CPCAD
Nice, France
NCT Number: NCT03225729
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.
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Notify Me30 year–75 year
All sexes
Interventional
Not applicable
Nice, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Other names: Azote médical liquide
Time frame: 8 weeks
Evaluation of CRYOBEAUTY MAINS's performance
Hexsel scoring:
Time frame: 8 weeks
Evaluation of CRYOBEAUTY MAINS's performance
Hexsel scoring:
Time frame: 0 weeks
Colours assessment: by using Mexameter® MX 18
Time frame: 4 weeks
Colours assessment: by using Mexameter® MX 18
Time frame: 8 weeks
Colours assessment: by using Mexameter® MX 18
Time frame: 0 weeks
VAS
Time frame: 4 weeks
Adverse events [Safety and Tolerability]
Time frame: 8 weeks
Adverse events [Safety and Tolerability]
Time frame: 0 weeks
Ergonomic and device's readiness questionnaire: 6 QCM questions are given to the participants
Time frame: 0 weeks
MelasQoL (Melasma. Quality of Life Scale)
Cryobeauty
Industry
Prospective Clinical Trial to Assess the Performance of a Cyto-selective Cryotherapye "CRYOBEAUTY MAINS ET DECOLLETE" Compared With Liquid Nitrogen Cryotherapy in the Treatment of Solar Lentigines in 30 Patients
Acronym: CBT-EC2
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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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