Comparative efficacy study of microneedling (2 different depth of penetration) and topical minoxidil versus topical minoxidil alone in androgenetic alopecia in patients referring to educational center of Isfahan university of medical sciences
To assess the efficacy of combined microneedling ( with two different depth of penetration) and topical minoxidil in the treatment of moderate to severe androgenetic alopecia (AGA) compared with topical minoxidil alone
Design
Randomized, double-blind, parallel group clinical trial of sixty patients with one control group and two intervention groups. Randomization is attained using a random digit table.
Settings and conduct
Patients with clinically diagnosed AGA, from the attendants of the Dermatology Outpatient Clinic of Alzahra Hospital, are randomly divided into 3 groups. All patients receive topical minoxidil but microneedling procedure (a total of six sessions with 2 weeks intervals) is applied only for 2 of three groups with different depth of needle in each group. Patients and investigators who collect post treatment data are not informed about group allocations.
Participants/Inclusion and exclusion criteria
Men and women between 18 years and 45 years of age with moderate to severe AGA are enrolled in this study. Patients with major systemic diseases; other forms of alopecia; skin disorders with risk of Koebner phenomenon; history of bleeding disorders; active infection at the scalp; keloidal tendency, pregnant and lactating women and patients with use of systemic medications for hair regrowth within last 6 months are not included in this study.
Intervention groups
Patients in control group are treated with topical 5% minoxidil lotion, applied twice daily for 12 weeks. patients in other two groups are instructed to apply minoxidil in a similar dose and will receive microneedling procedure at 2-weeks intervals for a period of 12 weeks. Depth of penetration is set at 1.2 mm for one group and 0.6 mm for the other one.
Main outcome variables
Pre-treatment and post treatment hair count and hair thickness; patients' satisfaction score and investigator's score based on photographs
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191203045592N1
Registration date:2020-01-03, 1398/10/13
Registration timing:retrospective
Last update:2020-01-03, 1398/10/13
Update count:0
Registration date
2020-01-03, 1398/10/13
Registrant information
Name
Samin Nabavinejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3131 7715
Email address
saminstrs@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
2018-08-23, 1397/06/01
Actual recruitment end date
2019-03-06, 1397/12/15
Trial completion date
2019-05-22, 1398/03/01
Scientific title
Comparative efficacy study of microneedling (2 different depth of penetration) and topical minoxidil versus topical minoxidil alone in androgenetic alopecia in patients referring to educational center of Isfahan university of medical sciences
Public title
Microneedling in androgenetic alopecia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with moderate to severe androgenetic alopecia
Patients who have not used systemic medications that influence hair growth within the past 6 months
Exclusion criteria:
Patients with other forms of alopecia, such as telogen effluvium and alopecia areata
Patients with history of bleeding disorders
Patients with keloidal tendency
Patients with active infection at the microneedling site
Patients with skin dermatosis with risk of Koebner phenomenon, such as psoriasis and lichen planus
Pregnant and lactating women
Patients with any major systemic disease
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Actual sample size reached:
59
Randomization (investigator's opinion)
Randomized
Randomization description
Each patient will be assigned a number from 01 to 60. Then we randomly choose a spot on the random digit table. we use the first 2 digits of the numbers on the chart (since we have a population of 60 patients) and document the first 20 numbers that are less than 61. Patients with these numbers are allocated to control group. Patients with the next 20 numbers collected from the chart, are allocated to microneedling group with a depth of 1.2 mm. the rest of the patients belong to the third group( microneedling with a depth of 0.6 mm). Patients are not aware of group allocation.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients in control group are treated with topical minoxidil solution alone. Patients in other two groups receive microneedling procedure other than topical minoxidil but depth of needle penetration is different between these two groups and patients are not aware of needle depth of penetration used for them.
A second investigator compares pre treatment and post treatment photographs of patients and evaluates data collected from hair analysis system while he does not know which experimental group patient belongs to.
Placebo
Not used
Assignment
Parallel
Other design features
Three experimental groups are evaluated in this study. All patients receive a topical drug with a similar dose. patients in two intervention groups receive microneedling procedure with different settings ,other than topical solution.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Control group: Use 1 CC of topical 5% minoxidil lotion (Pakdarou co., Tehran, Iran) applied twice daily for 12 weeks
Category
Treatment - Drugs
2
Description
Intervention group no.1: Use 1 CC of topical 5% minoxidil lotion (Pakdarou co., Tehran, Iran) applied twice daily for 12 weeks as well as 6 sessions of microneedling procedure with a microneedle depth of 1.2 mm, at 2-weeks intervals
Category
Treatment - Devices
3
Description
Intervention group no.2: Use 1 CC of topical 5% minoxidil lotion (Pakdarou co., Tehran, Iran) applied twice daily for 12 weeks as well as 6 sessions of microneedling procedure with a microneedle depth of 0.6 mm, at 2-weeks intervals