Tolerance and Mode of Administration of Cyto-selective Cryotherapy Treatments in Face Brown Spots: Proof of Concept
Condition: Solar Lentigo
MeSH terms: Lentigo
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      Prototypes (810A-v1), (810B-v1) and (810C-v1) will be applied on brown spots located on the
      face. Regarding the randomization list, each spot will be treated by a defined prototype /
      device (same prototype /device will be used to treat the same spot all along the study).

      Each spot will be treated 6 times during the study:

        -  At Day 0, Day 1, Day 2, Day 3 Day 4 and Day 5 for the prototypes (810A-v1) (condition 1)
           and (810B-v1) (condition 2).

        -  At Day 0, Day 7, Day 14, Day 21, Day 28 and Day 35 for the prototypes (810A-v1)
           (condition 3) and (810C-v1) (condition 4).

        -  At Day 0, Day 14, Day 28, Day 42, Day 56 and Day 70 for the prototype (810C-v1)
           (condition 5, considered as reference).

      Prior to any study device application, the dermatologist will assess the adverse events and
      decide whether the period between two consecutive applications should be extended or not. The
      dermatologist will verify that the skin has not been treated with cosmetic products (no
      cream, peeling, dermabrasion, laser treatment... that could interfere with the treatment) and
      that is dry.

      The procedure will take place at the investigation site. An operator previously trained by
      the dermatologist will apply the study device to the patient's brown spots.

      Subjects will lie down and the device will be administered upside down. During the
      applications, subjects will wear diving goggles (provided by the CRO) to protect the eyes
      from the cryogenic gas.

      Treatments will be stopped when a total of 6 applications for the prototypes will be
      delivered or as soon as a spot will be considered disappeared by the investigator. Otherwise
      the study will continue (tolerance report, etc.) until all conditions are completed.
    

Intervention name(s): (810A-v1) device prototype; (810B-v1) device prototype; (810C-v1) device prototype
Intervention type(s): Device; Device; Device
Intervention description(s): Sequence with Serial Number from (810-v1 101) to (810-v1 140). Application on brown spots located on the face (6 treatments during the study).; Sequence with Serial Number (810-v1 141) to (810-v1 160). Application on brown spots located on the face (6 treatments during the study).; Sequence with Serial Number (810-v1 161) to (810-v1 200). Application on brown spots located on the face (6 treatments during the study).
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lentigo; Melanosis; melanocyte; melanosome; Hyperpigmentation; Pigmentation Disorders; Skin Diseases