Comparision of the effectiveness of platelet-rich plasma (PRP) and tranexamic acid + vitamne C mesotherapy in the treatment of periorbital hyperpigmentation (POH)
Comparision of the effectiveness of PRP and tranexamic acid + vitamin C mesotherapy in the treatment of periorbital hyperpigmentation
Design
Randomized clinical trial with control group and parallel group, double-blind, with 20 participants, for randomization we used the random numbers table.
Settings and conduct
This is a double-blind randomized controled trial, 20 male or female participants with minimum age of 18 with diagnosed periorbital hyperpigmentation attending dermatology clinic in Afzalipour hospital in kerman enroll the study. intervention and control groups will be selected accidentally, intervention group will recieve mesotherapy with tranexamic acid & vitamin C, control group will recieve PRP injection. participants and evaluator of the treatment response are blind in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria :
- Diagnosis of non-structural POH by dermatologist in Afzalipour hospital dermatology clinic
- Filling the written letter of satisfaction to participate in the project
- Minimum age of 18 when filling the letter of satisfaction
- Male or non-pregnant, non-breast feeding female gender
Exclusion criteria :
- Pregnancy and lactation
- Age under 18 and above 65 years old
- Smoking
- Previous or current bleeding disorders
- Using anti coagulant medications
- Presence of any active lesion in the treatment area
Intervention groups
Intervention group A will recieve mesotherapy with tranexamic acid & vitamin C in 3 sessions with 3 week intervals, and in control group B PRP injection will be done in 3 sessions with 3 week intervals.
Main outcome variables
Degree of pigmentation, improvement scale, patient satisfaction scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200623047891N2
Registration date:2022-08-21, 1401/05/30
Registration timing:retrospective
Last update:2022-08-21, 1401/05/30
Update count:0
Registration date
2022-08-21, 1401/05/30
Registrant information
Name
Najme sadat Hashemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3226 3162
Email address
njs.hashemi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparision of the effectiveness of platelet-rich plasma (PRP) and tranexamic acid + vitamne C mesotherapy in the treatment of periorbital hyperpigmentation (POH)
Public title
Assessing effectiveness of PRP and tranexamic acid + vitamne C mesotherapy in the treatment of periorbital dark circle
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of non-structural POH by dermatologist in Afzalipour hospital dermatology clinic
Filling the written letter of satisfaction to participate in the project
Minimum age of 18 when filling the letter of satisfaction
Male or non-pregnant, non-breast feeding female gender
Exclusion criteria:
Smoking
Previous or current bleeding disorders
Using anti coagulant medications
Presence of any active lesion in the treatment area
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
20 participants will participate in this trial. because there is right and left side fore the face of each participant, there is 40 areas for treatment. we allocate the letter R to the right side of each participant and the letter L to the left side.
Then we organize the letters R & L from number 1 t0 40 (i.e RLRLRL...RL).
One row and one column will be randomly chosen from the table of random numbers; the intersection between this row and column will be the starting point for sampling. A finger will be put on the starting point and will be moved downwards through the table. Because there should be 20 areas in the intervention group A (tranexamic acid & vitamin C) and 20 areas in the control group B (PRP) , the two digits at the right side of each number in the table will be considered. The moving of finger will be repeated until 20 areas of the intervention group A will be chosen. Duplicate numbers and numbers larger than 40 will not be considered. In this way, it will be found out that which 20 numbers among all of the 40 numbers given to the whole areas will be allocated to the intervention group A (e.g. numbers 3, 4, 9, 11, 13, 14, ...). The remaining 20 areas will be automatically put in the control group B.
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double-blind study. Blinding was done in two levels: The first level: the dermatologist examining the effectiveness rate on each side of the treated face, who was different from the main dermatologist directing the study, and was not aware of the type of treatment performed on each side of the face.
second level: data analyzer, who was not given information about the type of treatment performed on each side of the face and their possible effectiveness.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Ebne Sina Ave, Tahmasb Abad Blvd
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2020-11-08, 1399/08/18
Ethics committee reference number
IR.KMU.AH.REC.1399.105
Health conditions studied
1
Description of health condition studied
Periorbital hyperpigmentation
ICD-10 code
L81.4
ICD-10 code description
Other melanin hyperpigmentation
Primary outcomes
1
Description
Severity of periorbital hyperpigmentation
Timepoint
At the begining of the study (before intervention) and 1 and 3 months after intervention
Method of measurement
Using Patient and Physician Global Assessment score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intra dermal injection of 0.5cc tranexamic acid and 0.5cc vitamin C into the infraorbital region in 3 session with 3-week intervals.(at the beginning of the study, general explanations about how to perform the work and after care were provided to all volunteer patients participating in the study. 0.5cc of 5cc ampoules of tranexamic acid from Caspian Tamin Iran Company along with 0.5cc of a 5cc ampoule of Vitamin C from Elixir Company was mixed in a 1cc BD syringe and injected intradermally into the dark areas around the eyes at an angle of 15-30 degrees (the desired points at a distance of 0.5-1cm) considered and 0.1cc was injected at each point).This treatment was done for three sessions, with an interval of three weeks.
Category
Treatment - Drugs
2
Description
Control group: Intra dermal injection of 1cc platelet rich plasma into the infraorbital region in 3 session with 3-week intervals. (At first, general explanations about how to perform the work and after care were given to all volunteer patients participating in the study. 5 cc of blood was taken from each patient. Then the sample was centrifuged at 1500 revolutions per minute for ten minutes. It was centrifuged. The clear plasma placed on the surface was separated and 1 cc of it was transferred to a 1 cc BD syringe. The injection was done at an angle of 15-30 degrees, intradermally to the dark areas around the eyes. (The desired points were considered with a distance of 0.5-1cm and 0.1cc was injected at each point). This treatment was done for three sessions, three weeks apart.)