Investigation of the efficacy of topical latanoprost 0.005% combined with microneedling in comparisson to microneedling in the treatment of the patients with scalp patchy alopecia areata
Determination of the efficacy of topical latanoprost 0.005% combined with microneedling in comparison to microneedling in the treatment of the patients with scalp patchy alopecia areata
Design
Phase 3, parallel group, clinical trial, with consecutive sampling, including 20 patients, double blinded, computerized randomized with permuted blocks
Settings and conduct
The study is conducted in the Imam Reza and Shahid Faghihi clinics of Shiraz University of Medical Sciences randomly with latanoprost combined with microneedling on patches of alopecia areata of one side of scalp(3 session every two week) and microneedling on patches of alopecia areata of the other side of scalp (3 session every two week). The patients are assessed at the beginning of treatment, every two week visits for procedure and 3 month after the first visit by photography and dermoscopy. The investigator and/or outcome assessor(both of them is attending) and patient are blind to the type of treatment.
Participants/Inclusion and exclusion criteria
The inclusion criteria include:
1.age> 18 years old
2.AA coverage <25% of scalp surface
3.presence of 2-5 patches
The exclusion criteria include:
1.allergy or hypersensitivity to any component of treatment products
2.pregnancy or lactation
3.progressive disease
Intervention groups
Intervention side:topical latanoprost combined with microneedling of patches of alopecia areata on one side of scalp three sessions every two week
Control side: Microneedling of the patches of alopecia areata on opposite side of scalp three sessions every two week
Main outcome variables
terminal hair growth grade change;rate of patch size change;patient satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220316054304N1
Registration date:2022-09-05, 1401/06/14
Registration timing:registered_while_recruiting
Last update:2022-09-05, 1401/06/14
Update count:0
Registration date
2022-09-05, 1401/06/14
Registrant information
Name
Mehrnoosh Taheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3648 4599
Email address
xghazal1369x@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-03, 1401/06/12
Expected recruitment end date
2023-09-03, 1402/06/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the efficacy of topical latanoprost 0.005% combined with microneedling in comparisson to microneedling in the treatment of the patients with scalp patchy alopecia areata
Public title
Effect of topical Latanoprost combined with microneedling in the treatment of alopecia areata
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age> 18 years old
AA coverage <25% of scalp surface
presence of 2-5 patches
discontinue of intralesional triamcinolone treatment at least 2 weeks earlier
stable disease without the appearance of a new patch or increase in the size of the patches for at least 15 days
Exclusion criteria:
allergy or hypersensitivity to any component of treatment products
pregnancy or lactation
any skin infection on treatment area
severe medical illness
simultaneous use of immunosuppressant or anticoagulant medication
progressive disease
posetive hair pull test
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
20
More than 1 sample in each individual
Number of samples in each individual:
2
right side or left side patches will be recieved combined latanoprost with microneedling then opposite side will be recieved microneedling alone.
Randomization (investigator's opinion)
Randomized
Randomization description
The left or right sided patches are randomly allocated by block randomization method (block sizes: 4) to receive latanoprost combined microneedling .This randomization list is prepared by Random Allocation Software.
Patients will be randomly assigned into 2 groups(A or B)of 10 patients by using this computer software,which is done before the first session by a neutral colleague.
Group A will receive latanoprost combined microneedling on the patches of right side of scalp and just microneedling on the patches of left side of scalp.
Group B will receive latanoprost combined microneedling on the patches of left side of scalp and just microneedling on the patches of right side of scalp.
(Actually each participant is case and control simultaneously.)
Blinding (investigator's opinion)
Double blinded
Blinding description
this study is double-blinded.The investigator or outcome assessor (both of them is attending)is not present during doing procedures which is done by care provider.The patient is also unaware of applying latanoprost due to anesthesia induced by xyla-p.
(Actually each participant is case and control simultaneously.)
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand St., Shiraz. Iran
City
Shiraz
Province
Fars
Postal code
7134845794
Approval date
2022-05-09, 1401/02/19
Ethics committee reference number
IR.SUMS.MED.REC.1401.072
Health conditions studied
1
Description of health condition studied
alopecia areata
ICD-10 code
L63.8
ICD-10 code description
other alopecia areata
Primary outcomes
1
Description
terminal hair growth change
Timepoint
The patients will be assessed in 2 every 2 weeks visits for procedures, and 3 months after the first visit.
Method of measurement
Terminal hair growth change garde into following 6 grade:Grade 0:no change or further hair loss /Grade 1: regrowth of 1-24% terminal hair /Grade 2: regrowth of 25-49% terminal hair /Grade 3: regrowth of 50-74% terminal hair /Grade 4: regrowth of 75-99% terminal hair /Grade 5:regrowth of 100% terminal hair
Secondary outcomes
1
Description
rate of patch size change
Timepoint
The patients will be assessed in 2 every 2 weeks visits for procedures, and 3 months after the first visit.
Method of measurement
Rate of size change (%)= Baseline size-Follow up size/Baseline size ×۱۰۰
2
Description
patient satisfaction
Timepoint
The patients will be assessed in 2 every 2 weeks visits for procedures, and 3 months after the first visit.
Method of measurement
A 5-point scale. 4: Extremely satisfied, 3:Very satisfied, 2: satisfied, 1: Slightly satisfied, 0: Not satisfied
Intervention groups
1
Description
Intervention side: Under aseptic precaution microneedling is performed by Dr.pen ULTIMA-A6 manufactured in USA. The device is an automated microneedling device, with 12pins cartridge. The depth of penetration will be 2 millimeters at highest speed. The device will be moving on the on right or left side of scalp patches till uniform pinpoint bleedings will be occurred on these patches.Topical eye drop latanoprost 0.005% (lataprost: Sina daroo, Tehran, Iran)will be applied on these patches by a strile swap twice ,immediately before and after performing microneedling. All of these procedures (microneedling combined with latanoprost)will be done every 2 weeks for 3 sessions.
Category
Treatment - Surgery
2
Description
Control side:Under aseptic precaution microneedling is performed by Dr.pen ULTIMA-A6 manufactured in USA. The device is an automated microneedling device, with 12pins cartridge. The depth of penetration will be 2 millimeters at highest speed. The device will be moving on opposite side of scalp patches that side have been received latanoprost combined microneedling till uniform pinpoint bleedings will be occurred on these patches.This procedure( microneedling standalone) will be done every 2 weeks for 3 sessions.