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