comparison between the efficacy of carboxytherapy vs microderm abrasion in the treatment of striae alba in womans referring to Afzalipour Hospital Dermatology Clinic
Comparison between efficacy of carboxy therapy vs microderm abrasion in treatmentof striae alba
Design
Non randomised, parallel group trial with blinded outcome assessment and with sample size consisting of 15 patients
Settings and conduct
The study involved 15 women aged 18 -45 who have come to the dermatology clinic for treatment of striae alba. The site of this study is Afzali Hospital Dermatology Clinic. Each person undergoes carboxytherapy for their right side and microderm abrasion for the left side .
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women aged 18 to 45 years, have striae leisions.
Exclusion criteria: History of keloid formation ; pregnancy; lactation ; The presence of infection in the intervention site ;Recent consumption of oral steroid , oral retinoid, immunosuppressive drugs ; The presence of systemic disease ; History of treatment of the striae in the last 6 months
Intervention groups
every patient receive treatment in the form of carboxy therapy in their right side and microderm abrasion in their left side every 2 week for 4 session
Main outcome variables
efficacy of treatment (decrease latitude and width of lesion,the color of the waste is similar to the natural skin color), patient satisfaction, side effects of treatment ,skin biopsy changes(increase of elastic fibers in dermis)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180621040173N1
Registration date:2018-10-31, 1397/08/09
Registration timing:registered_while_recruiting
Last update:2018-10-31, 1397/08/09
Update count:0
Registration date
2018-10-31, 1397/08/09
Registrant information
Name
Mehri Shahsavari pour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3323 2035
Email address
m.shahsavari@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-23, 1397/08/01
Expected recruitment end date
2018-12-22, 1397/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison between the efficacy of carboxytherapy vs microderm abrasion in the treatment of striae alba in womans referring to Afzalipour Hospital Dermatology Clinic
Public title
comparison between the efficacy of carboxytherapy vs microderm abrasion in treatment of striae alba
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All Women 18 to 45 years who have striae alba
Exclusion criteria:
the previous history of keloids
pregnancy
lactation
if there is a skin infection at the site
recent taking oral steroid , oral retinoid, immunosuppressive drugs
at the same time there is a systemic disease
treatment of striae in the last 6 months
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
15
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The dermatologist who evaluates the outcome of striae treatments is blind to the type of intervention performed on each side of the pationts body
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
EmamKhomeini High way, Afzalipour hospital
City
Kerman
Province
Kerman
Postal code
7616913911
Approval date
2018-10-10, 1397/07/18
Ethics committee reference number
IR.KMU.REC.1397.236
Health conditions studied
1
Description of health condition studied
striae alba
ICD-10 code
L90.6
ICD-10 code description
Striae atrophicae
Primary outcomes
1
Description
Recovery percentage of striae alba
Timepoint
before treatment and a month after last treatment
Method of measurement
observation and ruler which is measured by the quartile grading system
2
Description
side effects include erythema , bruising , pigmentation
Timepoint
two weeks after each procedure
Method of measurement
observation
3
Description
skin biopsy changes as increase elastic fibers in dermis
Timepoint
one month after the last treatment
Method of measurement
ellastin staining
Secondary outcomes
1
Description
patient satisfaction
Timepoint
before treatment and a month after last treatment
Method of measurement
patient observation and questionnaire
Intervention groups
1
Description
ntervention group: every patient receive treatment in the form of carboxy therapy in their right side every 2 week for 4 session. Skin biopsies are taken before and after treatment in 3 patients
Category
Treatment - Devices
2
Description
Control group: every patient receive treatment in the form of microderm abrasion in their left side every 2 week for 4 session. Skin biopsies are taken before and after treatment in 3 patients
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
dermatology clinic in Afzalipour hospital
Full name of responsible person
Mehri Shahsavari Pour
Street address
Imam Khomeini high way
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3132 8000
Email
m.shahsavari@kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhti
Street address
Ibn Sina Ave
City
Kerman
Province
Kerman
Postal code
1355576169
Phone
+98 34 3226 3719
Email
abpardakhty@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mehri Shahsavari pour
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
dermatology
Street address
54, Mostafa Khomeini Ave
City
Kerman
Province
Kerman
Postal code
7617658687
Phone
+98 34 3323 2035
Email
mshahsavari@kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mehri Shahsavari Pour
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Others
Street address
54, Mostafa Khomeini Ave
City
Kerman
Province
Kerman
Postal code
7617658687
Phone
+98 34 3323 2035
Email
mshahsavari@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mehri Shahsavari Pour
Position
Dermatology resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Shahab street, 54 Ave
City
Kerman
Province
Kerman
Postal code
7617658689
Phone
+98 34 3323 2035
Fax
Email
Mehr.shpour@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD