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Completed

NCT Number: NCT04680234

Superficial Cryotherapy Versus Microneedling in 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.

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Key information

Conditions

Alopecia Areata Alopecia Hair Diseases Hypotrichosis Skin Diseases Skin and Connective Tissue Diseases

Age range

4 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sohag Faculty of Medicine

Sohag, 52324, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DMEP kit

Procedure

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

Dermapen

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

Primary outcomes

  1. Regrowth Scale

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

    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.

Secondary outcomes

  1. SALT score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Dec 22, 2020
Registry last updated
Dec 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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