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

Launched by CRYONOVE PHARMA · Mar 5, 2024

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment for brown spots on the face, which can happen due to sun exposure or aging. The researchers want to compare three different types of cryotherapy devices, called CRYONOVE, to see how well they work and how comfortable they are for patients. Cryotherapy is a procedure that uses cold temperatures to treat skin issues. Participants in the trial will receive treatments for their brown spots over six visits, and the team will look at how each device performs and how well people tolerate the treatments.

To join the study, participants need to be healthy adults aged 18 to 75 with specific skin types and at least two brown spots on their face. They should also avoid sun exposure and certain cosmetic treatments for a while before and during the study. It's important for participants to attend all scheduled visits and understand the purpose of the trial, including any potential risks. This study is not yet recruiting participants, but it aims to help improve future treatments for brown spots on the skin.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subject having signed a written informed consent form (ICF) to participate in the investigation obtained according to ISO 14155:2020 - Good Clinical Practice (GCP);
• • 2. Healthy male and female subjects, 18 to 75 years old (inclusive), and Fitzpatrick's skin type (II-VI) (1);
• • 3. Subject of Caucasian and or melanin-rich ethnicity skins;
• • 4. Subject presenting at least two brown spots on the face with ≥ 3 and ≤ 6 mm in diameter;
• • 5. 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);
• • 6. 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:
• • 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.
• • 7. 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;
• • 8. 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;
• • 9. Subject affiliated to a health social security system (according to French Law).
• Exclusion Criteria:
• • 1. Female subject who is pregnant, parturient or breast feeding;
• • 2. Female subject of childbearing potential having a positive urinary pregnancy test at Day 0;
• • 3. 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);
• • 4. 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;
• • 5. Subject receiving systemic or local treatment (e.g., dermocorticoids, corticosteroids, diuretics) likely to interfere with the evaluation of the parameter studied;
• • 6. 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);
• • 7. 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;
• • 8. Concomitant participation in other clinical trials/investigations or participation in the evaluation of any IMD/IP during 2 months before this study;
• • 9. 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;
• • 10. Subject unable to communicate or cooperate with the Investigator due to poor mental development, language problems or impaired cerebral function;
• • 11. Subject currently participating in another clinical study or being in an exclusion period of another clinical study;
• • 12. 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).