Phase
Condition
Sun Poisoning
Treatment
CRYONOVE (EC05osc)
CRYONOVE (EC14_4osc)
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Having signed a written informed consent form (ICF) to participate in theinvestigation obtained according to ISO 14155:2020 - Good Clinical Practice (GCP);
Healthy male and female participants, 18 to 75 years old (inclusive), andFitzpatrick'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 bothovaries, surgically sterile (at least 6 months prior to Screening visit) orpost-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 Screeningvisit and agreeing to continue adequate contraception during the entire studyperiod; Reliable methods of contraception are:
hormonal methods or intrauterine device in use since at least 1 month prior toScreening visit and during the investigation period;
bilateral tubal ligation since at least 3 months prior to Screening visit andduring 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 atleast 3 months prior to Screening visit and during the entire period of riskassociated with the study products.
Participant who has not been exposed to UV within at least two months prior to thescreening visit and agreeing to avoid exposure to UV radiation (tanning beds,phototherapy and sunlight) for the whole study duration. A sun-protection cream willbe distributed to the participants to use in case of sun exposure;
Having undergone a general clinical examination attesting to his/her ability toparticipate 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 theInvestigator and to comply with the requirements of the entire investigation (including ability to attend all the planned investigation visits according to thetime limits), based on Investigator's judgement;
No suspicion of carcinoma after investigation by a dermatologist
Exclusion
Exclusion Criteria:
Female participant who is pregnant, parturient or breast feeding;
Female participant of childbearing potential having a positive urinary pregnancytest at Day 0;
Having performed cosmetic treatments (e.g., exfoliants, scrubs or self-tanners,facial UV) in the month before the start of the study on the face (see restrictionsparagraph);
Having performed cosmetic or aesthetic treatments by a dermatologist (e.g., laser,IPL, peeling, creams, cryotherapy) in the last 6 months on the face;
Receiving systemic or local treatment (e.g., dermocorticoids, corticosteroids,diuretics) likely to interfere with the evaluation of the parameter studied;
Person affected by dermatosis, autoimmune disease, systemic, chronic or acutedisease, or any other pathology that may interfere with treatment or influence theresults of the study (e.g., people with diabetes or circulatory problems, allergicto cold, Raynaud's syndrome);
Person with clinically significant skin condition on the tested area (e.g., activeeczema, psoriasis, rosacea, scleroderma, acne, dermatitis) or presence on the testedarea of skin lesions, scars, tattoos;
Concomitant participation in other clinical trials/investigations or participationin the evaluation of any IMD/IP during 2 months before this study;
Unable to follow the requirements of the protocol.Vulnerable: whose ability orfreedom to give or refuse consent is limited.
Major protected by law (tutorship, curatorship, safeguarding justice...).
Unable to be contacted urgently over the phone.
Unable to communicate or cooperate with the Investigator due to poor mentaldevelopment, language problems (unable to read and write English language) orimpaired cerebral function;
Currently participating in another clinical study or being in an exclusion period ofanother clinical study;
Study Design
Connect with a study center
SMU - Photobiology Laboratory, Sefako Makgatho Health Sciences University
Pretoria,
South AfricaSite Not Available
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