Status:
COMPLETED
Tolerance and Mode of Administration of Cyto-selective Cryotherapy Treatments in Face Brown Spots: Proof of Concept
Lead Sponsor:
Cryonove Pharma
Collaborating Sponsors:
Dermatech
CEISO
Conditions:
Solar Lentigo
Eligibility:
FEMALE
30-75 years
Phase:
NA
Brief Summary
Solar lentigos or lentigines are harmless patch of darkened skin, of different sizes and colors, due to the exposure to UV radiation. They are very common, especially in people over the age of 40 year...
Detailed Description
Prototypes (810A-v1), (810B-v1) and (810C-v1) will be applied on brown spots located on the face. Regarding the randomization list, each spot will be treated by a defined prototype / device (same prot...
Eligibility Criteria
Inclusion
- Phototype II et III (according with Fitzpatrick scale)
- Featuring brown spots (solar lentigos) on the face ≥ 3mm to 6 mm in diameter (at least 2-3 spots per subject).
- 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 face.
- Having applied a depraving product in the month prior to the start of the study, at the level of the face.
- Having performed cosmetic treatments in a dermatologist (laser, intense pulsed light, peeling, creams, cryotherapy ...), at the level of the face 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 (under guardianship, under curatorship, safeguarding justice...).
- People unable to read and write Ukrainian language.
- 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 :
December 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2022
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT05203263
Start Date
December 15 2021
End Date
February 15 2022
Last Update
August 19 2022
Active Locations (1)
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1
VIDNOVLENNYA medical center
Zhytomyr, Ukraine, 10014