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Trial record 3 of 650 for:    cyto therapeutics

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05014321
Recruitment Status : Completed
First Posted : August 20, 2021
Last Update Posted : June 30, 2022
Sponsor:
Collaborators:
DERMATECH
INNOVSOLUTION
CEISO
Information provided by (Responsible Party):
Cryonove Pharma

Tracking Information
First Submitted Date  ICMJE July 12, 2021
First Posted Date  ICMJE August 20, 2021
Last Update Posted Date June 30, 2022
Actual Study Start Date  ICMJE May 14, 2021
Actual Primary Completion Date May 20, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 13, 2021)
  • TOLERABILITY : Post-treatment pain assessement [ Time Frame: Day 0 (Time1 defined as 15 minutes post-treatment) ]
    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. [ Time Frame: Day 56 ]
    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 [ Time Frame: Day 56 ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 13, 2021)
  • TOLERABILITY : Hyperpigmentation [ Time Frame: Day 0/Time 0 to Day 56 ]
    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 [ Time Frame: Day 0/Time 0 to Day 56 ]
    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 [ Time Frame: Day 0/Time 0 to Day 56 ]
    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 ≤ 3 (moderate) for the CNV body device and score ≤ 2 (mild) for each prototype device.
  • TOLERABILITY : Skin sensation [ Time Frame: Day 0/Time 0 to Day 56 ]
    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 [ Time Frame: Day 56 ]
    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 [ Time Frame: From Day 2 to Day 42 ]
    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 [ Time Frame: Day 0/Time 0 to Day 56 ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cyto-selective Difluoroethane-based Cryotherapy in the Treatment of Brown Spots PROOF OF CONCEPT
Official Title  ICMJE Evaluation of the Tolerance and the Mode of Administration of Cyto-selective Difluoroethane-based Cryotherapy in the Treatment of Brown Spots
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
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.

Primary Purpose: Treatment
Condition  ICMJE Lentigo Solar
Intervention  ICMJE
  • Device: EC16 medical device (CE marked)
    Application on brown spots located on the face (1 treatment during the study).
    Other Name: CNV Body
  • Device: device prototype (810A-v1)
    Application on brown spots located on the face (4 treatments during the study).
  • Device: device prototype (810B-v1)
    Application on brown spots located on the face (4 treatments during the study).
  • Device: device prototype (810C-v1)
    Application on brown spots located on the face (4 treatments during the study).
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 28, 2022)
12
Original Actual Enrollment  ICMJE
 (submitted: August 13, 2021)
14
Actual Study Completion Date  ICMJE July 16, 2021
Actual Primary Completion Date May 20, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Ukraine
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05014321
Other Study ID Numbers  ICMJE CRYO-N° 21D588A0001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Cryonove Pharma
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Cryonove Pharma
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • DERMATECH
  • INNOVSOLUTION
  • CEISO
Investigators  ICMJE
Principal Investigator: Natalia Didenko, MD VIDNOVLENNYA invetigation site
PRS Account Cryonove Pharma
Verification Date June 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP