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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Condition 1: | Experimental | Sequence of cryogenic gas (EC14_4osc) |
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| Condition 2: | Experimental | Sequence of cryogenic gas (EC+05_1osc) |
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| Condition 3: | Experimental | Sequence of cryogenic gas (EC+05_2osc) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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
| Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 56, Day 70, Day 84 |
| Measure | Description | Time Frame |
|---|---|---|
| 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).
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Inclusion Criteria:
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;
Reliable methods of contraception are:
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).
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Catherine QUEILLE-ROUSSEL, Dr | Contact | +33 (0)4.92.03.62.40 | catherine.queille-roussel@skinpharma.fr |
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Proof of concept study concerning 3 prototypes of cyto-selective cryotherapy devices corresponding to a modified CE marked medical device (ref: 822-v1).
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| 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). |
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| 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). |
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| Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 56, Day 70, Day 84 |
| ID | Term |
|---|---|
| D007911 | Lentigo |
| D017495 | Hyperpigmentation |
| ID | Term |
|---|---|
| D008548 | Melanosis |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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