Superficial Cryotherapy Versus Microneedling in Alopecia Areata

Not Applicable

Completed

• Conditions: Alopecia Areata
• Interventions: Procedure: DMEP kit; Device: Dermapen

• Registration Number: NCT04680234
• Lead Sponsor: Sohag University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2019-12-31
• Study Completion: 2020-06-01
• Status Verified: 2020-12
• Study First Submitted: 2020-12-15
• Study First Submitted QC: 2020-12-20
• Last Update Submitted: 2020-12-20
• Study First Posted: 2020-12-22
• Last Update Posted: 2020-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cryotherapy group	DMEP kit	Patients underwent superficial cryotherapy using dimethyl ether and propane (DMEP) at -57C very 2 weeks for maximum six sessions
Microneedling group	Dermapen	Patients underwent microneedling 2 weeks for maximum six sessions

Primary Outcome Measures

Name	Time	Method
Regrowth Scale	Change in regrowth scale from baseline to 3 months follow after end of sessions	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.

Secondary Outcome Measures

Name	Time	Method
SALT score	Change in salt score from baseline to 3 months follow after end of sessions	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.

Trial Locations

Locations (1)

Sohag Faculty of Medicine; 🇪🇬 Sohag, Egypt