Clinical trial NCT03225729: Assessment of CRYOBEAUTY MAINS ET DECOLLETE Versus Liquid Nitrogen Cryotherapy, in the Treatment of Solar Lentigines
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Solar Lentigo
Lead sponsor: Cryobeauty
Sponsor class: INDUSTRY
Collaborators: name: CEISO
First posted: 2017-07-21
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Phototype II to IV
* Presenting solar lentigos on both hands and neck, diameter ≤ 6mm
* Accepting not to expose the body to sunlight or artificial UV rays during the study
* Affiliate to a health insurance plan
* Having undergone a general clinical examination attesting to his / her ability to participate in the study
* Having given written consent

Exclusion Criteria:

* Having carried out aesthetic care (exfoliants, scrubs or self-tanning, manicure, hand care, UV ...) in the month before the start of the study, at the level of the hands and/or neckline.
* Having applied a depigmenting product in the month preceding the start of the study, at the level of the hands and/or neckline.
* Having carried out aesthetic care at a dermatologist (laser, IPL, peeling, depigmenting creams, cryotherapy ...), at the level of the hands and/or neckline, during the last six months
* Dermatosis, autoimmune disease (vitiligo), systemic, chronic or acute disease, or any other disease that may interfere with the treatment or influence the results of the study (people with diabetes, circulatory problems, cold allergies, With Raynaud's syndrome ...)
* Receiving general or local treatment (corticosteroids ...) likely to interfere with the evaluation of the studied parameters.
* Participating in another study or being in an exclusion period from a previous study
* Being incapable of following the requirements of the protocol
* Person protected by law
* Unable to read and write French
* Pregnant woman or woman wishing to be pregnant during the study, or during breastfeeding period
* Women of childbearing age who do not have contraception

Primary outcomes:
measure: Performance assessment of new cryotherapy device "CRYOTHERAPY MAIN ET DECOLLETE" to treat solar lentigo spots on the hands.
timeFrame: 8 weeks
Secondary outcomes:
measure: Performance assessment of CRYOBEAUTY HANDS AND DECOLLETE on the spots of the neckline.
timeFrame: 8 weeks
measure: Evolution of spot's colour
timeFrame: 0 weeks
measure: Evolution of spot's colour
timeFrame: 4 weeks
measure: Evolution of spot's colour
timeFrame: 8 weeks
measure: Pain assessment
timeFrame: 0 weeks
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 4 weeks
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 8 weeks
measure: Assessment of ergonomic and device's readiness
timeFrame: 0 weeks
measure: Assessment of volunteers feeling (QoL)
timeFrame: 0 weeks
Other outcomes:
Locations:
city: Nice
country: France
facility: CPCAD
Study officials:
affiliation: Centre de Pharmacologie Clinique Applique a la Dermatologie
name: Catherine Queille-Roussel, MD
role: PRINCIPAL_INVESTIGATOR
References: