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| Name | Class |
|---|---|
| Dermatech | INDUSTRY |
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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:
Researchers will compare the tolerance and performance of the 3 prototypes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (EC14_4osc) | Experimental | (EC14_4osc) 1 application every week for a total of 6 applications |
|
| (EC-05_1osc) | Experimental | (EC-05_1osc) 1 application every two weeks for a total of 6 applications |
|
| 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 | 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
| [Time Frame: Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 56, Day 70] |
| Measure | Description | Time Frame |
|---|---|---|
| Performance (Acquisitions C-cube) | --> Performance assesment : • Standardized photographs will be taken before the treatment at each visit (C-Cube acquisition without analysis) - illustration only | [Time Frame: Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 56, Day 70] |
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Inclusion Criteria:
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;
Reliable methods of contraception are:
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Victoria DAUPHANT | Dermatech | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SMU - Photobiology Laboratory, Sefako Makgatho Health Sciences University | Pretoria | South Africa |
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Proof of concept study concerning 2 prototypes of cyto-selective cryotherapy devices corresponding to a modified CE marked medical device (ref: 822-v1).
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Double blind (participant and care provider)
|
| 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). |
|
| 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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