Cyto-selective Difluoroethane-based Cryotherapy in the Treatment of Brown Spots PROOF OF CONCEPT

NCT05014321 | Completed

• 1 other identifier: CRYO-N° 21D588A0001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Lentigo Solar

Keywords

Cryotherapy

Outcome Measures

Primary Outcomes (3)

• TOLERABILITY : Post-treatment pain assessement

  The pain of the treatment will be assessed by the VAS (Visual Analogue Scale). Pain intensity is measured in millimeters by the distance from the position of the mark to the "no pain" extremity. Based on the distribution of pain VAS scores in postoperative patients, the following bounds were recommended for the assessment of this scale: no pain (0-4mm), mild pain (5-44mm), moderate pain (45-74 mm) and severe pain (75- 100 mm). The expected outcomes are pain score \< 44 mm (mild pain) for CNV Body and score \< 4 mm (no pain) for each prototype.

  Day 0 (Time1 defined as 15 minutes post-treatment)

• TOLERABILITY : Appearance of edemas, blisters, bubbles or scars.

  Clinical evaluation of treated lentigo spot will be performed by a Dermatologist by scoring with standardized position and lighting. The evaluation will be performed visualy on the selected lentigo spots and surrounded spotless skin area around the spot skin. A scale in 5 points (0 to 4) will be used : 0=none; 1=very mild; 2=mild; 3=moderate; 4=severe. The expected score is \< 1.

  Day 56

• PERFORMANCE : Skin color evaluation

  Clinical evaluation of each treated lentigo spot and spotless area (one on face and far from a lentigo spot) will be performed in blinded conditions by a trained assessor by scoring using L'OREAL ColorChart\* in standardized position and lighting. The score delta between Day 56 post treatment and D0 pre-treatment will be calculated. The expected results is a score delta (D56-D0) \< -1 for lighteness of lentigo spot. \*Jean de Rigal, Marie-Laurence Abella, Franck Giron, Laurence Caisey, Marc André Lefebvre - Development and validation of a new Skin Color Chart® - Skin Research1 Technology, January 2007.

  Day 56

Secondary Outcomes (7)

• TOLERABILITY : Hyperpigmentation

  Day 0/Time 0 to Day 56

• TOLERABILITY : Hypopigmentation

  Day 0/Time 0 to Day 56

• TOLERABILITY : Erythema

  Day 0/Time 0 to Day 56

• TOLERABILITY : Skin sensation

  Day 0/Time 0 to Day 56

• PERFORMANCE: Standardized photographs by C-Cube® acquisition

  Day 56

Interventions

EC16 medical device (CE marked) DEVICE

Application on brown spots located on the face (1 treatment during the study).

Also known as: CNV Body

device prototype (810A-v1) DEVICE

Application on brown spots located on the face (4 treatments during the study).

device prototype (810B-v1) DEVICE

Application on brown spots located on the face (4 treatments during the study).

device prototype (810C-v1) DEVICE

Application on brown spots located on the face (4 treatments during the study).

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cryonove Pharma: lead
• Dermatech: collaborator
• INNOVSOLUTION: collaborator
• CEISO: collaborator

Study Sites (1)

Vidnovlennya

Zhytomyr, 10014, Ukraine

Location

Study Officials

• Natalia Didenko, MD

  VIDNOVLENNYA invetigation site

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Each spot will be treated by a defined prototype / device (always the same prototype / device on the same spot all along the study - one unique prototype/device per spot). The application order of the different device prototypes (810A-v1), (810B-v1), (810C-v1) will be defined by randomization except for CNV Body that will always be applied last. Each prototype will be identified by a 3 characters internal code (00-x) corresponding to the treated spot with "00" corresponding to the subject number from 01 to 12 and "x" corresponding to the selected spot from A to D.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: August 20, 2021
• Study Start: May 14, 2021
• Primary Completion: May 20, 2021
• Study Completion: July 16, 2021
• Last Updated: June 30, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

UA (1)