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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 | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGNA

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

NCT06305897•Cryonove Pharma

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Yes

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;
+5 more criteria

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;
+2 more criteria

Key Dates

Start Date

April 1, 2024

Primary Completion Date

December 1, 2024

Completion Date

December 1, 2024

Last Updated

April 17, 2024

Enrollment

ESTIMATED participants

Conditions

LentigoSolar LentigoPost Inflammatory Hyperpigmentation

Interventions

CRYONOVE (EC14_4osc)

DEVICE

CRYONOVE (EC+05_1osc)

DEVICE

CRYONOVE (EC+05_2osc)

DEVICE

Contacts

Catherine QUEILLE-ROUSSEL, Dr

CONTACT

+33 (0)4.92.03.62.40 catherine.queille-roussel@skinpharma.fr

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 17, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

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Complications and Recurrences After Mohs Micrographic Surgery and Slow Mohs

Safety and Efficacy of High-Intensity Macrofocused Ultrasound for Solar Lentigo in Chinese Population

Performance and Tolerance of Cyto-selective Difluoroethane-based Cryotherapy in th Treatment of Brown Spots (Solar and Senile Lentigines, Post-Inflammatory Hyperpigmentation) on the Face and Hands of Asian Ethnicity Skins

Tolerance and Performance of Cyto-selective Difluoroethane-based Cryotherapy in the Treatment of Brown Spots (Solar and Senile Lentigines, Post-Inflammatory Hyperpigmentation)

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