Solar LentigoAGILE3NCT05322668
Tolerance of Cyto-selective Difluoroethane-based Cryotherapy
A study testing Prototypes (812A-v1), (812C-v1), (812D-v1) and (812F-v1) in people with Solar Lentigo, run by Cryonove Pharma at 1 site in Ukraine.
Trial summary
Cryotherapy is more and more used to improve skin appearance. Devices using difluoroethane, manufactured by CRYONOVE PHARMA, are already available on the local and international markets, e.g. CRYOBEAUTY MAINS and CRYOBEAUTY CORPS. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Solar Lentigo
- What is being tested?
- Prototypes (812A-v1), (812C-v1), (812D-v1) and (812F-v1)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUkraine
- Study dates
- 17 Jan 2022to 7 Feb 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female or male.
- Ages > 18.
- Phototype V et VI (according with Fitzpatrick scale)
- Agreeing not to be exposed to the sun (or artificial UV) during the study.
- Informed, having undergone a general clinical examination attesting to his/her 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, facials, UV ...) in the month before the start of the study, at the level of the hand.
- Having applied a depraving product in the month prior to the start of the study, at the hands (except cleansing products).
- Having performed cosmetic treatments in a dermatologist (laser, IPL (Intensed pulsed light), peeling, creams, cryotherapy ...), on the hands 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 understand, read and write English/French/Ukrainian language. However, the impartial witness will be introduced to current study to make translations if necessary, during all course of the study for each volunteer and respective section for signature and date will be implemented to the "Information Sheet and Informed Consent Form".
- 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 of Cyto-selective Difluoroethane-based Cryotherapy
Cryotherapy is more and more used to improve skin appearance. Devices using difluoroethane, manufactured by CRYONOVE PHARMA, are already available on the local and international markets, e.g. CRYOBEAUTY MAINS and CRYOBEAUTY CORPS.
However, the cryogenic gas (conventional cryotherapy - liquid nitrogen) creates a dermabrasion of the skin surface and person receiving this kind of treatment presents an impaired skin during a few days following the treatment as temporary damage of stratum corneum, erythema, scars, burns.
Read more
Following the side effects occurring after conventional cryotherapy application, it seems interesting for the sponsor to select other sequences of a cryogenic spray (4 prototypes of devices) which could be used for lentigo treatment with a same benefit for the consumers without any safety outcomes.
This study will assess the use of different prototypes with a sequence of application of cryogenic gas which reaches a higher temperature than those which used with the reference device, in order to increase the acceptability of the device.
(CS4_3) proof of concept, interventional, monocentric, aims to evaluate the tolerance of cryotherapy treatments applied on healthy skin on the back of the hands.
The main objective of the study is to evaluate on phototype V and VI, the tolerance of 4 different conditions of cryotherapy treatments (4 prototypes) applied on healthy skin on the back of the hands.
Read the detailed description
Prototypes (812A-v1), (812C-v1), (812D-v1) and (812F-v1) will be applied on hands areas by the same order for all volunteers using a reposition mask. On each hand 2 devices will be attributed starting from the middle point of the hand toward to the lateral internal and lateral external edges of the hand. The distance between 2 treatment areas will be 2 cm.
Each area will be treated 1 time during the study at D0. The treatment will starts from right hand with prototypes (812A-v1) and (812C-v1), then left hands with the prototypes (812D-v1) and (812F-v1) .
Prior to any study device application, the dermatologist will assess the adverse events.
The dermatologist will verify that the skin has not been treated by cosmetic products (no presence of cream that could interfere with the treatment) and is dry.
The procedure will take place at the investigation site. An operator previously trained by the dermatologist will apply the study device to the patient's hand.
Subjects will lie down and the device will be administered upside down.
The prototypes will be applied 10 minutes apart so that pain can be measured without interference from application to application.
- Conditions
- Solar Lentigo
- Being tested
- Prototypes (812A-v1), (812C-v1), (812D-v1) and (812F-v1)
- Keywords
- Cryotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prototypes (812A-v1), (812C-v1), (812D-v1) and (812F-v1)Device
All the subjects will receive all the treatment in the same order.
On each hand 2 devices will be attributed as follow:
- Prototypes (812A-v1) will be applied on an area of the back of the patient's right hand, on healthy skin
- Prototypes (812C-v1) will be applied on an area of the back of the patient's right hand, on healthy skin
- Prototypes (812D-v1) will be applied on an area of the back of the patient's left hand, on healthy skin
- Prototypes (812F-v1) will be applied on an area of the back of the patient's left hand, on healthy skin
| Study group | Role | What they receive |
|---|---|---|
| Condition 1 | Experimental | All the subjects will receive all the treatment in the same order.
The following prototypes will be applied on hands areas:
Application of the prototype (812A-v1) at Day 0, Application of the prototype (812C-v1) at Day 0, Application of the prototype (812D-v1) at Day 0, Application of the prototype (812F-v1) at Day 0, Receives: Device: Prototypes (812A-v1), (812C-v1), (812D-v1) and (812F-v1) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline skin hyperpigmentation
This outcome is a tolerance assessment criteria. Clinical evaluation of hyperpigmentation on each selected and treated area will be performed by a Dermatologist using the Investigator's Global Assessment likert 6 points scale ranged from 0 to 5: 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)
Measured: Day 0, Day 2, Day 7, Day 21, Day 56
Change from baseline skin hypopigmentation
This outcome is a tolerance assessment criteria. Clinical evaluation of hypopigmentation on each selected and treated area will be performed by a Dermatologist using a likert 5 points scale ranged from 0 to 4: 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.
Measured: Day 0, Day 2, Day 7, Day 21, Day 56
Change from baseline skin appearance (Edemas, blisters, bubbles, scars, erythema)
his outcome is a tolerance assessment criteria. Clinical visual evaluation of selected area and surrounded spotless skin area around the spot skin will be performed. A likert scale in 5 points (0 to 4) will be used : 0=none; 1=very mild; 2=mild; 3=moderate; 4=severe.
Measured: Day 0, Day 2, Day 7, Day 21, Day 56
Change from baseline skin sensation (itching, tingling, burning sensations)
This outcome is a tolerance assessment criteria. Clinical visual evaluation of selected lentigo spots and around the spot skin will be performed. A likert scale in 5 points (0 to 4) will be used : 0=none; 1=very mild; 2=mild; 3=moderate; 4=severe.
Measured: Day 0, Day 2, Day 7, Day 21, Day 56
Post treatment pain
This outcome is a tolerance assessment criteria. 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.
Measured: Day 0
Other unexpected events
This outcome concerns the occurence of the adverse events
Measured: at Day0, Day2, Day7, Day21 and Day56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start17 Jan 2022
- Primary completion7 Feb 2022
- Study completion7 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solar LentigoStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cryonove Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- INNOVSOLUTION, CEISO, Dermatech
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05322668
- Sponsor's protocol ID
- (CS4_3)IVYTOP-N°21D588A0003
- Acronym
- AGILE3
- Status last verified
- Mar 2022
- First submitted
- 4 Apr 2022
- Last updated
- 19 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Tolerance of Cyto-selective Difluoroethane-based Cryotherapy
- ClinicalTrials.gov ID
- NCT05322668
- Acronym / sponsor ID
- AGILE3 / (CS4_3)IVYTOP-N°21D588A0003
- Conditions
- Solar Lentigo
- Keywords
- Cryotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Cryonove PharmaIndustry (pharma, biotech, devices)
- Collaborators
- INNOVSOLUTION, CEISO, Dermatech
- Study start
- 17 Jan 2022 (actual)
- Primary completion
- 7 Feb 2022 (actual)
- Study completion
- 7 Feb 2022 (actual)
- First posted
- 12 Apr 2022 (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.
Cryotherapy is more and more used to improve skin appearance. Devices using difluoroethane, manufactured by CRYONOVE PHARMA, are already available on the local and international markets, e.g. CRYOBEAUTY MAINS and CRYOBEAUTY CORPS.
However, the cryogenic gas (conventional cryotherapy - liquid nitrogen) creates a dermabrasion of the skin surface and person receiving this kind of treatment presents an impaired skin during a few days following the treatment as temporary damage of stratum corneum, erythema, scars, burns.
Following the side effects occurring after conventional cryotherapy application, it seems interesting for the sponsor to select other sequences of a cryogenic spray (4 prototypes of devices) which could be used for lentigo treatment with a same benefit for the consumers without any safety outcomes.
This study will assess the use of different prototypes with a sequence of application of cryogenic gas which reaches a higher temperature than those which used with the reference device, in order to increase the acceptability of the device.
(CS4_3) proof of concept, interventional, monocentric, aims to evaluate the tolerance of cryotherapy treatments applied on healthy skin on the back of the hands.
The main objective of the study is to evaluate on phototype V and VI, the tolerance of 4 different conditions of cryotherapy treatments (4 prototypes) applied on healthy skin on the back of the hands.
Detailed description
Prototypes (812A-v1), (812C-v1), (812D-v1) and (812F-v1) will be applied on hands areas by the same order for all volunteers using a reposition mask. On each hand 2 devices will be attributed starting from the middle point of the hand toward to the lateral internal and lateral external edges of the hand. The distance between 2 treatment areas will be 2 cm.
Each area will be treated 1 time during the study at D0. The treatment will starts from right hand with prototypes (812A-v1) and (812C-v1), then left hands with the prototypes (812D-v1) and (812F-v1) .
Prior to any study device application, the dermatologist will assess the adverse events.
The dermatologist will verify that the skin has not been treated by cosmetic products (no presence of cream that could interfere with the treatment) and is dry.
The procedure will take place at the investigation site. An operator previously trained by the dermatologist will apply the study device to the patient's hand.
Subjects will lie down and the device will be administered upside down.
The prototypes will be applied 10 minutes apart so that pain can be measured without interference from application to application.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Condition 1 | Experimental | Device: Prototypes (812A-v1), (812C-v1), (812D-v1) and (812F-v1)All the subjects will receive all the treatment in the same order. The following prototypes will be applied on hands areas: Application of the prototype (812A-v1) at Day 0, Application of the prototype (812C-v1) at Day 0, Application of the prototype (812D-v1) at Day 0, Application of the prototype (812F-v1) at Day 0, |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female or male.
- Ages > 18.
- Phototype V et VI (according with Fitzpatrick scale)
- Agreeing not to be exposed to the sun (or artificial UV) during the study.
- Informed, having undergone a general clinical examination attesting to his/her ability to participate in the study.
Key exclusion criteria (14 listed)
- Having performed cosmetic treatments (exfoliants, scrubs or self-tanners, facials, UV ...) in the month before the start of the study, at the level of the hand.
- Having applied a depraving product in the month prior to the start of the study, at the hands (except cleansing products).
- Having performed cosmetic treatments in a dermatologist (laser, IPL (Intensed pulsed light), peeling, creams, cryotherapy ...), on the hands 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 |
|---|---|---|
| Prototypes (812A-v1), (812C-v1), (812D-v1) and (812F-v1)All the subjects will receive all the treatment in the same order. On each hand 2 devices will be attributed as follow: * Prototypes (812A-v1) will be applied on an area of the back of the patient's right hand, on healthy skin * Prototypes (812C-v1) will be applied on an area of the back of the patient's right hand, on healthy skin * Prototypes (812D-v1) will be applied on an area of the back of the patient's left hand, on healthy skin * Prototypes (812F-v1) will be applied on an area of the back of the patient's left hand, on healthy skin | Device | Condition 1 |
Primary outcome
Change from baseline skin hyperpigmentation
Time frame: Day 0, Day 2, Day 7, Day 21, Day 56
This outcome is a tolerance assessment criteria. Clinical evaluation of hyperpigmentation on each selected and treated area will be performed by a Dermatologist using the Investigator's Global Assessment likert 6 points scale ranged from 0 to 5: 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)
Change from baseline skin hypopigmentation
Time frame: Day 0, Day 2, Day 7, Day 21, Day 56
This outcome is a tolerance assessment criteria. Clinical evaluation of hypopigmentation on each selected and treated area will be performed by a Dermatologist using a likert 5 points scale ranged from 0 to 4: 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.
Change from baseline skin appearance (Edemas, blisters, bubbles, scars, erythema)
Time frame: Day 0, Day 2, Day 7, Day 21, Day 56
his outcome is a tolerance assessment criteria. Clinical visual evaluation of selected area and surrounded spotless skin area around the spot skin will be performed. A likert scale in 5 points (0 to 4) will be used : 0=none; 1=very mild; 2=mild; 3=moderate; 4=severe.
Change from baseline skin sensation (itching, tingling, burning sensations)
Time frame: Day 0, Day 2, Day 7, Day 21, Day 56
This outcome is a tolerance assessment criteria. Clinical visual evaluation of selected lentigo spots and around the spot skin will be performed. A likert scale in 5 points (0 to 4) will be used : 0=none; 1=very mild; 2=mild; 3=moderate; 4=severe.
Post treatment pain
Time frame: Day 0
This outcome is a tolerance assessment criteria. 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.
Other unexpected events
Time frame: at Day0, Day2, Day7, Day21 and Day56
This outcome concerns the occurence of the adverse events
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 19 Aug 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prototypes (812A-v1), (812C-v1), (812D-v1) and (812F-v1) in people with Solar Lentigo, 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 7 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 19 Aug 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?
Change from baseline skin hyperpigmentation (time frame: Day 0, Day 2, Day 7, Day 21, Day 56). The study lists 6 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 19 Aug 2022.