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

Cryonove Pharma12 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Lentigo Solar

Interventions

EC16 medical device (CE marked)DEVICE

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

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).

Eligibility

Sex: ALLMin age: 30 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Vidnovlennya

Zhytomyr, Ukraine

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Day 56

Secondary Outcomes

TOLERABILITY : Hyperpigmentation

Clinical evaluation of hyperpigmentation on each selected and 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. A scale in 6 points (0 to 5) will be used : 0=Clear of hyperpigmentation, 1= Almost clear of hyperpigmentation, 2=mild, but noticeable hyperpigmentation, 3=moderate hyperpigmentation (medium brown in quality), 4=severe hyperpigmentation (dark brown in quality), 5= very severe hyperpigmentation (very dark brown, almost black in quality). The expected outcomes are Score ≤ 3 (moderate hyperpigmentation, medium brown in quality) for CNV Body and Score ≤ 2 (mild, but noticeable hyperpigmentation) for each prototype.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.