Lentigo SolarCRYO-EC4NCT05014321
Cyto-selective Difluoroethane-based Cryotherapy in the Treatment of Brown Spots PROOF OF CONCEPT
A study testing EC16 medical device (CE marked), device prototype (810A-v1) and device prototype (810B-v1) in people with Lentigo Solar, run by Cryonove Pharma at 1 site in Ukraine.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Lentigo Solar
- What is being tested?
- EC16 medical device (CE marked), device prototype (810A-v1) and device prototype (810B-v1)
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 1 siteUkraine
- Study dates
- 14 May 2021to 16 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Tolerance and the Mode of Administration of Cyto-selective Difluoroethane-based Cryotherapy in the Treatment of Brown Spots
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.
Read the 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.
- Conditions
- Lentigo Solar
- Being tested
- EC16 medical device (CE marked), device prototype (810A-v1), device prototype (810B-v1), device prototype (810C-v1)
- Keywords
- Cryotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EC16 medical device (CE marked)Device
Also called CNV Body
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).
device prototype (810C-v1)Device
Application on brown spots located on the face (4 treatments during the study).
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Day 56
Secondary outcomes (7)
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.
Measured: Day 0/Time 0 to Day 56
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.
Measured: Day 0/Time 0 to Day 56
TOLERABILITY : Erythema
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.
Measured: Day 0/Time 0 to Day 56
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.
Measured: Day 0/Time 0 to Day 56
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.
Measured: Day 56
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.
Measured: From Day 2 to Day 42
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.
Measured: Day 0/Time 0 to Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start14 May 2021
- Primary completion20 May 2021
- Study completion16 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lentigo SolarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cryonove Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dermatech, INNOVSOLUTION, CEISO
- Responsible party
- Sponsor
- Investigators
- Natalia Didenko, MD, Principal investigator, VIDNOVLENNYA invetigation site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05014321
- Sponsor's protocol ID
- CRYO-N° 21D588A0001
- Acronym
- CRYO-EC4
- Status last verified
- Jun 2022
- First submitted
- 12 Jul 2021
- Last updated
- 30 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Tolerance and the Mode of Administration of Cyto-selective Difluoroethane-based Cryotherapy in the Treatment of Brown Spots
- ClinicalTrials.gov ID
- NCT05014321
- Acronym / sponsor ID
- CRYO-EC4 / CRYO-N° 21D588A0001
- Conditions
- Lentigo Solar
- Keywords
- Cryotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Cryonove PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Dermatech, INNOVSOLUTION, CEISO
- Study start
- 14 May 2021 (actual)
- Primary completion
- 20 May 2021 (actual)
- Study completion
- 16 Jul 2021 (actual)
- First posted
- 20 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EC16 medical device (CE marked)Also: CNV BodyApplication on brown spots located on the face (1 treatment during the study). | 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). | Device | – |
Primary outcome
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.
7 secondary outcomes
TOLERABILITY : Hyperpigmentation
Time frame: Day 0/Time 0 to Day 56
TOLERABILITY : Hypopigmentation
Time frame: Day 0/Time 0 to Day 56
TOLERABILITY : Erythema
Time frame: Day 0/Time 0 to Day 56
TOLERABILITY : Skin sensation
Time frame: Day 0/Time 0 to Day 56
PERFORMANCE: Standardized photographs by C-Cube® acquisition
Time frame: Day 56
EFFICACY: Self-assessment of the subject
Time frame: From Day 2 to Day 42
TOLERABILITY: other expected events
Time frame: Day 0/Time 0 to Day 56
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
- Individual participant dataSharing planned: No
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CLINICAL INVESTIGATION TO EVALUATE THE EFFICACY AND SAFETY OF EPILADY PROTOTYPE DEVICE FOLLOWED BY APPLICATION OF A TOPICAL FORMULA ON DEPIGMENTATION OF LENTIGO SPOTS
Solar Lentigo
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natalia Didenko, MD principal investigator
VIDNOVLENNYA invetigation site
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EC16 medical device (CE marked), device prototype (810A-v1) and device prototype (810B-v1) in people with Lentigo Solar, run by Cryonove Pharma at 1 site in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TOLERABILITY : Post-treatment pain assessement (time frame: Day 0 (Time1 defined as 15 minutes post-treatment)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2022.