1
Clinical Trial Protocol
Iranian Registry of Clinical Trials
05 Nov 2022
Vidara® cream and hydroderm anti stretch marks cream in prevention of striae gravidarum
Protocol summary
Summary
Striae gravidarum is observed among 50-90 percent of pregnant women and creates aesthetic concern among them. No final therapy has been determined for this because of its unknown etiology. In this study Vidara cream in prevention of these lines is compared with Hydroderm anti stretch marks cream. Nulliparous pregnant who refer to the executive's specialist office for prenatal visits, having the inclusion criteria and lack of exclusion criteria will be enrolled. People randomly assigned into two groups of 59-members receiving Vidara herbal cream or Hydroderm anti stretch marks cream,till from the week of 18-20 of their pregnancy massage their belly twice a day with a small amount of this cream. Both creams were prepared in the same package and both doctors and patients are unaware of the incoming cream. Patient follow-up visits are every 4 weeks until the end of pregnancy. Clinical evaluation of the abdomen is done by dividing it into 4 quadrant and the score of striae is determined by davey's score. Also striae colors specified through observation, itching by asking from patient, width and length of the biggest striae in each quadrant by measuring. By Using T tests and chi square; total score, length, diameter and color of striae is compared between two groups. Then with using ANOVA model and repeated measurements, effect of various factors on these parameters is determined.
General information
Acronym
IRCT registration information
IRCT registration number: IRCT2013021312438N2 Registration date: 2013-03-06, 1391/12/16 Registration timing: prospective
Last update:
Update count: 0
Registration date 2013-03-06, 1391/12/16 Registrant information
Name
Mohsen Taghizadeh
Name of organization / entity
Kashan University of Medical Sciences Country
Iran (Islamic Republic of) Phone
+98 36 1555 0021 Email address
taghizadeh_m@kaums.ac.ir Recruitment status
Recruitment complete Funding source
Barij Essence research center of medicinal herbs
Expected recruitment start date 2013-04-21, 1392/02/01
Expected recruitment end date 2014-04-21, 1393/02/01 Actual recruitment start date
empty
Actual recruitment end date empty
Trial completion date empty
Scientific title
Vidara® cream and hydroderm anti stretch marks cream in prevention of striae gravidarum
Public title
prevention of striae gravidarum Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: nulliparous, singleton
pregnancy,Healthy mothers between 18-40 years old and
2 16-20 week of pregnancy Exclusion criteria:Known
allergies to the components of Vidara cream and hydroderm, connective tissue disease . cellulites ,any illnesss ,injury and infection in the abdominal skin.
Age
From 18 years old to 40 years old Gender
Female Phase
1
Groups that have been masked No information
Sample size
Target sample size: 118
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
kashan university of medical sciences Street address
kashan university of medical science,kashan City
kashan Postal code
۸۷۱۵۹۸۸۱۴۱ Approval date
2011-07-27, 1390/05/05
Ethics committee reference number 9029
Health conditions studied
1
Description of health condition studied striae gravidarum
ICD-10 code L90.6
ICD-10 code description Striae atrophicae
Primary outcomes
1
Description number of striae Timepoint
since 16 weeks, every 4 weeks until the end of pregnancy
Method of measurement observation and counting
2
Description
largest striae width Timepoint
since 16 weeks, every 4 weeks until the end of pregnancy
Method of measurement
observation and measurement in milimeters
3
Description
largest striae lenght Timepoint
since 16 weeks, every 4 weeks until the end of pregnancy
Method of measurement
observation and measurment in centimeter
Secondary outcomes
1
Description itching Timepoint
from16 weeks until the end of pregnancy Method of measurement
asking from patient
Intervention groups
1
Description
in an intervention group women use of vidara cream twice a day and massage their abdomen softly,they start from 16th week, every 4 weeks until the end of
pregnancy Category
Treatment - Drugs
2
Description
in control group women use of Hydroderm anti streth cream twice a day and massage their abdomen
softly,,they start from 16th week, every 4 weeks until the end of pregnancy
3 Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center dr R.Talaee office
Full name of responsible person Street address
City kashan
2
Recruitment center
Name of recruitment center dr M.Samimi office
Full name of responsible person Street address
City kashan
3
Recruitment center
Name of recruitment center dr M.Jahangir office
Full name of responsible person Street address
City kashan
Sponsors / Funding sources
1 Sponsor
Name of organization / entity
Barij Essence research center of medicinal herbs Full name of responsible person
miss L.Hejazi Street address
km44 Kashan-Mashhad Ardehal road.
City Kashan Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Barij Essence research center of medicinal herbs 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
kashan university of medical sciences Full name of responsible person
M.Taghizadeh Position
phd
Other areas of specialty/work Street address
kashan university of medical sciences.kashan City
Kashan Postal code
۸۷۱۵۹۸۸۱۴۱ Phone
+98 36 1555 0021 Fax
taghizadeh_m@kaums.ac.ir Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
kashan university of medical sciences Full name of responsible person
R.Talaee Position
phd
Other areas of specialty/work Street address
kashan university of medical sciences.kashan City
Kashan Postal code
۸۷۱۵۹۸۸۱۴۱ Phone
+98 36 1555 0021 Fax
R_Talaee2007@yahoo.com Web page address
Person responsible for updating data
Contact
Name of organization / entity
Barij Essence research center of medicinal herbs Full name of responsible person
M.Mahlouji Position
Expert in clinical research Other areas of specialty/work
4 Street address
KM 44 Kashan-Mashhad Ardehal City
Kashan Postal code
3759111134 Phone
+98 86643621122113 Fax
mahnaz.mahlouji@yahoo.com Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD) empty
Study Protocol empty
Statistical Analysis Plan empty
Informed Consent Form empty
Clinical Study Report empty
Analytic Code empty Data Dictionary
empty
