MedTrace Logo

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

NCT05883657 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-06-01

No results posted yet for this study

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)

Conditions

  • Solar Lentigo
  • Senile Lentigo
  • Post Inflammatory Hyperpigmentation

Interventions

DEVICE

Condition 1 : Prototypes (816-v1) every weeks

Application on brown spots located on the face and/or the hand (12 treatments during the study). An operator previously trained by the dermatologist will apply the study device to the patient's face or/and hand. Subjects will be lying down, and the prototypes will be administered upside down for the applications on the face and sitting for the applications on the hands. For the application on the hands, the hands will be placed flat on the table and the prototypes will be applied upside down. During applications on the face, subjects will wear diving goggles protecting the eyes from cryogenic gas.

DEVICE

Condition 2 : Prototypes (816-v1) every two weeks

Application on brown spots located on the face and/or the hand (6 treatments during the study). An operator previously trained by the dermatologist will apply the study device to the patient's face or/and hand. Subjects will be lying down, and the prototypes will be administered upside down for the applications on the face and sitting for the applications on the hands. For the application on the hands, the hands will be placed flat on the table and the prototypes will be applied upside down. During applications on the face, subjects will wear diving goggles protecting the eyes from cryogenic gas.

Sponsors & Collaborators

  • Dermatech

    collaborator INDUSTRY

  • CEISO

    collaborator INDUSTRY

  • Sefako Makgatho Health Sciences University

    collaborator OTHER

  • Cryonove Pharma

    lead INDUSTRY

Principal Investigators

  • Beverley Summers, Pr · Photobiology Laboratory

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-10
Primary Completion
2023-12-12
Completion
2023-12-12

Countries

  • South Africa

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05883657 on ClinicalTrials.gov