LentigoCS5_10BNCT06305897
Evaluation of the Tolerance (Main Objective) and Performance of Cyto-selective Difluoroethane-based Cryotherapy in the Treatment of Brown Spots (Solar and Senile Lentigines, Post-inflammatory Hyperpigmentation) on the Face
A study testing CRYONOVE (EC14_4osc), CRYONOVE (EC+05_1osc) and CRYONOVE (EC+05_2osc) in people with Lentigo and Solar Lentigo, run by Cryonove Pharma.
Trial summary
The goal of this clinical trial is to compare the 3 different prototype of cyto-selective cryotherapy devices (name of the devices : CRYONOVE) use in brown spots on the face of subject from different ethnicities. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Lentigo, Solar Lentigo, Post Inflammatory Hyperpigmentation
- What is being tested?
- CRYONOVE (EC14_4osc), CRYONOVE (EC+05_1osc) and CRYONOVE (EC+05_2osc)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Apr 2024to Dec 2024
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject having signed a written informed consent form (ICF) to participate in the investigation obtained according to ISO 14155:2020 - Good Clinical Practice (GCP);
- Healthy male and female subjects, 18 to 75 years old (inclusive), and Fitzpatrick's skin type (II-VI) (1);
- Subject of Caucasian and or melanin-rich ethnicity skins;
- Subject presenting at least two brown spots on the face with ≥ 3 and ≤ 6 mm in diameter;
- Female subject of non-childbearing potential, defined as woman without uterus and/or both ovaries, surgically sterile (at least 6 months prior to Screening visit) or post-menopausal (at least one year post cessation of menses);
- Female subject of childbearing potential who has been, in the opinion of the Investigator, using an approved method of birth control for at least 1 month prior to Screening visit and agreeing to continue adequate contraception during the entire study period;
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- Reliable methods of contraception are:
- hormonal methods or intrauterine device in use since at least 1 month prior to Screening visit and during the investigation period;
- bilateral tubal ligation since at least 3 months prior to Screening visit and during the investigation period;
- barrier methods in use at least 14 days prior to Screening visit;
- vasectomized partner;
- sexual abstinence defined as refraining from heterosexual intercourse for at least 3 months prior to Screening visit and during the entire period of risk associated with the study products.
- Subject who has not been exposed to UV within at least two months prior to the screening visit and agreeing to avoid exposure to UV radiation (tanning beds, phototherapy and sunlight) for the whole study duration;
- Subject able to comprehend the full nature and the purpose of the investigation, including possible risks and side effects, and subjects able to cooperate with the Investigator and to comply with the requirements of the entire investigation (including ability to attend all the planned investigation visits according to the time limits), based on Investigator's judgement;
- Subject affiliated to a health social security system (according to French Law).
Who cannot join
- Female subject who is pregnant, parturient or breast feeding;
- Female subject of childbearing potential having a positive urinary pregnancy test at Day 0;
- Subject having performed cosmetic treatments (e.g., exfoliants, scrubs or selftanners, facial UV) in the month before the start of the study on the face (see restrictions paragraph);
- Subject having performed cosmetic or aesthetic treatments by a dermatologist (e.g., laser, IPL, peeling, creams, cryotherapy) in the last 6 months on the face;
- Subject receiving systemic or local treatment (e.g., dermocorticoids, corticosteroids, diuretics) likely to interfere with the evaluation of the parameter studied;
- Subject affected by dermatosis, autoimmune disease, systemic, chronic or acute disease, or any other pathology that may interfere with treatment or influence the results of the study (e.g., people with diabetes or circulatory problems, allergic to cold, Raynaud's syndrome);
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- Subject with clinically significant skin condition on the tested area (e.g., active eczema, psoriasis, rosacea, scleroderma, acne, dermatitis) or presence on the tested area of skin lesions, scars, tattoos;
- Concomitant participation in other clinical trials/investigations or participation in the evaluation of any IMD/IP during 2 months before this study;
- Protected subject as defined in the Articles of the French Public Health Code: Article 1121-7: person deprived of liberty by a judicial or administrative decision, or subject to psychiatric care or person admitted to a health or social institution for purposes other than the research. Article 1121-8: adult person subject to a legal protection measure or unable to express his/her consent;
- Subject unable to communicate or cooperate with the Investigator due to poor mental development, language problems or impaired cerebral function;
- Subject currently participating in another clinical study or being in an exclusion period of another clinical study;
- Subject having received 6000 euros indemnities for participation in clinical trials/investigations in the 12 previous months, including participation in the present study (according to French Law).
Trial locations and contacts
No sites are listed yet.
About this study
The goal of this clinical trial is to compare the 3 different prototype of cyto-selective cryotherapy devices (name of the devices : CRYONOVE) use in brown spots on the face of subject from different ethnicities. The main questions it aims to answer are:
- the tolerance of 3 prototypes of cyto-selective cryotherapy treatments
- the performance of 3 prototypes of cyto-selective cryotherapy treatments
Participants will be treated for each spots with a definied prototype during 6 treatment visits.
Researchers will compare the tolerance and performance of the 3 prototypes.
- Conditions
- Lentigo, Solar Lentigo, Post Inflammatory Hyperpigmentation
- Being tested
- CRYONOVE (EC14_4osc), CRYONOVE (EC+05_1osc), CRYONOVE (EC+05_2osc)
- Keywords
- cryotherapy, brown spots
- Medical subject headings
- Lentigo, Hyperpigmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRYONOVE (EC14_4osc)Device
The prototype is a variant version from that of a CE marked MD already commercialized (Cryobeauty mains, Cryobeauty Pharma SAS, France) which produces a cryogenic spray sequence (EC14). The prototype is intended to treat pigmented spots of the face (PIH spots and senile and solar lentigos).
CRYONOVE (EC+05_1osc)Device
The prototype is a variant version from that of a CE marked MD already commercialized (Cryobeauty mains, Cryobeauty Pharma SAS, France) which produces a cryogenic spray sequence (EC05_1osc). The prototype is intended to treat pigmented spots of the face (PIH spots and senile and solar lentigos).
CRYONOVE (EC+05_2osc)Device
The prototype is a variant version from that of a CE marked MD already commercialized (Cryobeauty mains, Cryobeauty Pharma SAS, France) which produces a cryogenic spray sequence (EC05_2osc). The prototype is intended to treat pigmented spots of the face (PIH spots and senile and solar lentigos).
| Study group | Role | What they receive |
|---|---|---|
| Condition 1: | Experimental | Sequence of cryogenic gas (EC14_4osc) Receives: Device: CRYONOVE (EC14_4osc) |
| Condition 2: | Experimental | Sequence of cryogenic gas (EC+05_1osc) Receives: Device: CRYONOVE (EC+05_1osc) |
| Condition 3: | Experimental | Sequence of cryogenic gas (EC+05_2osc) Receives: Device: CRYONOVE (EC+05_2osc) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerance
The primary objective of this clinical investigation is to evaluate the tolerance (IGA scale) of 3 prototypes of cyto-selective cryotherapy treatments applied on the brown spots on the face of subject from different ethnicities (Caucasian and melanin-rich skins). A brown spot is defined as solar or senile lentigo (SSL) and post-inflammatory hyperpigmentation (PIH).
-> IGA Scale : Investigator's Global Assessment - 6 points - Scale in 6 points (0 to 5) 0 = clear of hyperpigmentation
- = almost clear of hyperpigmentation
- = mild, but noticeable hyperpigmentation
- = moderate hyperpigmentation (medium brown in quality)
- = severe hyperpigmentation (dark brown in quality)
- = very severe hyperpigmentation (very dark brown, almost black in quality)
Measured: Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 56, Day 70, Day 84
Secondary outcomes (1)
Performance
The secondary objective of this clinical investigation is to evaluate the performance of 3 prototypes of cyto-selective cryotherapy treatments applied on the brown spots on the face of subject from different ethnicities (Caucasian and melanin-rich skins).
- Standardized photographs will be taken before the treatment at each visit (C-cube).
- Color Chart (color and lightness) only for Caucasian skins.
Measured: Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 56, Day 70, Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study startApr 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Proof of concept study concerning 3 prototypes of cyto-selective cryotherapy devices corresponding to a modified CE marked medical device (ref: 822-v1).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cryonove Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06305897
- Sponsor's protocol ID
- CS5_10B
- Acronym
- CS5_10B
- Status last verified
- Apr 2024
- First submitted
- 28 Feb 2024
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Tolerance (Main Objective) and Performance of Cyto-selective Difluoroethane-based Cryotherapy in the Treatment of Brown Spots (Solar and Senile Lentigines, Post-inflammatory Hyperpigmentation) on the Face
- ClinicalTrials.gov ID
- NCT06305897
- Acronym / sponsor ID
- CS5_10B / CS5_10B
- Conditions
- Lentigo, Solar Lentigo, Post Inflammatory Hyperpigmentation
- Keywords
- cryotherapy, brown spots
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Cryonove PharmaIndustry (pharma, biotech, devices)
- Study start
- Apr 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 12 Mar 2024 (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.
The goal of this clinical trial is to compare the 3 different prototype of cyto-selective cryotherapy devices (name of the devices : CRYONOVE) use in brown spots on the face of subject from different ethnicities. The main questions it aims to answer are:
- the tolerance of 3 prototypes of cyto-selective cryotherapy treatments
- the performance of 3 prototypes of cyto-selective cryotherapy treatments
Participants will be treated for each spots with a definied prototype during 6 treatment visits.
Researchers will compare the tolerance and performance of the 3 prototypes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Proof of concept study concerning 3 prototypes of cyto-selective cryotherapy devices corresponding to a modified CE marked medical device (ref: 822-v1).
| Arm | Type | Receives |
|---|---|---|
| Condition 1: | Experimental | Device: CRYONOVE (EC14_4osc)Sequence of cryogenic gas (EC14_4osc) |
| Condition 2: | Experimental | Device: CRYONOVE (EC+05_1osc)Sequence of cryogenic gas (EC+05_1osc) |
| Condition 3: | Experimental | Device: CRYONOVE (EC+05_2osc)Sequence of cryogenic gas (EC+05_2osc) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Subject having signed a written informed consent form (ICF) to participate in the investigation obtained according to ISO 14155:2020 - Good Clinical Practice (GCP);
- Healthy male and female subjects, 18 to 75 years old (inclusive), and Fitzpatrick's skin type (II-VI) (1);
- Subject of Caucasian and or melanin-rich ethnicity skins;
- Subject presenting at least two brown spots on the face with ≥ 3 and ≤ 6 mm in diameter;
- Female subject of non-childbearing potential, defined as woman without uterus and/or both ovaries, surgically sterile (at least 6 months prior to Screening visit) or post-menopausal (at least one year post cessation of menses);
Key exclusion criteria (12 listed)
- Female subject who is pregnant, parturient or breast feeding;
- Female subject of childbearing potential having a positive urinary pregnancy test at Day 0;
- Subject having performed cosmetic treatments (e.g., exfoliants, scrubs or selftanners, facial UV) in the month before the start of the study on the face (see restrictions paragraph);
- Subject having performed cosmetic or aesthetic treatments by a dermatologist (e.g., laser, IPL, peeling, creams, cryotherapy) in the last 6 months on the face;
- Subject receiving systemic or local treatment (e.g., dermocorticoids, 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 |
|---|---|---|
| CRYONOVE (EC14_4osc)The prototype is a variant version from that of a CE marked MD already commercialized (Cryobeauty mains, Cryobeauty Pharma SAS, France) which produces a cryogenic spray sequence (EC14). The prototype is intended to treat pigmented spots of the face (PIH spots and senile and solar lentigos). | Device | Condition 1: |
| CRYONOVE (EC+05_1osc)The prototype is a variant version from that of a CE marked MD already commercialized (Cryobeauty mains, Cryobeauty Pharma SAS, France) which produces a cryogenic spray sequence (EC05_1osc). The prototype is intended to treat pigmented spots of the face (PIH spots and senile and solar lentigos). | Device | Condition 2: |
| CRYONOVE (EC+05_2osc)The prototype is a variant version from that of a CE marked MD already commercialized (Cryobeauty mains, Cryobeauty Pharma SAS, France) which produces a cryogenic spray sequence (EC05_2osc). The prototype is intended to treat pigmented spots of the face (PIH spots and senile and solar lentigos). | Device | Condition 3: |
Primary outcome
Tolerance
Time frame: Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 56, Day 70, Day 84
The primary objective of this clinical investigation is to evaluate the tolerance (IGA scale) of 3 prototypes of cyto-selective cryotherapy treatments applied on the brown spots on the face of subject from different ethnicities (Caucasian and melanin-rich skins). A brown spot is defined as solar or senile lentigo (SSL) and post-inflammatory hyperpigmentation (PIH). -> IGA Scale : Investigator's Global Assessment - 6 points - Scale in 6 points (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)
1 secondary outcome
Performance
Time frame: Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 56, Day 70, Day 84
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing CRYONOVE (EC14_4osc), CRYONOVE (EC+05_1osc) and CRYONOVE (EC+05_2osc) in people with Lentigo and Solar Lentigo, run by Cryonove Pharma.
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 15 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Catherine QUEILLE-ROUSSEL, Dr (+33 (0)4.92.03.62.40, catherine.queille-roussel@skinpharma.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerance (time frame: Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 56, Day 70, Day 84). 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 17 Apr 2024.