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Tolerance of Cyto-selective Difluoroethane-based Cryotherapy in the Treatment of Post-inflamamatory Hyperpigmentation (PIH).

NCT05495503 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-06-26

No results posted yet for this study

Summary

CS5\_2 study aims to evaluate the tolerance of 4 different conditions of cryotherapy treatments applied on dorsal post-inflammatory hyperpigmentation (PIH) spots.

This study is a proof of concept, designed to be interventional, monocentric, randomized and double blind.

The study will evaluate 4 prototypes : (814A-v1), (814B-v1), (814C-v1) and (814D-v1).

Conditions

  • Post-inflammatory Hyperpigmentation

Interventions

DEVICE

Prototype (814A-v1)

Application on PIH located on the dorsal area (2 treatments during the study).

DEVICE

Prototype (814B-v1)

Application on PIH located on the dorsal area (2 treatments during the study).

DEVICE

Prototype (814C-v1)

Application on PIH located on the dorsal area (2 treatments during the study).

DEVICE

Prototype (814D-v1)

Application on PIH located on the dorsal area (2 treatments during the study).

Sponsors & Collaborators

  • Dermatech

    collaborator INDUSTRY

  • CEISO

    collaborator INDUSTRY

  • Cryonove Pharma

    lead INDUSTRY

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2022-10-18
Primary Completion
2022-12-14
Completion
2022-12-14

Countries

  • South Africa

Study Locations

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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 NCT05495503 on ClinicalTrials.gov