystic acne – pregnancy and breast feeding – other skin disease in face – use of systemic and topical steroids, lithium, B group vitamins, iodide or bromium, antibacterial soap and antiseptic soloutions, oral and topical antibiotics and zinc and systemic and topical anti acne drugs in recent 1 month and isotretinoin in recent 2 months and antiacid drugs and calcium and iron based agents
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Tabriz Univercity of Medical Sciences
Street address
Tabriz Univercity of Medical Sciences, Golgasht avenue, Tabriz.
City
Tabriz
Postal code
Approval date
2010-12-08, 1389/09/17
Ethics committee reference number
7333/4/5
Health conditions studied
1
Description of health condition studied
acne vulgaris
ICD-10 code
L70
ICD-10 code description
Disease of skin appendages
Primary outcomes
1
Description
Acne improvment
Timepoint
Before intervention, 4 Weeks later, 8 weeks later, 12 weeks later
Method of measurement
Counting of lesions (scoring)
Secondary outcomes
1
Description
Decrease of inflammatory and non inflammatory lesions
Timepoint
Before intervention, 4 weeks later, 8 weeks later, 12 weeks later
Method of measurement
Counting of lesions(scoring)
Intervention groups
1
Description
Control group: Doxycycline, 100mg, daily, for 12 weeks
Category
Treatment - Drugs
2
Description
Intervention group: Zinc sulphate, 30mg, daily for 12 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Yaghubi
Street address
Faculty of Medicine, Tabriz University of Medical sciences, Golgasht avenue, tabriz.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?