Evaluation of the efficacy, safety and reliability of the effect of microneedling with tranexamic acid, in combination with a hydroquinone topical formula, in comparison with any of the treatments alone in patients with melasma: A randomized controlled clinical trial
Evaluation of the efficacy and safety of the effect of microneedling with tranexamic acid, in combination with a hydroquinone topical formula, in comparison with any of the treatments alone in patients with melasma
Design
Clinical trial with two intervention groups, parallel, single-blind, randomized, phase 2-3 on 50patients, randomized with randomization list prepared by the statistics specialist with specialized software.
Settings and conduct
Group A: Patients use the Kligman-like topical formula on one side of the face every other day for 2 months and microneedling with 10% tranhexamic acid on the other side for 3 sessions at intervals of 1 month. Group B: Patients use the Kligman-like topical formula for both sides of the face and in addition, on one side of the face, microneedling with tranhexamic acid 10% and on the opposite side microneedling with tranhexamic acid 4%.The second physician and statistics specialist are blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 18 to 60 years old, Clinical diagnosis of bilateral melasma of the cheek
Exclusion criteria: Patients who have received any treatment for melasma in the past 1 month. Contraindications to tranexamic acid. Mental instability. Patients who do not have informed consent to participate in the study. Patients who do not have the opportunity to visit regularly and cooperate for scoring and follow-up sessions
Intervention groups
Group A: Patients use the Kligman-like topical formula on one side of the face and microneedling with 10% tranhexamic acid on the other side. Group B: Patients use the Kligman-like topical formula for both sides of the face and in addition, on one side of the face, microneedling with tranhexamic acid 10% and on the opposite side microneedling with tranhexamic acid 4%.
Main outcome variables
Efficacy by modified Melasma Area & Severity Index and Visual Analogue Scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220122053789N1
Registration date:2022-02-13, 1400/11/24
Registration timing:prospective
Last update:2022-02-13, 1400/11/24
Update count:0
Registration date
2022-02-13, 1400/11/24
Registrant information
Name
Saba Baybordi Aghdam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2390
Email address
baybordi.s@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-16, 1400/12/25
Expected recruitment end date
2023-03-16, 1401/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy, safety and reliability of the effect of microneedling with tranexamic acid, in combination with a hydroquinone topical formula, in comparison with any of the treatments alone in patients with melasma: A randomized controlled clinical trial
Public title
Evaluation of the effect of microneedling with tranexamic acid in combination with hydroquinone formula in comparison with either alone in the treatment of melasma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 60 years old
Clinical diagnosis of bilateral melasma of the cheek
Exclusion criteria:
Patients who have received any treatment for melasma in the past 1 month.
Patients who have contraindications to tranexamic acid. (Includes known drug allergy, intracranial hemorrhage, known color vision disorder, history of arterial or venous thromboembolism or active thromboembolic disease, ischemic heart disease, and stroke)
Patients with mental instability (which is expected to affect the study process).
Patients who do not have informed consent to participate in the study.
Patients who do not have the opportunity to visit regularly and cooperate for scoring and follow-up sessions.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly divided into one of two groups A or B with an equal number by the randomization list prepared by the statistics specialist with specialized software. Each patient who have the inclusion criteria will be randomly admitted to one of the two treatment groups according to the randomization list. To choose which side of the face to be assigned to which of the two desired treatments, a simple random method will be performed by the doctor at the same time.
Blinding (investigator's opinion)
Single blinded
Blinding description
The second physician and statistics specialist are blind to the group in which each patient is located and the type of treatment performed on each side of the patient's face.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of medical scinces
One and two months after the start of treatment and one and four months after the end of treatment
Method of measurement
By modified Melasma Area & Severity Index and Visual Analogue Scale
Secondary outcomes
1
Description
Safety
Timepoint
One and two months after the start of treatment and one and four months after the end of treatment
Method of measurement
Ask from the patient for possible adverse effects
2
Description
Satisfaction
Timepoint
One and two months after the start of treatment and one and four months after the end of treatment
Method of measurement
Based on patient scoring
Intervention groups
1
Description
Intervention group A: Patients use the Kligman-like topical formula on one side of the face every other day for 2 months and microneedling with 10% tranhexamic acid on the other side for 3 sessions at intervals of 1 month.
Category
Treatment - Other
2
Description
Intervention group B: Patients use the Kligman-like topical formula for both sides of the face every other day for 2 months and in addition, on one side of the face, microneedling with tranhexamic acid 10% and on the opposite side microneedling with tranhexamic acid 4% for 3 sessions at intervals of 1 month.