CompletedNot Applicable

Tolerance and Performance of Cyto-selective Difluoroethane-based Cryotherapy in the Treatment of Brown Spots

Georgia33 participantsStarted 2022-10-21

Plain-language summary

CS5\_1 study aim to evaluate the tolerance and to adjust the mode of administration of 4 different conditions of cryotherapy treatments applied on the brown spots of the face and hand with 3 prototypes. Each treatment corresponds to a combination of a specific sequence of a cryogenic spray and of a frequency of application. The study will evaluate 3 prototypes : * Prototype 1 : from (815-v1 001) to (815-v1 100) * Prototype 2 : from (815-v1 101) to (815-v1 150) * Prototype 3 : from (815-v1 151) to (815-v1 200)

Who can participate

Age range30 Years – 75 Years

SexALL

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: * Female or male. * Ages 30 to 75. * Phototypes I to IV (according with Fitzpatrick scale). * Featuring brown spots (solar lentigos, senile lentigo) on the face and hands ≥ 3 and ≤ 6 mm in diameter (at least 4 spots per subject for phototypes II and III and no specific requirements re accurate number of spots for phototypes I and IV).). * Agreeing not to be exposed to the sun (or artificial UV) during the study. * Informed, having undergone a general clinical examination attesting to his/her ability to participate in the study. * Having given written consent for their participation in the study. * No suspicion of carcinoma after investigation by a dermatologist. Exclusion Criteria: * Having performed cosmetic treatments (exfoliants, scrubs or self-tanners, manicures, facials, UV ...) in the month before the start of the study, at the level of the face and the hands. * Having applied a depraving product in the month prior to the start of the study, at the level of the face and the hands. * Having performed cosmetic treatments in a dermatologist (laser, Intense Pulsed Light (IPL) , peeling, creams, cryotherapy ...), at the level of the face and the hands in the last 6 months. * With dermatosis, autoimmune disease, systemic, chronic or acute disease, or any other pathology that may interfere with treatment or influence the results of the study (people with diabetes or circulatory problems, allergic to cold, Raynaud's syndrome...). * Receiving treatment by …

What they're measuring

Change from baseline skin hyperpigmentation

Timeframe: Day 0, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 70,Day 84 and Day 0 + 6 months

Change from baseline skin hypopigmentation

Timeframe: Day 0, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 70,Day 84 and Day 0 + 6 months

Change from baseline skin appearance

Timeframe: Day 0, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 70,Day 84 and Day 0 + 6 months

Change from baseline skin sensation

Timeframe: Day 0, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 70,Day 84 and Day 0 + 6 months

Self-assesment of pain by VAS

Timeframe: Day 0

Change from baseline spots visibility

Timeframe: Day 0, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 70,Day 84 and Day 0 + 6 months

Trial details

NCT IDNCT05600049

SponsorCryonove Pharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-06-08

View on ClinicalTrials.gov More Lentigo Solar trials

Plain-language summary

Who can participate

Age range30 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change from baseline skin hyperpigmentation

Timeframe: Day 0, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 70,Day 84 and Day 0 + 6 months

Change from baseline skin hypopigmentation

Timeframe: Day 0, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 70,Day 84 and Day 0 + 6 months

Change from baseline skin appearance

Timeframe: Day 0, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 70,Day 84 and Day 0 + 6 months

Change from baseline skin sensation

Timeframe: Day 0, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 70,Day 84 and Day 0 + 6 months

Self-assesment of pain by VAS

Timeframe: Day 0

Change from baseline spots visibility

Timeframe: Day 0, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 70,Day 84 and Day 0 + 6 months