Determining the effect of microneedling on the healing of striae alba lesions
Design
A non-randomized, no-blinding clinical trial, with the single group, Phase 2 on 34 patients
Settings and conduct
In this single-blind clinical trial study, 34 patients with striae alba lesions referred to the dermatology clinic of Al-Zahra Hospital in Isfahan will be included in the study. These patients will then undergo microneedling and the extent of scar healing will be assessed one and three months after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria include the existence of striae on the abdomen, buttocks, thighs, and sides in less than a year and not receiving any previous treatment for striae and skin types 3 and 4. Exclusion criteria included pregnancy, breastfeeding, the presence of striae alba on the chest and arms, previous treatment of striae with medication or laser, use topical or systemic steroids, Cushing's syndrome, use of isotretinoin or filler injection in the last 6 to 12 months, perform skin dermabrasion or laser skin resurfacing for the last 6 to 12 months at the striae site.
Intervention groups
Intervention group: First, local anesthesia is placed on the treatment site for half to one hour, then it is washed with normal saline and sterilized using the aseptic solution, and then it is treated with microneedling. Then the area is cleaned with sterile gas impregnated with normal saline and zinc oxide cream is applied to it. Patients are advised to refrain from washing the area for 24 hours and to apply zinc oxide on the site for at least 1 week and to avoid direct sunlight in a separate area.
Main outcome variables
Extent of scar healing
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200825048515N30
Registration date:2021-04-13, 1400/01/24
Registration timing:prospective
Last update:2021-04-13, 1400/01/24
Update count:0
Registration date
2021-04-13, 1400/01/24
Registrant information
Name
Asieh Maghami Mehr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 0000 0000
Email address
asimaghami@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-19, 1400/01/30
Expected recruitment end date
2021-06-20, 1400/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of microneedling on the healing of striae alba lesions
Public title
The effect of microneedling on the healing of striae alba lesions
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Existence of striae on the abdomen, buttocks, thighs and sides in less than a year
Not receiving any previous treatment for striae and skin types 3 and 4
Exclusion criteria:
Pregnancy
Breastfeeding
The presence of astriae alba on the chest and arms
Previous treatment of striae with medication or laser
Use topical or systemic steroids
Cushing's syndrome
Use of isotretinoin or filler injection in the last 6 to 12 months
Perform skin dermabrasion or laser skin resurfacing for the last 6 to 12 months at the striae site
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq
City
Isfahan
Province
Isfehan
Postal code
8179964167
Approval date
2021-01-10, 1399/10/21
Ethics committee reference number
IR.MUI.MED.REC.1399.908
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
Scar recovery rate
Timepoint
One month and three months after treatment
Method of measurement
Visual Analog Scale(VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: First, local anesthesia is placed on the treatment site for half to one hour, then it is washed with normal saline and sterilized using aseptic solution and then it is treated with microneedling. Then the area is cleaned with sterile gas impregnated with normal saline and zinc oxide cream is applied on it. Patients are advised to refrain from washing the area for 24 hours and to apply zinc oxide on the site for at least 1 week and to avoid direct sunlight in a separate area.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Amir Hossein Siadat
Street address
Department of Dermatology; Al-Zahra Hospital; Sofeh boulevard
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
dsiadat@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo Javanmard
Street address
Vice Chancellor for Research, School of Medicine, Hezar Jarib Street, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Email
dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Amir Hossein Siadat
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Department of Dermatology; Al-Zahra Hospital; Sofeh boulevard
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
dsiadat@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amir Hossein Siadat
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Department of Dermatology; Al-Zahra Hospital; Sofeh boulevard
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
dsiadat@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Reza Moeini Farsani
Position
Non-faculty physician
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Department of Dermatology; Al-Zahra Hospital; Sofeh boulevard
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
dsiadat@yahoo.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