CS5\_8 study aim to evaluate the tolerance and to adjust the mode of administration of 2 different conditions of cryotherapy treatments applied on the brown spots of the face with 1 prototype (816-v1). Each treatment corresponds to a specific frequency of cryogenic spray application. The study will evaluate the following prototype : • Prototypes from (816-v1 301) to (816-v1 355)
Rational : Solar/senile lentigo is a harmless patch of darkened skin. It results from exposure to ultraviolet (UV) radiation, which causes local proliferation of melanocytes and accumulation of melanin within the skin cells (keratinocytes). Solar/senile lentigos or lentigines are very common, especially in people over the age of 40 years. Solar/senile lentigines are found as groups of similar lesions on sun-exposed sites, particularly the face or the back of hands. Cryotherapy is more and more used to improve skin appearance and currently used to treat lentigo spot. However, the cryogenic gas (conventional cryotherapy - liquid nitrogen) creates a dermabrasion of the skin surface and person receiving this kind of treatment presents an impaired skin during a few days following the treatment as temporary damage of stratum corneum, erythema, scars, burns. Following the side effects occurring after conventional cryotherapy application, the Sponsor has developed some devices using difluoroethane, manufactured by CRYONOVE PHARMA, already available on the local and international markets, e.g. CRYOBEAUTY MAINS and CRYOBEAUTY CORPS. To continue it research and development activities, the sponsor selected other sequences of a cryogenic spray (1 prototype of devices for face used according to different frequencies of application, i.e. 2 conditions evaluated) which could be used for lentigo treatment with a same benefit for the consumers without any safety outcomes. Design: The study performed is a proof of performance designed to be exploratory, interventional study, monocentric, randomized and double blinded. Intervention : 1 prototype of devices are evaluated in 2 different conditions. Each treatment corresponds to a specific frequency of cryogenic spray application. A total of 42 brown spots are needed (at least 1 brown spot on the face).The 42 brown spots will be randomized between the 2 conditions and will be attributed to subjects according to the number of spots identified by Investigator. Prototypes (816-v1 301) to (816-v1 355) will be applied on brown pots located on the face. Each spot will be treated six times by a defined prototype (always the same device on the same spot all along the study) according to specific frequencies (every week or every two weeks). Prior to any study device application, the dermatologist will assess the adverse events and will decide if the period between two consecutive applications should be extended or not.The dermatologist will verify that the skin has not been treated by cosmetic products (no presence of cream that could interfere with the treatment) and is dry. As the study will use prototypes, before each treatment, the prototype will be administered to any surface (in order to purge eventually the presence of air). An operator previously trained by the dermatologist will apply the study device to the patient's face. Subjects will be lying down, and the device will be administered upside down. During applications on the face, subjects will wear diving goggles protecting the eyes from cryogenic gas. The patient follow-up visits are from Day 0 to 6 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
Application on brown spots located on the face (6 treatments during the study). An operator previously trained by the dermatologist will apply the study device to the patient's face. Subjects will be lying down, and the prototypes will be administered upside down. During applications, subjects will wear diving goggles protecting the eyes from cryogenic gas.
Application on brown spots located on the face (6 treatments during the study). An operator previously trained by the dermatologist will apply the study device to the patient's face. Subjects will be lying down, and the prototypes will be administered upside down. During applications, subjects will wear diving goggles protecting the eyes from cryogenic gas.
Ltd "Health"
Batumi, Georgia
Change from baseline skin hyperpigmentation
The evaluation will be performed visually on the selected spots. A scale in 6 points (0 to 5) will be used : 0=Clear of hyperpigmentation; 1. Almost clear of hyperpigmentation; 2. mild, but noticeable hyperpigmentation; 3. moderate hyperpigmentation (medium brown in quality); 4. severe hyperpigmentation (dark brown in quality); 5. very severe hyperpigmentation (very dark brown, almost black in quality).
Time frame: Day 0, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 56, Day 70, Day 84 and Day 0 + 6 months
Change from baseline skin hypopigmentation
The evaluation will be performed visually on the selected spots. A scale in 5 points will be used (0 to 4): 0=no hypopigmented lesion; 1. very slight area of hypopigmentation of very small size and very slightly fairer than the surrounding skin; 2. slight area of hypopigmentation of small size and slightly fairer than the surrounding skin; 3. moderate : area of hypopigmentation of moderate size and much fairer than the surrounding skin; 4. severe : area of hypopigmentation of large size and much fairer than the surrounding skin.
Time frame: Day 0, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 56, Day 70, Day 84 and Day 0 + 6 months
Change from baseline skin appearance
The evaluation will be performed visually on the selected spots and surrounded spotless skin area around the spot skin to assess erythema, oedema blister, bubble, scars, micro-bruise, hematoma, dryness,desquamation, fissures/cracks, roughness,crust, pink spots and papules. A scale in 5 points (0 to 4) will be used : 0=none; 1. very mild; 2. mild; 3. moderate; 4. severe.
Time frame: Day 0, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 56, Day 70, Day 84 and Day 0 + 6 months
Change from baseline skin sensation
The evaluation will be performed visually on the selected spots and around the spot skin to assess tightness, stinging, itching, warm and burning sensation. A scale in 5 points (0 to 4) will be used : 0=none; 1. very mild; 2. mild; 3. moderate; 4. severe.
Time frame: 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
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Self-assesment of pain by VAS
The pain of the treatment will be assessed by the Visual Analogue Scale (VAS) at time T0 on the treated area. The pain assessed is that felt during the application of the devices. It will be collected from the patient within 5 minutes of application. The VAS is made up of a 10-centimeter line anchored by two ends of the pain. 10 is the first end being the "maximum pain imaginable" and 0 is the other end being "no pain".
Time frame: 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 spots visibility
Standardized photographs will be taken using a Dermatoscope C-Cube® (PIXIENCE) which allows realizing high resolution skin pictures. The capture will be taken on the previously selected lentigo and a spotless area.
Time frame: 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 spots color
L'OREAL Color-Chart is a visual mode of evaluation chart which includes 4 items : * Color of lentigo spot * Lightness of lentigo spot * Color of spotless area * Lightness of spotless area The items color of lentigo spot and color of spotless area are using a scale redder to yellower in 7 points (G to M). The items lightness of lentigo spot and lightness of spotless are using a scale lighter to darker in 15 points (5 to 19)
Time frame: 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 lentigines global improvement scale (LGIS) score
Lentigines Global Improvement Scale (LGIS) score will be used to assess the spots visibility This is a 7-point scale : * Completely clear - 0 - : No evidence of hyperpigmentation 100% improvement * Almost clear - 1 - : Very significant clearance (about 90%); only minor evidence of hyperpigmentation remains * Marked improvement - 2 - : Significant improvement (about 75%); score evidence of hyperpigmentation remains * Moderate improvement - 3 - : intermediate between marked and slight improvement; about 50% improvement in the appearance of hyperpigmentation * Slight improvement - 4 - : some improvement (about 25%); however significant evidence of hyperpigmentation remains * No change - 5 - : Hyperpigmentation has not changed since baseline * Worse - 6 - : Worse (hyperpigmentation is worse that at baseline)
Time frame: Day 49 and Day 84
Self assessment of skin appearance
The skin appearance will be assessed by subjects through a 3 items questionnaire. It allows obtaining the subjective appraisal of subject on the treatments using the following 5-point scale: * agree, * quite agree * neither agree, nor disagree * quite disagree * disagree. The items are the following: * The spot seems clearer. * The size of the spot seems reduced. * The spot seems less visible.
Time frame: 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