Double blind Randomized Clinical trial of Comparison between Vaseline and Sterile Ophthalmic Vitamin A ointment effect, in treatment of Exfoliative Cheilitis in Girls Dormitory of Shahid Sadoughi University of Medical Sciences
Exfoliative cheilitis is an inflammatory condition which is accompanied by regular peeling of superficial keratin layer on lips. The unpleasant appearance and dryness of lips in this condition could be the cause of complaint and discontent in patients. The aim of this study was to compare the therapeutic effect of Vaseline with Sterile ophthalmic Vitamin A ointment in Exfoliative cheilitis treatment. In this clinical trial study, 30 female patients who had this lesion, from the Dormitory of Medical Sciences University, were selected and divided randomly and double-blinded into two groups of Vitamin A and Vaseline. The patients applied the drug topically, 3 times daily for 1 week as directed. Improvement of both groups, which include the severity and size of lesions were measured before drug usage and on the 2nd, 4th and 7th day after drug usage and the results were reported. Inclusion criteria include lack of systemic disease and non-consumption of drugs which make the skin dry. Exclusion criteria include non-cooperation while doing the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014052717879N1
Registration date:2014-07-07, 1393/04/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-07-07, 1393/04/16
Registrant information
Name
Zeynab Karimi
Name of organization / entity
Yazd, Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1823 5354
Email address
z.karimi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Yazd Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2013-06-30, 1392/04/09
Expected recruitment end date
2014-06-30, 1393/04/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Double blind Randomized Clinical trial of Comparison between Vaseline and Sterile Ophthalmic Vitamin A ointment effect, in treatment of Exfoliative Cheilitis in Girls Dormitory of Shahid Sadoughi University of Medical Sciences
Public title
Comparison of the therapeutic effect of Vaseline and Sterile ophthalmic Vitamin A ointment in treatment of Lip dryness
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: lack of systemic disease, non consumption of drugs which make the skin dry.
Exclusion criteria: non-cooperation while doing the study
Age
From 18 years old to 24 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Double blind means neither the researcher nor the patients know about the type of used drug in the accomplished study.
Randomization: using the random-number table, 30 participated patients in the study, were divided into two groups of 15.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yazd Shahid Sadoughi University of Medical Sciences
Street address
Central Department of Medical Sciences, Homafar St., Bahonar Sq.
City
Yazd
Postal code
Approval date
2013-07-13, 1392/04/22
Ethics committee reference number
17/1/71399/پ
Health conditions studied
1
Description of health condition studied
Exfoliative cheilitis
ICD-10 code
K13.0
ICD-10 code description
Diseases of lips
Primary outcomes
1
Description
Severity of lesion on the lip
Timepoint
Before drug usage, on the 2nd day, 4th day and 7th day after drug usage
Method of measurement
Quaternion ranking
2
Description
Size of lesion on the lip
Timepoint
Before drug usage, on the 2nd day, 4th day and 7th day after drug usage
Method of measurement
Transparent graph paper
Secondary outcomes
empty
Intervention groups
1
Description
Second intervention group: 34 gram tube containing medical Vaseline from Firooz Mfg.Co.Tehran- Iran for one week, three times daily.
Category
Treatment - Drugs
2
Description
First intervention group: Sterile ophthalmic Vitamin A with Xerovit trademark name and containing 250 IU/g Vit.A Palmitate in 5 gram aluminum tubes, made in Sina Darou Co. for one week, three times daily.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Girl’s dormitory of Yazd Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Zeynab Karimi
Street address
Daneshjoo Blvd., Imam Hosein Sq.
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Yazd Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Fateme Ezzodini
Street address
Central Department of Medical Sciences, Homafar St., Bahonar Sq.
City
Yazd
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 of Yazd Shahid Sadoughi 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
Yazd Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Zeynab Karimi
Position
Dental Student
Other areas of specialty/work
Street address
Central Department of Medical Sciences, Homafar St., Bahonar Sq.
City
Yazd
Postal code
Phone
+98 21 4466 0131
Fax
Email
z.karimi@ssu.ac.ir; zeynabkarimi2009@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Zeynab Karimi
Position
Dental Student
Other areas of specialty/work
Street address
Central Department of Medical Sciences, Homafar St., Bahonar Sq.
City
Yazd
Postal code
Phone
+98 21 4466 0131
Fax
Email
z.karimi@ssu.ac.ir; zeynabkarimi2009@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yazd Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Zeynab Karimi
Position
Dental Student
Other areas of specialty/work
Street address
Central Department of Medical Sciences, Homafar St., Bahonar Sq.
City
Yazd
Postal code
Phone
+98 21 4466 0131
Fax
Email
z.karimi@ssu.ac.ir; zeynabkarimi2009@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)