Determining the effectiveness of microneedling alone compared to microneedling combined with mesotherapy in the treatment of acne scars
Design
Clinical trial, with parallel groups, single-blind, simple randomization, phase 4
is conducted on 20 patients referred to skin clinics of BooAli Hospital in Tehran in 2023
Settings and conduct
The study subjects will be selected from among the patients with acne scars referred to the skin clinics of Bo Ali Hospital in 2023 who meet the inclusion criteria so that the sample size reaches the desired number. Then the patients are divided into two simple random one-sided groups, which are matched with each other in terms of age and gender.
Participants/Inclusion and exclusion criteria
The conditions for entering the study include all patients aged 18 to 55 years with acne scars who have signed the informed consent form to participate in the study.
Exclusion criteria include:
- pregnancy
- Topical or oral retinoid use
- Use of facial beauty skin methods including laser in the last 6 months
- History of bleeding disorders
- Simultaneous antithrombotic treatment
- History of keloid scars
- People with a history of drug sensitivity
Intervention groups
Intervention group one: In this group, patients are treated with microneedling alone.
Intervention group two: In this group, patients are treated with microneedling and mesotherapy.
Main outcome variables
reducing hyperpigmentation; Reduction of hypertrophy or atrophy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230601058357N1
Registration date:2023-06-08, 1402/03/18
Registration timing:prospective
Last update:2023-06-08, 1402/03/18
Update count:0
Registration date
2023-06-08, 1402/03/18
Registrant information
Name
Hengameh Sarnaz
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2200 6660
Email address
hengame.sarnaz@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-15, 1402/03/25
Expected recruitment end date
2023-09-16, 1402/06/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of microneedling alone with microneedling combined with mesotherapy in the treatment of acne scars
Public title
Investigating the effect of microneedling and mesotherapy in the treatment of acne scars
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 to 55 years
Informed consent to participate in the study
Exclusion criteria:
pregnancy
Topical or oral retinoid use
Using facial beauty skin procedures including laser in the last 6 months
History of bleeding disorders
Concomitant antithrombotic treatment
History of keloid scars
Patients with a history of drug sensitivity
Age
From 18 years old to 55 years old
Gender
Both
Phase
4
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
The table of random numbers is prepared and by placing a hand on a number randomly and moving the hand in one of the predetermined directions, each person is given a number. People who have even numbers in will be in intervention group A and individual numbers will be in the group Intervention B.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants in both groups remain unaware of the treatment method allocation during the study. The patient is informed that there are two types of treatment methods in a study and they will receive one of them randomly. Patients remain unaware of the name of the treatment method assigned to them.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Tehran Islamic Azad University Of Medical Sciences
Street address
Tehran Islamic Azad University of Medical Sciences, Khaghani St, Shariati Ave
City
Tehran
Province
Tehran
Postal code
19499160112
Approval date
2022-09-19, 1401/06/28
Ethics committee reference number
IR.IAU.TMU.REC.1401.224
Health conditions studied
1
Description of health condition studied
skin scar
ICD-10 code
L90.5
ICD-10 code description
Scar conditions and fibrosis of skin
2
Description of health condition studied
Acne
ICD-10 code
L70.9
ICD-10 code description
Acne, unspecified
Primary outcomes
1
Description
Determining the comparison of the effect of microneedling along with mesotherapy and microneedling alone on the treatment of acne scars
Timepoint
Three months after the intervention
Method of measurement
The opinion of two dermatologist separately
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with acne scars are treated with microneedling along with mesotherapy
Category
Treatment - Other
2
Description
Intervention group: Patients with acne scars are treated by microneedling alone.