Superficial Cryotherapy Versus Microneedling in Alopecia Areata

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

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.

Study Overview

• Status: Completed
• Conditions: Alopecia Areata
• Intervention / Treatment: Procedure: DMEP kit; Device: Dermapen

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Sohag, Egypt, 52324
    • Sohag faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change in regrowth scale from baseline to 3 months follow after end of sessions

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change in salt score from baseline to 3 months follow after end of sessions

Collaborators and Investigators

• Sponsor: Sohag University
• Investigators: Study Director: Zeinab A Gouda, MSc, Sohag faculty of medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2019
• Primary Completion (ACTUAL): December 31, 2019
• Study Completion (ACTUAL): June 1, 2020

Study Registration Dates

• First Submitted: December 15, 2020
• First Submitted That Met QC Criteria: December 20, 2020
• First Posted (ACTUAL): December 22, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 22, 2020
• Last Update Submitted That Met QC Criteria: December 20, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Cryotherapy; Microneedling; alopecia areata
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata
• Other Study ID Numbers: Alopecia2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: data will be provided upon request
• IPD Sharing Time Frame: Always
• IPD Sharing Access Criteria: Request to prinicipal investigator
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• 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