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Superficial Cryotherapy Versus Microneedling in Alopecia Areata

NCT ID: NCT04680234

Last Updated: 2020-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Alopecia Areata

Keywords

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alopecia areata Microneedling Cryotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cryotherapy group

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

Group Type ACTIVE_COMPARATOR

DMEP kit

Intervention Type PROCEDURE

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

Microneedling group

Patients underwent microneedling 2 weeks for maximum six sessions

Group Type ACTIVE_COMPARATOR

Dermapen

Intervention Type DEVICE

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

Interventions

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DMEP kit

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

Intervention Type PROCEDURE

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Zeinab Abu elbaha Gouda

Assistant lecturer of Dermatology, Venereology and Andrology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zeinab A Gouda, MSc

Role: STUDY_DIRECTOR

Sohag Faculty of Medicine

Locations

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Sohag Faculty of Medicine

Sohag, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Alopecia2020

Identifier Type: -

Identifier Source: org_study_id