Evaluation of the Tolerance (Main Objective) and Performance of Cyto-selective Difluoroethane-bas… (NCT06305897) | Clinical Trial Compass
UnknownNot Applicable
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
45 participantsStarted 2024-04
Plain-language 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. 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Tolerance
Timeframe: Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 56, Day 70, Day 84
. 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;
Exclusion criteria
. 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);
. 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;