View clinical trials related to Solar Lentigo.
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The goal of this clinical trial is to compare the 2 different prototype of cytoselectivecryotherapy 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 2 prototypes of cyto-selective cryotherapy treatments - the performance of 2 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.
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.
This trial is a single-center, prospective self-controlled study. The study proposes to recruit 30 patients with solar lentigo on both sides of the face. Patients are randomly assigned to be treated with high-intensity focused ultrasound (MFUS One, Hunan Peninsula Medical Technology Co., Ltd., China) on one side, and the other side is not treated. The Lab* values of the lesion area and the area around the lesion are detected separately using 3nh HIGH-QUALITY COLORMETER colorimeter (Konica-Minolta Company, Japan), and skin lesion images are collected with dermatoscope and VISIA® (Canfield Company, USA). Measurements of Lab* values and related images at the same location, along with adverse events, physician and subjective global aesthetic improvement scale scores are recorded before and at week2, week 4, week6. At the end of the follow-up on the treatment side, the same parameter treatment is provided for the untreated side, and the corresponding observation items are recorded for the patient before treatment, and at week2, week4, and week6 respectively.
CS5_4 study aim to evaluate the performance and the tolerance of 3 prototypes of cyto-selective cryotherapy treatments applied on the brown spots on the face and hands of asian ethnicity skins (chinese). A brown spot is defined as solar or senile lentigo (SSL) and post-inflammatory hyperpigmentation (PIH). Each treatment corresponds to a combination of a specific sequence of cryogenic spray and of a frequency of application. Each spot will be treated by a defined prototype (always the same device on the same spot all along the study). The study will evaluate the following prototype : - Prototypes 1 - Prototypes 2 - Prototypes 3
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)
CS5_3 aims 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 hands with 3 prototypes. A brown spot is defined as solar or senile lentigo and post-inflammatory hyperpigmentation (PIH). 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 : SN from (816-v1 001) to (816-v1 100) - Prototype 2 : SN from (816-v1 101) to (816-v1 150) - Prototype 3 : SN from (816-v1 151) to (816-v1 200) Prototypes will be applied on the face and hands according to specific frequencies of application.
Cryotherapy is more and more used to improve skin appearance. Devices using difluoroethane, manufactured by CRYONOVE PHARMA, are already available on the local and international markets, e.g. CRYOBEAUTY MAINS and CRYOBEAUTY CORPS. 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, it seems interesting for the sponsor to select other sequences of a cryogenic spray (4 prototypes of devices) which could be used for lentigo treatment with a same benefit for the consumers without any safety outcomes. This study will assess the use of different prototypes with a sequence of application of cryogenic gas which reaches a higher temperature than those which used with the reference device, in order to increase the acceptability of the device. (CS4_3) proof of concept, interventional, monocentric, aims to evaluate the tolerance of cryotherapy treatments applied on healthy skin on the back of the hands. The main objective of the study is to evaluate on phototype V and VI, the tolerance of 4 different conditions of cryotherapy treatments (4 prototypes) applied on healthy skin on the back of the hands.
Solar lentigos or lentigines are harmless patch of darkened skin, of different sizes and colors, due to the exposure to UV radiation. They are very common, especially in people over the age of 40 years old. Solar lentigines appears as clusters of similar lesions on sun-exposed sites, such as the face or the back of the hands. Conventional cryotherapy is increasingly used to improve the skin appearance and especially to treat lentigo spots. However, the application of conventional cryotherapy is followed by temporary side effects including pain at application, hypo- and hyperpigmentation, crust, scars, burns, erythema... for a few days after administration and that can persist during several months. In this context, the sponsor has developed a treatment using cyto-selective cryotherapy, that treats only the melanocytes responsable of brown spots while preserving other cells of the epidermis. Several sequences of pulverization of cryogenic gas have been designed. It seems interesting for the sponsor to study some ways of applications of the selected sequences. i.e. 5 conditions evaluated) that could be used for the treatment of lentigos with the same clinical benefit and with better safety results for patients . (CS4_2) proof of concept, interventional, monocentric, randomized and double blinded study, aims to evaluate the tolerance and the mode of administration of cyto-selective difluoroethane-based cryotherapy in the treatment of brown spots. The main objective of the study is to evaluate the tolerance and to adjust the mode of administration of 3 different cryotherapy treatments (3 prototypes) applied on the brown spots of the face. Each treatment corresponds to a specific sequence of a cryogenic spray.
In this study, the investigators demonstrated that in vivo THG microscopy can differentiate Solar lentigos (SL), Nevus zygomaticus(NZ) and normal skin based on the optical nature of melanin. This THG-based procedure provides a valuable tool for noninvasive determination of third-order nonlinear susceptibility of melanin within the skin. It can also provide real-time histopathology information for treatment follow-up, without performing an invasive skin biopsy.