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Investigation of the effect of IPL with and without intradermal injection of tranexamic acid in treatment of resistant post acne Erythema , An split face control trial in loghman hakim hospital in 1401

Protocol summary

Study aim
To evaluate the effect of IPL laser with and without intradermal injection of tranexamic acid in post acne erythema.
Design
In this phase 3 clinical trial, a study is conducted on 25 patients with stable post-acne erythema. On one side of the face, the intervention is performed, and the other side of the face is considered as the control group, and to choose the intervention side, the randomization method is used by tossing a coin. It is possible to check the treatment response and compare the two sides of the face by a dermatologist who is unaware of the assignment of the facial area to receive tranexamic acid or placebo in a double-blind manner.
Settings and conduct
In this study, among the patients referred to Loqman Hakim Hospital, qualified individuals are selected by the researcher and referred to Bahar Clinic for intervention, where the intervention is performed by the researcher on one side of the face that the patient is unaware of.
Participants/Inclusion and exclusion criteria
People with persistent post acne erythema at least for 3 months in the age range of 16 to 40 years , whithout coagulation disorders ,cancers, sensitivity to drugs, drug intractions , pregnancy,breastfeeding,oral and topical use of retinoids ,tendency to create keloids , photo sensitivity ,use of topical exfoliating drugs.
Intervention groups
we have performed IPL laser on both sides of the face, , and on one side of the face, we have intra dermal injection of tranexamic acid , and on the other side, we have injection of normal saline as control group.
Main outcome variables
Examining the degree of improvement of acne indiuced - erythema by the dermatologist, the degree of patient satisfaction with the improvement of erythema on each side of the face, examination of side effects after laser and injection.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221206056736N1
Registration date: 2023-04-17, 1402/01/28
Registration timing: registered_while_recruiting

Last update: 2023-04-17, 1402/01/28
Update count: 0
Registration date
2023-04-17, 1402/01/28
Registrant information
Name
Nushin Golchin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4469 7518
Email address
nushin.golchin@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-04, 1401/11/15
Expected recruitment end date
2023-09-22, 1402/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of IPL with and without intradermal injection of tranexamic acid in treatment of resistant post acne Erythema , An split face control trial in loghman hakim hospital in 1401
Public title
effect of IPL with and without intradermal injection of tranexamic acid in treatment of post acne Erythema
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
people with persistent post acne erythema that did not improve for at least 3 months in the age range of 16 to 40 years
Exclusion criteria:
coagulation disorders such as DIC ,pulmonary embolism,stroke,DVT suffering from cancers sensitivity to tranexamic acid in previous use consumption of drugs that interfere with the use of tranexamic acid (anticoagulants,estrogenic drugs,tretinoin and anti inhibitory coagulation concentrates ) pregnancy,breastfeeding and the decision to become pregnant oral and topical use of retinoids in the last 6 months prone to keloid formation photosensitivity the use of exfoliating topical drugs including AHA
Age
From 16 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 25
More than 1 sample in each individual
Number of samples in each individual: 2
Intervention is done on one side of the face and the other side of the face is used as a control group
Randomization (investigator's opinion)
Randomized
Randomization description
Flip the coin, when the coin comes to the heads side , the right side of the face is intervened, and when the coin comes to the tails,the left side of the face is intervened.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient is unaware of the side of the intervention and examination of treatment response and comparison of two sides of the face by a dermatologist who is unaware of the assignment of the facial area to receive tranexamic acid or placebo.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid beheshti University of Medical Sciences
Street address
Shahid beheshti univerciyt,arabi Ave
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2022-11-09, 1401/08/18
Ethics committee reference number
IR.SBMU.SRC.REC.1401.012

Health conditions studied

1

Description of health condition studied
post acne erythema
ICD-10 code
L70.0
ICD-10 code description
Acne vulgaris

Primary outcomes

1

Description
Erythema improvment on the right and left side of the face
Timepoint
The beginning of the study, day 21, day 42, day 72
Method of measurement
Scale of Clinician erythema assessment

2

Description
Patient satisfaction from treatment on the right and left side compared to before
Timepoint
The beginning of the study, day 21, day 42, day 72
Method of measurement
Asking the patient to choose a number from 1 (low) to 4 (very high) ,from the level of satisfaction with the treatment on each side of face

Secondary outcomes

1

Description
The side effects
Timepoint
The beginning of the study, day 21, day 42, day 72
Method of measurement
Questions and comparisons

Intervention groups

1

Description
Intervention group: On the selected side of the face, ampoules of 500mg/5ml tranexamic acid will be injected intradermally by 1cc syringes at a distance of one centimeter in the areas with erythema caused by acne inflammation in the same session.
Category
Treatment - Drugs

2

Description
Control group: On the other side of the face, normal saline is injected intradermally by 1cc syringes at a distance of one centimeter in areas with erythema caused by acne inflammation in the same session.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Loghman Hakim hospital
Full name of responsible person
Nushin Golchin
Street address
Makhsos Ave,Loghman Hakim hospital
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5102 5000
Fax
+98 21 5541 7547
Email
Loghman.hospital@sbmu.ac.ir
Web page address
Https://Ihmc.sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Afshin Zarghi
Street address
Shahid Beheshti university,Arabi Ave,Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9780
Email
Info@sbmu.ac.ir
Web page address
Https://research.sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nushin Golchin
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No 2,West fahad Allay,Falsafi Ave, Ekbatan town
City
Tehran
Province
Tehran
Postal code
1393843673
Phone
+98 21 4469 7518
Email
Nushin.golchin@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nushin Golchin
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No 2,West fahad Allay,Falsafi Ave,Ekbatan town
City
Tehran
Province
Tehran
Postal code
1393843673
Phone
+98 21 4469 7518
Email
Nushin.golchin@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nushin Golchin
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No 2,west Farhad Allay,Falsafi Ave,Ekbatan town
City
Tehran
Province
Tehran
Postal code
1393843673
Phone
+98 21 4469 7518
Email
Nushin.golchin@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is shared after de-identifying people's faces and characteristics. Community Verified icon
When the data will become available and for how long
Since the publication of the results for one year
To whom data/document is available
Researchers
Under which criteria data/document could be used
In order to evaluate the obtained results, unidentifiable photos of the patients can be accessed.
From where data/document is obtainable
Go to Nushin Golchin's email address at Nushin.golchin@yahoo.com.
What processes are involved for a request to access data/document
Submit the application and submit valid documents, then check the applicant's profile and send the application file if eligible. Community Verified icon
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