Superficial Cryotherapy Versus Microneedling in Alopecia Areata

Sponsor

Sohag University (Other)

Overall Status

Completed

CT.gov ID

NCT04680234

Collaborator

(none)

100

Enrollment

Location

Arms

Actual Duration (Months)

5.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is randomized comparative analytical prospective study that included patients with mild and moderate alopecia areata. Patients was divided into two groups Patients in the first group underwent Superficial cryotherapy using dimethyl ether and propane (DMEP) at -57C (Cryotherapy group). Patients in the second group underwent Microneedling (Microneedling group). A total of six sessions were done at 2 weeks interval. Patients were followed-up for next 3 months to evaluate the persistence of hair regrowth after therapy. Patients were assessed at baseline and during follow up using photography, Dermoscopy, SALT score and regrowth scale.

Condition or Disease	Intervention/Treatment	Phase
Alopecia Areata	Procedure: DMEP kit Device: Dermapen	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Patients will be divided into two groups (randomly assigned and comparably cross matched for age and sex) Cryotherapy group (No.= 50): Superficial cryotherapy using dimethyl ether and propane (DMEP) at -57C Microneedling group (No. = 50): MicroneedlingPatients will be divided into two groups (randomly assigned and comparably cross matched for age and sex) Cryotherapy group (No.= 50): Superficial cryotherapy using dimethyl ether and propane (DMEP) at -57C Microneedling group (No. = 50): Microneedling

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Comparative Study Between the Effect of Superficial Cryotherapy Using Dimethyl Ether and Propane Mixture and Microneedling in Treatment of Alopecia Areata

Actual Study Start Date :

Jan 1, 2019

Actual Primary Completion Date :

Dec 31, 2019

Actual Study Completion Date :

Jun 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Cryotherapy group Patients underwent superficial cryotherapy using dimethyl ether and propane (DMEP) at -57C very 2 weeks for maximum six sessions	Procedure: DMEP kit Superficial Cryotherapy using dimethyl ether and propane (DMEP) at -57C
Active Comparator: Microneedling group Patients underwent microneedling 2 weeks for maximum six sessions	Device: Dermapen Under aseptic precautions, the dermapen was moved on the alopecic patches diagonally, vertically and horizontally 4 to 5 times in each direction Pin point bleeding was taken as an end point

Arm

Intervention/Treatment

Active Comparator: Cryotherapy group

Patients underwent superficial cryotherapy using dimethyl ether and propane (DMEP) at -57C very 2 weeks for maximum six sessions

Procedure: DMEP kit

Superficial Cryotherapy using dimethyl ether and propane (DMEP) at -57C

Active Comparator: Microneedling group

Patients underwent microneedling 2 weeks for maximum six sessions

Device: Dermapen

Under aseptic precautions, the dermapen was moved on the alopecic patches diagonally, vertically and horizontally 4 to 5 times in each direction Pin point bleeding was taken as an end point

Outcome Measures

Primary Outcome Measures

Regrowth Scale [Change in regrowth scale from baseline to 3 months follow after end of sessions]
0 score (regrowth < 10%) no response score (regrowth 11-25%) poor response score (regrowth 26-50%) fair response score (regrowth 51-75%) satisfactory response score (regrowth ≥ 75%) excellent response.

Secondary Outcome Measures

SALT score [Change in salt score from baseline to 3 months follow after end of sessions]
SALT score is the sum of the percentage of hair loss in all the abovementioned areas. For example, if the percentage hair loss in vertex, right profile, left profile, and posterior aspect is 20, 30, 40, and 50% respectively; then, SALT score = (20 × 0.4) = (30 × 0.18) + (40 × 0.18) + (50 × 0.24) = 8 + 5.4 + 7.2 + 12 = 32.6.

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

ِAlopecia areata patients

Exclusion Criteria:

Alopecia totalis and universalis
ِAge less than four years.
ِPregnancy or breast-feeding.
ِActive infection at the site alopecia patch(s).
ِInflammation ate site of the alopecia patches
ِIntolerance to cold.
ِAssociated systemic illness such as thyroid, pernicious anaemia, diabetes mellitus, autoimmune connective tissue diseases.
ِPrevious treatment for alopecia areata over the last three months.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sohag Faculty of Medicine	Sohag		Egypt	52324

Sponsors and Collaborators

Sohag University

Investigators

Study Director: Zeinab A Gouda, MSc, Sohag Faculty of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zeinab Abu elbaha Gouda, Assistant lecturer of Dermatology, Venereology and Andrology, Sohag University

ClinicalTrials.gov Identifier:

NCT04680234

Other Study ID Numbers:

Alopecia2020

First Posted:

Dec 22, 2020

Last Update Posted:

Dec 22, 2020

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Zeinab Abu elbaha Gouda, Assistant lecturer of Dermatology, Venereology and Andrology, Sohag University

alopecia areata

Microneedling

Cryotherapy

Additional relevant MeSH terms:

Alopecia

Alopecia Areata

Study Results

No Results Posted as of Dec 22, 2020