Status:
COMPLETED
Tolerance of Cyto-selective Difluoroethane-based Cryotherapy
Lead Sponsor:
Cryonove Pharma
Collaborating Sponsors:
INNOVSOLUTION
CEISO
Conditions:
Solar Lentigo
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Cryotherapy is more and more used to improve skin appearance. Devices using difluoroethane, manufactured by CRYONOVE PHARMA, are already available on the local and international markets, e.g. CRYOBEAU...
Detailed Description
Prototypes (812A-v1), (812C-v1), (812D-v1) and (812F-v1) will be applied on hands areas by the same order for all volunteers using a reposition mask. On each hand 2 devices will be attributed starting...
Eligibility Criteria
Inclusion
- Female or male.
- Ages \> 18.
- Phototype V et VI (according with Fitzpatrick scale)
- Agreeing not to be exposed to the sun (or artificial UV) during the study.
- Informed, having undergone a general clinical examination attesting to his/her ability to participate in the study.
- Having given written consent for participation in the study.
- No suspicion of carcinoma after investigation by a dermatologist.
Exclusion
- Having performed cosmetic treatments (exfoliants, scrubs or self-tanners, facials, UV ...) in the month before the start of the study, at the level of the hand.
- Having applied a depraving product in the month prior to the start of the study, at the hands (except cleansing products).
- Having performed cosmetic treatments in a dermatologist (laser, IPL (Intensed pulsed light), peeling, creams, cryotherapy ...), on the hands in the last 6 months.
- With dermatosis, autoimmune disease, systemic, chronic or acute disease, or any other pathology that may interfere with treatment or influence the results of the study (people with diabetes or circulatory problems,allergic to cold, Raynaud's syndrome...).
- Receiving treatment by general or local (dermo corticoids, corticosteroids, diuretics ...) likely to interfere with the evaluation of the parameter studied.
- Participating in another study or being excluded from a previous study.
- Unable to follow the requirements of the protocol.
- Vulnerable: whose ability or freedom to give or refuse consent is limited.
- Major protected by law (tutorship, curatorship, safeguarding justice...).
- People unable to understand, read and write English/French/Ukrainian language. However, the impartial witness will be introduced to current study to make translations if necessary, during all course of the study for each volunteer and respective section for signature and date will be implemented to the "Information Sheet and Informed Consent Form".
- Unable to be contacted urgently over the phone.
- For female subjects:
- Pregnant woman (or wishing to be pregnant during study) or while breastfeeding.
- A woman, who does not use effective methods of contraception.
Key Trial Info
Start Date :
January 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 7 2022
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT05322668
Start Date
January 17 2022
End Date
February 7 2022
Last Update
August 19 2022
Active Locations (1)
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1
VIDNOVLENNYA medical center
Zhytomyr, Ukraine, 10014