Comparison of topical application of a combination of vitamin C, E and moisturizing ingredients, ultrasound and phonophoresis on the striae distensae in healthy young women
The objective of this randomized trial is to investigate the effect of topical application of a combination of vitamin C, E and moisturizing ingredients, ultrasound and phonophoresis on the striae distensae in healthy young women . In this study 40 women who meet the inclusion/exclusion criteria will be recruited and randomly assigned into one of the 3 intervention or control groups. All Striaes will be selected from abdominal area. The subjects in the intervention group 1 will receive ultrasound with ultrasounic gel. The subjects in the intervention group 2 will receive ultrasound through phonophoresis of a combination of vitamin C, E and moisturizing ingredients. The subjects in the intervention group 3 will receive topical application of a combination of vitamin C, E and moisturizing ingredients .The subjects in control group will receive placebo ultrasound. Intervention lasts for30 sessions. Length, width and quality of striaes of all participants will be measured before intervention, immediately after and 1 month after the intervention, and will be compared among 4 groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201207204203N6
Registration date:2012-08-04, 1391/05/14
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-08-04, 1391/05/14
Registrant information
Name
Atefeh Aminian Far
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 1335 4180
Email address
aminianfar@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research, Semnan University of Medical Sciences (Governmental source)
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2013-03-19, 1391/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of topical application of a combination of vitamin C, E and moisturizing ingredients, ultrasound and phonophoresis on the striae distensae in healthy young women
Public title
Striae and Phonophoresis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Aged between 17-35years old, striae aged less then 6 months, written consent, sex female.
Exclusion criteria: Previous history of disease like cushing syndrome, history of corticosteroid injection, skin disease, abrupt weight gain/loss, presence of any type of medication for striae like drug or cream.
Age
From 17 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Deputy of Research, Semnan University of Medical Sciences
Street address
Bassij Blvd, Semnan University of Medical Sciences, Deputy of Research, Semnan, Iran.
City
Semnan
Postal code
3519899951
Approval date
2012-06-12, 1391/03/23
Ethics committee reference number
91/186148
Health conditions studied
1
Description of health condition studied
Atrophic disorders of skin
ICD-10 code
L90.6
ICD-10 code description
Striae atrophicae
Primary outcomes
1
Description
Length of Striae
Timepoint
Before Intervention, following 30 sessions of intervention, 1 month following end of intervention
Method of measurement
through caliper
2
Description
Width of Striae
Timepoint
Before Intervention, following 30 sessions of intervention, 1 month following end of intervention
Method of measurement
through caliper
3
Description
Intensity of Striae
Timepoint
Before Intervention, following 30 sessions of intervention, 1 month following end of intervention
Method of measurement
Based on computerized software and digitalized photography
4
Description
Color of Striae
Timepoint
Before Intervention, following 30 sessions of intervention, 1 month following end of intervention
Method of measurement
Based on computerized software and digitalized photography
5
Description
Hue of Striae
Timepoint
Before Intervention, following 30 sessions of intervention, 1 month following end of intervention
Method of measurement
Based on computerized software and digitalized photography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention (3): Just topical application of a combination of vitamin C, E and moisturizing ingredients on striae. This intervention lasts for 30 days/ daily.
Category
Treatment - Drugs
2
Description
Control: Placebo ultrasound for 5 minutes. . This intervention lasts for 30 days/ daily.
Category
Treatment - Drugs
3
Description
Intervention (1): using ultrasound 3MHz, pulsative (20%), low intensity 0.8 W/cm2, increasing gradually through sessions, for 5 minutes on abdominal striae . This intervention lasts for 30 days/ daily.
Category
Treatment - Other
4
Description
Intervention (2): Phonophoresis of a combination of vitamin C, E and moisturizing ingredients using ultrasound 3MHz, pulsative (20%), low intensity 0.8 W/cm2, increasing gradually through sessions, for 5 minutes on abdominal striae. Amount of vitamin C: 20%, vitamin E: 1% and moisturizers: 10%. this ingredients would be combined with ultrasonic gel in proportion of 50-50. This intervention lasts for 30 days/ daily.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinics under supervision of Semnan University of Medical Sciences
Full name of responsible person
Dr. Atefeh Aminian Far
Street address
Kilometer 5 Damghan road, Semnan University of Medical Sciences
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research, Semnan University of Medical Sciences
Full name of responsible person
Dr. Raheb Ghrbani
Street address
Bassij Blvd, Semnan University of Medical Sciences, Deputy of Research, Semnan, Iran.
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research, Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Dr. Atefeh Aminian Far
Position
Ph.D of Physiotherapy/ Assistant Professor
Other areas of specialty/work
Street address
Kilometer 5 Damghan road, Semnan University of Medical Sciences
City
Semnan
Postal code
1439957181
Phone
+98 23 1335 4182
Fax
Email
aminfar@sem-ums.ac.iraminfar83@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Atefeh Aminian Far
Position
Ph.D of Physiotherapy/ Assistant Professor
Other areas of specialty/work
Street address
Kilometer 5 Damghan road, Semnan University of Medical Sciences
City
Semnan
Postal code
1439957181
Phone
+98 23 1335 4182
Fax
Email
aminfar@sem-ums.ac.iraminfar83@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Atefeh Aminian Far
Position
Ph.D of Physiotherapy/ Assistant Professor
Other areas of specialty/work
Street address
Kilometer 5 Damghan road, Semnan University of Medical Sciences
City
Semnan
Postal code
1439957181
Phone
+98 23 1335 4182
Fax
Email
aminfar@sem-ums.ac.iraminfar83@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)