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Cyto-selective Difluoroethane-based Cryotherapy in the Treatment of Brown Spots PROOF OF CONCEPT (CRYO-EC4)

Primary Purpose

Lentigo Solar

Status

Completed

Phase

Not Applicable

Locations

Ukraine

Study Type

Interventional

Intervention

EC16 medical device (CE marked)

device prototype (810A-v1)

device prototype (810B-v1)

device prototype (810C-v1)

About this trial

This is an interventional treatment trial for Lentigo Solar focused on measuring Cryotherapy

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Vidnovlennya

Outcomes

Primary Outcome Measures

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.

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.

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.

Secondary Outcome Measures

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.

TOLERABILITY : Hypopigmentation

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 5 points (0 to 4) will be used: 0=no hypopigmented lesion, 1= very slight area of hypopigmentation of very small size and very slightly fairer than the surrounding skin, 2= slight area of hypopigmentation of small size and slightly fairer than the surrounding skin, 3= moderate : area of hypopigmentation of moderate size and much fairer than the surrounding skin, 4= severe : area of hypopigmentation of large size and much fairer than the surrounding skin. The expected outcomes are Score ≤ 3 (area of hypopigmentation of moderate size and much fairer than the surrounding skin) for the CNV body device and Score ≤ 2 (slight area of hypopigmentation of small size and slightly fairer than the surrounding skin) for each prototype.

TOLERABILITY : Erythema

TOLERABILITY : Skin sensation

The dermatologist will collect functional signs by asking the subjects about tightness, stinging, itching, warm or burning sensation. The evaluation will be performed visualy regarding 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 ≤ 3 (moderate) for the CNV body device and score ≤ 2 (mild) for each prototype device.

PERFORMANCE: Standardized photographs by C-Cube® acquisition

Standardized photographs will be taken using a Dermatoscope C-Cube® (PIXIENCE). The capture will be taken on the previously selected lentigo (and spotless surrounding each spot in the same acquisition) and a spotless area (one on face (same as clinical evaluation) and far from a lentigo spot). Acquisition will be performed at Day0/time 0 (before treatment) and at each visit. The expected outcomes at day 56 are a score delta (D56-D0) > 2,5 for ITA of lentigo spot for the CNV Body device and a score delta (D56-D0) > 2 for ITA of lentigo spot for the prototype devices.

EFFICACY: Self-assessment of the subject

Data will be completed by a questionnaire elaborated by the sponsor and filled in by subjects. It allowed obtaining the subjective appraisal of subject on tested laser act using the following 5-point scale: agree; quite agree; neither agree, nor disagree; quite disagree; disagree. The items are the following: The spot seems clearer. The size of the spot seems reduced. The spot seems less visible. The expected results are subject appraisal at day 42 "agree" on the 3 parameters a for the CNV Body device and "agree" or "quite agree" on the 3 parameters for the prototype devices.

TOLERABILITY: other expected events

Clinical evaluation of treated lentigo spot will be performed by a Dermatologist regarding dryness, desquamation, fissures, cracks, roughness or crust. The evaluation will be done visualy by scoring on the selected lentigo spots and surrounded spotless skin area around the spot skin, with standardized position and lighting. 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 ≤ 3 (moderate) for the CNV body device and score ≤ 2 (mild) for each prototype device.

Full Information

NCT ID

NCT05014321

First Posted

July 12, 2021

Last Updated

June 28, 2022

Sponsor

Cryonove Pharma

Collaborators

Dermatech, INNOVSOLUTION, CEISO

1. Study Identification

Unique Protocol Identification Number

NCT05014321

Brief Title

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

Acronym

CRYO-EC4

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

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Completed

Study Start Date

May 14, 2021 (Actual)

Primary Completion Date

May 20, 2021 (Actual)

Study Completion Date

July 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cryonove Pharma

Collaborators

Dermatech, INNOVSOLUTION, CEISO

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lentigo Solar

Keywords

Cryotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

Masking

ParticipantCare ProviderInvestigator

Masking Description

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.

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

EC16 medical device (CE marked)

Other Intervention Name(s)

CNV Body

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

device prototype (810A-v1)

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

device prototype (810B-v1)

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

device prototype (810C-v1)

Intervention Description

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

Primary Outcome Measure Information:

Title

TOLERABILITY : Post-treatment pain assessement

Description

Time Frame

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

Title

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

Description

Time Frame

Day 56

Title

PERFORMANCE : Skin color evaluation

Description

Time Frame

Day 56

Secondary Outcome Measure Information:

Title

TOLERABILITY : Hyperpigmentation

Description

Time Frame

Day 0/Time 0 to Day 56

Title

TOLERABILITY : Hypopigmentation

Description

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 5 points (0 to 4) will be used: 0=no hypopigmented lesion, 1= very slight area of hypopigmentation of very small size and very slightly fairer than the surrounding skin, 2= slight area of hypopigmentation of small size and slightly fairer than the surrounding skin, 3= moderate : area of hypopigmentation of moderate size and much fairer than the surrounding skin, 4= severe : area of hypopigmentation of large size and much fairer than the surrounding skin. The expected outcomes are Score ≤ 3 (area of hypopigmentation of moderate size and much fairer than the surrounding skin) for the CNV body device and Score ≤ 2 (slight area of hypopigmentation of small size and slightly fairer than the surrounding skin) for each prototype.

Time Frame

Day 0/Time 0 to Day 56

Title

TOLERABILITY : Erythema

Description

Time Frame

Day 0/Time 0 to Day 56

Title

TOLERABILITY : Skin sensation

Description

Time Frame

Day 0/Time 0 to Day 56

Title

PERFORMANCE: Standardized photographs by C-Cube® acquisition

Description

Time Frame

Day 56

Title

EFFICACY: Self-assessment of the subject

Description

Time Frame

From Day 2 to Day 42

Title

TOLERABILITY: other expected events

Description

Time Frame

Day 0/Time 0 to Day 56

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Natalia Didenko, MD

Organizational Affiliation

VIDNOVLENNYA invetigation site

Official's Role

Principal Investigator

Facility Information:

Facility Name

Vidnovlennya

City

Zhytomyr

ZIP/Postal Code

10014

Country

Ukraine

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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