Clinical trial NCT05014321: Cyto-selective Difluoroethane-based Cryotherapy in the Treatment of Brown Spots PROOF OF CONCEPT
Official title: Evaluation of the Tolerance and the Mode of Administration of Cyto-selective Difluoroethane-based Cryotherapy in the Treatment of Brown Spots
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lentigo Solar
Keywords: Cryotherapy
Lead sponsor: Cryonove Pharma
Sponsor class: INDUSTRY
Collaborators: name: Dermatech
name: INNOVSOLUTION
name: CEISO
First posted: 2021-08-20
Enrollment: 12
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: CRYO (N° 21D588A0001) study aims to evaluate the tolerance and adjust the mode of administration of a cyto-selective difluoroethane-based cryotherapy in the treatment of brown spots.

The study is a proof of concept on a small panel of subjects and has been designed to be interventional, monocentric, randomized and double blind.

The study will include three device prototypes and a CE marked device (trademark URGO CRYOBEAUTY MAINS-BRAS-JAMBES) used as reference.

Detailed description: Solar lentigo is a harmless patch of darkened skin. It results from exposure to ultraviolet (UV) radiation, which causes local proliferation of melanocytes and accumulation of melanin within the skin cells (keratinocytes). Solar lentigos or lentigines are very common, especially in people over the age of 40 years.

CRYONOVE PHARMA develops and manufactures cryotherapy-based devices to improve skin appearance and treat lentigo spot. The mode of action of CRYONOVE devices consists to "provoke a selective cell death (melanocyte \& melanosome) by thermic shock induced by a rapid decrease in skin temperature via the diffusion of difluoroethane gas to the skin".

In this proof of concept study, the sponsor aims to assess the tolerance and the admininistration mode of cryogenic spray which could be used for lentigo treatment on the face.

The study is exploratory, interventional, monocentric, randomized and double blind.

Three prototypes of devices for face are compared to a CE marking device (trademark URGO CRYOBEAUTY MAINS-BRAS-JAMBES) used as reference.

Twelve subjects with at least 4 spots on face are expected to be included, in order to evaluate a minimum of 48 brown spots. Volunteers are treated at T0 only with the reference device and at T0, T2, T4, T6 weeks with the prototype devices. The patient follow-up include 10 visits from D0 to D56.

Eligibility criteria: Inclusion Criteria:

* Female or male.
* Ages 30 to 75.
* Phototype II et III according to Fitzpatrick scale
* Featuring brown spots (solar lentigos) on the face ≥ 3 mm to ≤ 6 mm in diameter (at least 4 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 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 Criteria:

* Having performed cosmetic treatments (exfoliants, scrubs or self-tanners, manicures, 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, IPL, 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 (tutorship, 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.

Primary outcomes:
measure: TOLERABILITY : Post-treatment pain assessement
timeFrame: Day 0 (Time1 defined as 15 minutes post-treatment)
measure: TOLERABILITY : Appearance of edemas, blisters, bubbles or scars.
timeFrame: Day 56
measure: PERFORMANCE : Skin color evaluation
timeFrame: Day 56
Secondary outcomes:
measure: TOLERABILITY : Hyperpigmentation
timeFrame: Day 0/Time 0 to Day 56
measure: TOLERABILITY : Hypopigmentation
timeFrame: Day 0/Time 0 to Day 56
measure: TOLERABILITY : Erythema
timeFrame: Day 0/Time 0 to Day 56
measure: TOLERABILITY : Skin sensation
timeFrame: Day 0/Time 0 to Day 56
measure: PERFORMANCE: Standardized photographs by C-Cube® acquisition
timeFrame: Day 56
measure: EFFICACY: Self-assessment of the subject
timeFrame: From Day 2 to Day 42
measure: TOLERABILITY: other expected events
timeFrame: Day 0/Time 0 to Day 56
Other outcomes:
Locations:
city: Zhytomyr
country: Ukraine
facility: Vidnovlennya
Study officials:
affiliation: VIDNOVLENNYA invetigation site
name: Natalia Didenko, MD
role: PRINCIPAL_INVESTIGATOR
References: