LentigoCS5_10NCT06361251
Interventional, Monocentric, Double-blind Randomized Category 2b Study Evaluating the Evaluation of the Tolerance of Cyto-selective Difluoroethane-based Cryotherapy in the Treatment of Brown Spots (Solar and Senile Lentigines, Post -Inflammatory Hyperpigmentation (Pih)) on the Face
A study testing CRYONOVE (EC14_4osc) and CRYONOVE (EC05osc) in people with Lentigo and Solar Lentigo, run by Cryonove Pharma at 1 site in South Africa.
Trial summary
The goal of this clinical trial is to compare the 2 different prototype of cytoselectivecryotherapy 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 years
- Conditions the study is for
- Lentigo, Solar Lentigo, Post Inflammatory Hyperpigmentation
- What is being tested?
- CRYONOVE (EC14_4osc) and CRYONOVE (EC05osc)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Africa
- Study dates
- 16 Sep 2024to 12 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 participants, 18 to 75 years old (inclusive), and Fitzpatrick's skin type (V-VI);
- Melanin-rich ethnicity skins;
- Presenting at least two brown spots on the face with ≥ 3 and ≤ 6 mm in diameter;
- Female 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 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.
- Participant 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. A sun-protection cream will be distributed to the participants to use in case of sun exposure;
- Having undergone a general clinical examination attesting to his/her ability to participate in the study.
- Participant able to comprehend the full nature and the purpose of the investigation, including possible risks and side effects, and 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;
- No suspicion of carcinoma after investigation by a dermatologist
Who cannot join
- Female participant who is pregnant, parturient or breast feeding;
- Female participant of childbearing potential having a positive urinary pregnancy test at Day 0;
- Having performed cosmetic treatments (e.g., exfoliants, scrubs or self-tanners, facial UV) in the month before the start of the study on the face (see restrictions paragraph);
- Having performed cosmetic or aesthetic treatments by a dermatologist (e.g., laser, IPL, peeling, creams, cryotherapy) in the last 6 months on the face;
- Receiving systemic or local treatment (e.g., dermocorticoids, corticosteroids, diuretics) likely to interfere with the evaluation of the parameter studied;
- Person 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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- Person 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;
- 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...).
- Unable to be contacted urgently over the phone.
- Unable to communicate or cooperate with the Investigator due to poor mental development, language problems (unable to read and write English language) or impaired cerebral function;
- Currently participating in another clinical study or being in an exclusion period of another clinical study;
Trial locations and contacts
1 site in 1 country.
South Africa1 site
SMU - Photobiology Laboratory, Sefako Makgatho Health Sciences University
Pretoria
About this study
The goal of this clinical trial is to compare the 2 different prototype of cytoselectivecryotherapy 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 2 prototypes of cyto-selective cryotherapy treatments
- the performance of 2 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 (EC05osc)
- 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 (EC05osc)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). The prototype is intended to treat pigmented spots of the face (PIH spots and senile and solar lentigos).
| Study group | Role | What they receive |
|---|---|---|
| (EC14_4osc) | Experimental | (EC14_4osc) 1 application every week for a total of 6 applications Receives: Device: CRYONOVE (EC14_4osc) |
| (EC-05_1osc) | Experimental | (EC-05_1osc) 1 application every two weeks for a total of 6 applications Receives: Device: CRYONOVE (EC05osc) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerance
Evaluate the evolution of the scores given by the dermatologist or the participant on the following items :
Hyperpigmentation (IGA scale)* Hypopigmentation Erythema, oedema, micro-bruise, hematoma, dryness, desquamation, fissures / cracks, roughness, crust Skin sensation (tightness, stinging, itching, warm and burning sensations) Day 0: Pain after each treatment (5 min. rest between two treatments) Other unexpected events
*: IGA Scale : Investigator's Global Assessment - 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: [Time Frame: Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 56, Day 70]
Secondary outcomes (1)
Performance (Acquisitions C-cube)
--> Performance assesment :
- Standardized photographs will be taken before the treatment at each visit (C-Cube acquisition without analysis) - illustration only
Measured: [Time Frame: Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 56, Day 70]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start16 Sep 2024
- Primary completion12 Dec 2024
- Study completion12 Dec 2024
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 2 prototypes of cyto-selective cryotherapy devices corresponding to a modified CE marked medical device (ref: 822-v1).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cryonove Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dermatech
- Responsible party
- Sponsor
- Investigators
- Victoria DAUPHANT, Study chair, Dermatech
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06361251
- Sponsor's protocol ID
- CS5_10
- Acronym
- CS5_10
- Status last verified
- Dec 2024
- First submitted
- 2 Apr 2024
- Last updated
- 24 Dec 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 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional, Monocentric, Double-blind Randomized Category 2b Study Evaluating the Evaluation of the Tolerance of Cyto-selective Difluoroethane-based Cryotherapy in the Treatment of Brown Spots (Solar and Senile Lentigines, Post -Inflammatory Hyperpigmentation (Pih)) on the Face
- ClinicalTrials.gov ID
- NCT06361251
- Acronym / sponsor ID
- CS5_10 / CS5_10
- Conditions
- Lentigo, Solar Lentigo, Post Inflammatory Hyperpigmentation
- Keywords
- cryotherapy, brown spots
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cryonove PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Dermatech
- Study start
- 16 Sep 2024 (actual)
- Primary completion
- 12 Dec 2024 (actual)
- Study completion
- 12 Dec 2024 (actual)
- First posted
- 11 Apr 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 2 different prototype of cytoselectivecryotherapy 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 2 prototypes of cyto-selective cryotherapy treatments
- the performance of 2 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
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Proof of concept study concerning 2 prototypes of cyto-selective cryotherapy devices corresponding to a modified CE marked medical device (ref: 822-v1).
| Arm | Type | Receives |
|---|---|---|
| (EC14_4osc) | Experimental | Device: CRYONOVE (EC14_4osc)(EC14_4osc) 1 application every week for a total of 6 applications |
| (EC-05_1osc) | Experimental | Device: CRYONOVE (EC05osc)(EC-05_1osc) 1 application every two weeks for a total of 6 applications |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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 participants, 18 to 75 years old (inclusive), and Fitzpatrick's skin type (V-VI);
- Melanin-rich ethnicity skins;
- Presenting at least two brown spots on the face with ≥ 3 and ≤ 6 mm in diameter;
- Female 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 (13 listed)
- Female participant who is pregnant, parturient or breast feeding;
- Female participant of childbearing potential having a positive urinary pregnancy test at Day 0;
- Having performed cosmetic treatments (e.g., exfoliants, scrubs or self-tanners, facial UV) in the month before the start of the study on the face (see restrictions paragraph);
- Having performed cosmetic or aesthetic treatments by a dermatologist (e.g., laser, IPL, peeling, creams, cryotherapy) in the last 6 months on the face;
- 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 | (EC14_4osc) |
| CRYONOVE (EC05osc)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). The prototype is intended to treat pigmented spots of the face (PIH spots and senile and solar lentigos). | Device | (EC-05_1osc) |
Primary outcome
Tolerance
Time frame: [Time Frame: Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 56, Day 70]
Evaluate the evolution of the scores given by the dermatologist or the participant on the following items : Hyperpigmentation (IGA scale)* Hypopigmentation Erythema, oedema, micro-bruise, hematoma, dryness, desquamation, fissures / cracks, roughness, crust Skin sensation (tightness, stinging, itching, warm and burning sensations) Day 0: Pain after each treatment (5 min. rest between two treatments) Other unexpected events *: IGA Scale : Investigator's Global Assessment - 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 (Acquisitions C-cube)
Time frame: [Time Frame: Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 56, Day 70]
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 24 Dec 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.
Victoria DAUPHANT study chair
Dermatech
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CRYONOVE (EC14_4osc) and CRYONOVE (EC05osc) in people with Lentigo and Solar Lentigo, run by Cryonove Pharma at 1 site in South Africa.
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 16 inclusion and 13 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 24 Dec 2024. 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 South Africa. 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?
Tolerance (time frame: [Time Frame: Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 56, Day 70]). 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 24 Dec 2024; AzTrials last refreshed its copy on 27 Oct 2026.