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Solar Lentigo clinical trials

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NCT ID: NCT05625815 Completed - Solar Lentigo Clinical Trials

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

Start date: April 17, 2023
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05322668 Completed - Solar Lentigo Clinical Trials

Tolerance of Cyto-selective Difluoroethane-based Cryotherapy

AGILE3
Start date: January 17, 2022
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05203263 Completed - Solar Lentigo Clinical Trials

Tolerance and Mode of Administration of Cyto-selective Cryotherapy Treatments in Face Brown Spots: Proof of Concept

AGILE2
Start date: December 15, 2021
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT03225729 Completed - Solar Lentigo Clinical Trials

Assessment of CRYOBEAUTY MAINS ET DECOLLETE Versus Liquid Nitrogen Cryotherapy, in the Treatment of Solar Lentigines

CBT-EC2
Start date: October 25, 2017
Phase: N/A
Study type: Interventional

This study evaluates the performance of new technology "CRYOTHERAPY MAINS ET DECOLLETE" against a classic cryotherapy "Nitrogen Liquid " to treat solar lentigines. The hands and the neckline will be randomised, either left or right side and treated by two cryotherapy devices: 1. CRYOTHERAPY MAINS ET DECOLLETE is the device under evaluation. 2. Liquid nitrogen is a comparator device.

NCT ID: NCT03157427 Completed - Solar Lentigo Clinical Trials

Clinical Evaluation of the Performance of a Difluoroethane-based Cyto-selective Cryotherapy to Treat Dark Spots on the Hand in 30 Volunteers.

CBT
Start date: June 21, 2017
Phase: N/A
Study type: Interventional

This study evaluates the performance of "CRYOBEAUTY MAINS", a Cyto-selective Cryotherapy based on Difluoroethane as a treatment of Solar Lentigines in 30 volunteers. Only one application of "CRYOBEAUTY MAINS" in one hand (right or left hand according to the randomization code).