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Assessment of CRYOBEAUTY MAINS ET DECOLLETE Versus Liquid Nitrogen Cryotherapy, in the Treatment of Solar Lentigines

NCT03225729 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-01-04

No results posted yet for this study

Summary

This study evaluates the performance of new technology "CRYOTHERAPY MAINS ET DECOLLETE" against a classic cryotherapy "Nitrogen Liquid " to treat solar lentigines.

The hands and the neckline will be randomised, either left or right side and treated by two cryotherapy devices:

1. CRYOTHERAPY MAINS ET DECOLLETE is the device under evaluation.
2. Liquid nitrogen is a comparator device.

Conditions

  • Solar Lentigo

Interventions

DEVICE

CRYOBEAUTY MAINS ET DECOLLETE

The intervention lasts up to 6.5 s. The device will be applied on spots \<6 mm which are previously selected by the investigator team.

DEVICE

Liquid nitrogen

The intervention lasts up to 3 s. The liquid is stored in well-isolated recipients. Each patient has his recipient to avoid contamination. The investigator applies on spots \<6 mm a small amount of nitrogen liquid.

Sponsors & Collaborators

  • CEISO

    collaborator INDUSTRY

  • Cryobeauty

    lead INDUSTRY

Principal Investigators

  • Catherine Queille-Roussel, MD · Centre de Pharmacologie Clinique Applique a la Dermatologie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-25
Primary Completion
2017-12-22
Completion
2017-12-22

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03225729 on ClinicalTrials.gov