UnknownNot Applicable

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

South Africa80 participantsStarted 2023-06-10

Plain-language summary

CS5\_7 study aim to evaluate the tolerance and to adjust the mode of administration of two conditions of cryotherapy treatment applied on the brown spots of the face and hands with 1 prototype (816-v1). A brown spot is defined as solar or senile lentigo and post-inflammatory hyperpigmentation (PIH). The study will evaluate the following prototype : • Prototypes from (816-v1 201) to (816-v1 290)

Who can participate

Age range18 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 18 to 75. * Phototypes V and VI (according with Fitzpatrick scale), according to the spots' distribution table. * Featuring brown spots ≥ 3 and ≤ 6 mm in diameter (on the face (and when possible, on the hands). * 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 (only nails care acceptable), facials, UV ...) in the month before the start of the study, at the level of the face and/or hands. * Having applied a depilatoring product in the month prior to the start of the study, on the face and/or hands. * Having performed cosmetic treatments in a dermatologist (laser, Intense Pulsed Light (IPL), peeling, creams, cryotherapy ...), on the face and/or 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 general or local (dermo corticoids, corticosteroids, diuretics ...) likely to interfere with the eval…

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 63, Day 70, Day 77, 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 63, Day 70, Day 77, 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 63, Day 70, Day 77, 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 63, Day 70, Day 77, 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 63, Day 70, Day 77, Day 84 and Day 0 + 6 months

Incidence of unexpected events

Timeframe: Day 0, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 63, Day 70, Day 77, Day 84 and Day 0 + 6 months

Trial details

NCT IDNCT05883657

SponsorCryonove Pharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-12-12

Contact for this trial

Jean-Christophe ANTON

+33 6 80 23 61 13 jc.anton@cryonovepharma.com

View on ClinicalTrials.gov More Solar Lentigo trials

Plain-language summary

Who can participate

Age range18 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 63, Day 70, Day 77, 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 63, Day 70, Day 77, 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 63, Day 70, Day 77, 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 63, Day 70, Day 77, 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 63, Day 70, Day 77, Day 84 and Day 0 + 6 months

Incidence of unexpected events

Timeframe: Day 0, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 63, Day 70, Day 77, Day 84 and Day 0 + 6 months