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Superficial Cryotherapy Versus Microneedling in Alopecia Areata

Primary Purpose

Alopecia Areata

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
DMEP kit
Dermapen
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alopecia Areata focused on measuring alopecia areata, Microneedling, Cryotherapy

Eligibility Criteria

4 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Sohag Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Cryotherapy group

Microneedling group

Arm Description

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

Patients underwent microneedling 2 weeks for maximum six sessions

Outcomes

Primary Outcome Measures

Regrowth Scale
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
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.

Full Information

First Posted
December 15, 2020
Last Updated
December 20, 2020
Sponsor
Sohag University
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1. Study Identification

Unique Protocol Identification Number
NCT04680234
Brief Title
Superficial Cryotherapy Versus Microneedling in Alopecia Areata
Official Title
Comparative Study Between the Effect of Superficial Cryotherapy Using Dimethyl Ether and Propane Mixture and Microneedling in Treatment of Alopecia Areata
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
June 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia Areata
Keywords
alopecia areata, Microneedling, Cryotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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): Microneedling
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cryotherapy group
Arm Type
Active Comparator
Arm Description
Patients underwent superficial cryotherapy using dimethyl ether and propane (DMEP) at -57C very 2 weeks for maximum six sessions
Arm Title
Microneedling group
Arm Type
Active Comparator
Arm Description
Patients underwent microneedling 2 weeks for maximum six sessions
Intervention Type
Procedure
Intervention Name(s)
DMEP kit
Intervention Description
Superficial Cryotherapy using dimethyl ether and propane (DMEP) at -57C
Intervention Type
Device
Intervention Name(s)
Dermapen
Intervention Description
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
Primary Outcome Measure Information:
Title
Regrowth Scale
Description
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.
Time Frame
Change in regrowth scale from baseline to 3 months follow after end of sessions
Secondary Outcome Measure Information:
Title
SALT score
Description
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.
Time Frame
Change in salt score from baseline to 3 months follow after end of sessions

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zeinab A Gouda, MSc
Organizational Affiliation
Sohag Faculty of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Sohag Faculty of Medicine
City
Sohag
ZIP/Postal Code
52324
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
data will be provided upon request
IPD Sharing Time Frame
Always
IPD Sharing Access Criteria
Request to prinicipal investigator

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Superficial Cryotherapy Versus Microneedling in Alopecia Areata

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