Determining the Effectiveness of Tranxamic Acid ampules as Mesotherapy in improving Persistent Erythema caused by Inflammatory Acne
Design
A clinical trial with a control group is performed on 30 patients
Settings and conduct
One side of each patient's face is considered for control and the other side of the patient's face is considered as a observe and the two sides of the patient's face are compared during the treatment period and one month after the completion of treatment. On the right side of each patient's face, Transaxamic Acid is injected Intradermally into the intradermal area at a distance of one centimeter in the amount of 0.1 cc as Mesotherapy (Tranexamic Acid ampoules are used by injection in cc syringes). Be On the left side of the same patient's face, No medicine is injected and is considered as a control. The second and then one month after the last visit are photographed and compared with the help of Delta scale in a quantitative and qualitative way. And then compared.
Participants/Inclusion and exclusion criteria
Patients with persistent post acne erythema on the face.
Inclusion criteria were individuals with persistent post acne erythema (3 months after acne recovery) and no age limit. Exclusion criteria include a history of critical disorders such as DIC, Pulmonary Embolism, Stroke, and DVT, as well as cancers and Drug Allergies in previous use, Pregnancy, and Lactation, or deciding to become pregnant and using medications with Tranxamic Acid intake interferes with patients who have been treated orally and topically with Tretinoid drugs now or over the past month.
Intervention groups
Patients with Persistent Post Acne Erythema on the face.
Main outcome variables
Persistent Post Acne Erythema
per two weeks
with Visioface
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190901044666N1
Registration date:2020-09-03, 1399/06/13
Registration timing:registered_while_recruiting
Last update:2020-09-03, 1399/06/13
Update count:0
Registration date
2020-09-03, 1399/06/13
Registrant information
Name
Afsaneh Sadeghzadeh bazargan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2421
Email address
sadeghzadeh.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-31, 1399/06/10
Expected recruitment end date
2020-09-05, 1399/06/15
Actual recruitment start date
2020-08-31, 1399/06/10
Actual recruitment end date
2020-09-05, 1399/06/15
Trial completion date
2020-11-05, 1399/08/15
Scientific title
Evaluation the Effect of Tranexamic Acid by Mesotherapy on Persistant Post Acne Erythematous
Public title
Evaluation the Effect of Tranexamic Acid by Mesotherapy on Persistant Post Acne Erythematous
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with Post Acne Erythema at face
Exclusion criteria:
Coagulopathy like DIC , Pulmonary Emboli , CVA , DVT,Malignancies,Drug reaction with Tranexamic Acid,Drug Interaction with Tranexamic Acid,Pregnancy , Feeding , Plan to Pregnancy
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
20
Randomization (investigator's opinion)
N/A
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 Iran University of Medical Sciences
Street address
39, 7 Ave., Kaj Sq., Saadat Abad Ave.,Tehran
City
Tehran
Province
Tehran
Postal code
19988718444
Approval date
2020-08-31, 1399/06/10
Ethics committee reference number
IR.IUMS.REC.1399.496
Health conditions studied
1
Description of health condition studied
Persistent Post Acne Erythema
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Persistent Post Acne Erythema
Timepoint
First visit, Two weeks after the first visit, One month after the second visit
Method of measurement
By Visioface
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this study, one side of each patient's face is considered as a control and the other side of the patient's face is considered as a observe, and the two sides of the patient's face are compared during the treatment period and one month after the completion of treatment. On the right side of each patient's face tranexamic acid as mesotherapy (Tranexamic Acid ampoules by one cc syringes used for injection) in the area with erythema due to acne inflammation intradermally at intervals of one centimeter in the amount of 0.1 cc Is injected. On the left side of the same patient's face, no medicine is injected and is considered as a observe. The second and then one month after the last visit are photographed and compared with the help of Delta scale in a quantitative and qualitative way. And then compared.