NCT04680234

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 22, 2020

Completed
Last Updated

December 22, 2020

Status Verified

December 1, 2020

Enrollment Period

12 months

First QC Date

December 15, 2020

Last Update Submit

December 20, 2020

Conditions

Alopecia Areata

Keywords

alopecia areataMicroneedlingCryotherapy

Outcome Measures

Primary Outcomes (1)

  • Regrowth Scale

    0 score (regrowth \< 10%) no response 1. score (regrowth 11-25%) poor response 2. score (regrowth 26-50%) fair response 3. score (regrowth 51-75%) satisfactory response 4. score (regrowth ≥ 75%) excellent response.

    Change in regrowth scale from baseline to 3 months follow after end of sessions

Secondary Outcomes (1)

  • SALT score

    Change in salt score from baseline to 3 months follow after end of sessions

Study Arms (2)

Cryotherapy group

ACTIVE COMPARATOR

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

Procedure: DMEP kit

Microneedling group

ACTIVE COMPARATOR

Patients underwent microneedling 2 weeks for maximum six sessions

Device: Dermapen

Interventions

DMEP kitPROCEDURE

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

Cryotherapy group
DermapenDEVICE

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

Microneedling group

Eligibility Criteria

Age4 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • ِAlopecia areata patients

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag Faculty of Medicine

Sohag, 52324, Egypt

Location

MeSH Terms

Conditions

Alopecia Areata

Condition Hierarchy (Ancestors)

AlopeciaHypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Zeinab A Gouda, MSc

    Sohag Faculty of Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer of Dermatology, Venereology and Andrology

Study Record Dates

First Submitted

December 15, 2020

First Posted

December 22, 2020

Study Start

January 1, 2019

Primary Completion

December 31, 2019

Study Completion

June 1, 2020

Last Updated

December 22, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will share

data will be provided upon request

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Always
Access Criteria
Request to prinicipal investigator

Locations

EG(1)