Superficial Cryotherapy Versus Microneedling in Alopecia Areata

Alopecia Areata Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04680234
• Other study ID #: Alopecia2020
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: June 1, 2020

Study information

• Verified date: December 2020
• Source: Sohag University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 1, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

Intervention

Procedure:
• DMEP kit
Superficial Cryotherapy using dimethyl ether and propane (DMEP) at -57C

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

Locations

Country	Name	City	State
Egypt	Sohag Faculty of Medicine	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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