Evaluation of efficacy and safety of microneedling and phenytoin cream 1% compared to microneedling in atrophic scars caused by facial acne: a double-blind randomized clinical trial
Evaluation of efficacy and safety of microneedling and phenytoin cream 1% in comparison with microneedling in atrophic scars caused by facial acne
Design
Double- blind clinical trail, randomized, phase 3 on 25 patients, randomized with sealed envelope.
Settings and conduct
This study is performed in the center of Rasoul Akram Hospital in Tehran. All participants in this study will be blind. Physicians who monitor patient outcomes and collect and analyze information are also blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1- Patients with atrophic facial acne scars aged 18-45 years
2-Patients with skin type 1-4
Exclusion criteria:
1) Sensitivity to phenytoin
2) Patients who have received laser treatment in the last three months.
3) Patients with active colloidal scar or active pigmented lesion at the injection site.
4) History of malignancy or receiving chemotherapy
Intervention groups
In this study, the intervention group is patients with atrophic scar lesion. The control group is the same as the intervention group. In each patient, one side of the face receives microneedling and phenytoin cream, which is considered the intervention group, and on the opposite side of the face, only microneedling is performed, which is considered as the control group
Main outcome variables
Qualitative and quantitative severity of atrophic scars
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211108052997N1
Registration date:2021-12-18, 1400/09/27
Registration timing:prospective
Last update:2021-12-18, 1400/09/27
Update count:0
Registration date
2021-12-18, 1400/09/27
Registrant information
Name
Arezoo Pashaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8827 0942
Email address
Pashaei.arezoo8799@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-31, 1400/10/10
Expected recruitment end date
2022-07-01, 1401/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of efficacy and safety of microneedling and phenytoin cream 1% compared to microneedling in atrophic scars caused by facial acne: a double-blind randomized clinical trial
Public title
Evaluation of the effect of microneedling and phenytoin cream on atrophic scars compared to microneedling
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with atrophic facial acne scars aged 18-45 years
Patients with skin type 1-4
Exclusion criteria:
Sensitivity to phenytoin.
Patients who have received laser treatment in the last three months.
Patients with active colloidal scar or active skin lesion at the injection site.
History of malignancy or receiving chemotherapy.
Age
From 18 years old to 45 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
25
More than 1 sample in each individual
Number of samples in each individual:
2
Each patient is considered both control group and intervention group. One side of the face is the control group and the opposite side is the intervention group.
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method is random among patients referred to Hazrat Rasool Akram Hospital. The randomization method is simple. Our tool is to randomize the table of random numbers and place them inside sealed bags. Each bag contains the letters A or B:
A: for the group receiving microneedling and phenytoin cream on the right and only microneedling on the left side of the face.
B: for the group receiving microneedling and phenytoin cream on the left and only microneedling on the right side of the face.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient and 2 evaluating dermatologists will be blinde to which side of the face received microneedling and phenytoin. Also, they will not know which side of the face is the only microneedling done..
Placebo
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 Sciences
1-At the beginning of the study, 2- before the second turn 3- before the third turn. 4. Two months after the end of the treatment period
Method of measurement
Photography by visioface. Objective observation.Visioface a full face photographic method for facial skin analysis. It has an accurate software to take high resolution full face photos and allows faster image capture with automatic skin type classification. By processing these images, skin problems are identified.
Secondary outcomes
1
Description
Quantative intensity of atrophic scars
Timepoint
1) At the beginning of the study. 2) Before the second turn 3) Before the third turn. 4) Two months after the end of the treatment period.
Method of measurement
Determine the depth of the scar by shooting by visioface,Scoring with Baron and Goodman scale
2
Description
Adverse events
Timepoint
1) At the beginning of the study. 2) Before the second turn 3) Before the third turn. 4) Two months after the end of the treatment period.
Method of measurement
Patient report, physician diagnosis
3
Description
The rate of improvement of scar
Timepoint
1) At the beginning of the study. 2) Before the second turn 3) Before the third turn. 4) Two months after the end of the treatment period.
Method of measurement
Patient satisfaction, photography by visioface, physician diagnosis
Intervention groups
1
Description
Intervention group: The intervention group is patients suffering from Atrophic scar lesion. The intervention group will be treated with microneedling and 1% Phenytoin topical cream, made by Medifarm company, three times a day for a week. The number of microneedling sessions will be monthly for three months (with an interval of one month and three times). Nysoya machine and 36 needle cartridges will be used for microneedling. The speed of the microneedling device will be set at 100 Hz and the penetration depth of the needles will initially be half a millimeter.Then the depth of penetration of the needles will gradually increase until there is a bleeding pinpoint on the skin. The handpiece will be done perpendicular to the skin as well as horizontally and rotationally, and spot bleeding during microneedling will be cleared with normal sterile saline. Local anesthesia using Xylopi topical cream will be performed one hour before the intervention on patients. After the intervention, the face will be washed with normal saline.
Category
Treatment - Other
2
Description
Control group: All steps performed for the intervention group will be repeated for the control group, except that the control group will be treated wit microneedling and Mupirocin cream only three times a day as a placebo for one week. It should be noted that each patient is considered both control group and intervention group. One side of the patient's face will be the control group and the opposite side will be the intervention group.