The effect of Human Umbilical Cord Wharton's Jelly Stem Cell Conditioned Medium on treatment striae
Design
In this double-blind clinical trial, 10 patients with striae are included in the study and the abdominal striae area is divided into two equal parts and microneedling, one side of normal saline and the opposite side of medium conditioning is injected.
Settings and conduct
This study is performed in the center of Rasoul Akram Hospital in Tehran. All participants in this study will be blind to medium and normal saline condition. Physicians who study patient outcomes and collect and analyze information are blind to the two substances.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. Conscious consent to participate in this study. Approved striae. 3. Age over 18 and under 50.4. 4- Not receiving steroids and immunosuppressive drugs. 5- Not receiving striae treatment during the last 3 months. 6- No pregnancy and breastfeeding. 7- No collagen and vascular diseases; Exclusion criteria: 1- Using any treatment method to eliminate striae in the last three months. 2- Existence of skin lesions. 3- Existence of collagen and vascular patients. 4- Pregnancy and lactation. 5. Skin infection.
Intervention groups
In this study, Human Umbilical Cord Wharton's Jelly Stem Cell Conditioned Medium is intervention, and the intervention group is patients that suffer as striae. The control group is the same as the intervention group. In this way, the desired area is divided into two equal parts. Medium conditioning is not injected into the control part, but normal saline is injected.
Main outcome variables
Qualitative and quantitative intensity of striae
General information
Reason for update
Acronym
-
IRCT registration information
IRCT registration number:IRCT20211027052891N1
Registration date:2021-11-06, 1400/08/15
Registration timing:prospective
Last update:2021-11-06, 1400/08/15
Update count:0
Registration date
2021-11-06, 1400/08/15
Registrant information
Name
Masoumeh Feizollahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 1000
Email address
feizollahi_masoumeh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2022-06-21, 1401/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Human Umbilical Cord Wharton's Jelly Stem Cell Conditioned Medium on treatment striae: a double-blind clinical trial
Public title
The effect Stem Cell Conditioned Medium on treatment striae
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of striae based on the diagnosis of a dermatologist
Exclusion criteria:
Use any treatment to eliminate striae in the last three months
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
10
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and the evaluating physician will not know which side of the abdomen is injected with normal saline and conditioned medium
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Determine the depth of the Striae by photography with Visioface
2
Description
Adverse events
Timepoint
Before the intervention, 3 months after the last treatment session
Method of measurement
Patient report, physician diagnosis
3
Description
The rate of improvement in Striae
Timepoint
Before the intervention, 3 months after the last treatment session
Method of measurement
Global Aesthetic Improvement Scale (GAIS)
Intervention groups
1
Description
Intervention group: In this group, there are patients who suffer from striae. The patient is both the intervention group and the control group. In this case, the case area is divided into two equal parts, one area of the intervention group and the other area is considered as control.