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

NCT ID: NCT05495503

Last Updated: 2023-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-18
• Study Completion Date: 2022-12-14

Brief 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).

Detailed Description

Background:

Hyperpigmentation is a problem in all skin types. Safe depigmentation is a challenge. Cryotherapy with liquid nitrogen at -70 °C has been used in the treatment of solar skin lesions for many years but causes considerable damage.

Difluoroethane sprays (CRYONOVE) induce skin temperatures from -5 to -15 °C which ablates melanocytes but leaves the other skin cells viable, causing less discomfort and damage. The prototype sprays in this proof of concept study have been proven safe and effective in the treatment of hyperpigmentation (solar lentigines) in Fitzpatrick skin types (FST) I to IV. Although lentigines are uncommon in darker phototypes, hyperpigmentation (PIH and melasma) is a major issue, thus this study seeks to assess the tolerance (acceptability) of the approach in hyperpigmented unexposed dorsal skin.

Following the side effects occurring after conventional cryotherapy application, the sponsor has selected other sequences of a specific cryogenic spray which has been used effectively and safely for lentigos treatment in Fitzpatrick Phototypes I to IV, with benefit for the consumers without any adverse safety outcomes. There is therefore a need to test the devices on darker skin types (Fitzpatrick V and VI), which also encounter hyperpigmentation challenges.

Design:

In this proof of concept study, the sponsor aims to evaluate the tolerance of 4 prototypes of cryogenic spray.

Intervention:

The prototypes are (814A-v1), (814B-v1), (814C-v1) and (814D-v1) and will be applied on PIH located on the dorsal area. Each treatment corresponds to a specific sequence of a cryogenic spray.

12 subjects will be includes to reach at least 48 brown spots treated. The PIH spots must be between ≥ 3 mm to ≤ 6 mm in diameter.

Each spot will be treated by one of a defined prototype (always the same prototype on the same spot all along the study) and will be treated twice during the study with a 15-day interval between each treatment. At D0, D14 for all the prototypes (814A-v1), (814B-v1), (814C-v1) and (814D-v1).

The follow up visits will be programmed at D7, D21, D28 and D56 for the end visit.

In total this study extends over 8 weeks and involves seven visits (D<0 (inclusion visit), D0,D7, D14, D21, D28 and D56).

Prior to any study device application, the dermatologist will assess the adverse events and will decide if the period between the two applications should be extended or not. The dermatologist will verify that the skin has not been treated by cosmetic products (no presence of cream that could interfere with the treatment) and is dry.

An operator previously trained by the dermatologist will apply the study device to the patient's spots.

Subjects will be lying on their abdomen to make application more stable, and the treatment will be administered with device.

Conditions

Post-inflammatory Hyperpigmentation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Prototype (814A-v1)

Application of the prototype (814A-v1) at D0 and D7.

Group Type: EXPERIMENTAL

Prototype (814A-v1)

Intervention Type: DEVICE

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

Prototype (814B-v1)

Application of the prototype (814B-v1) at D0 and D7.

Group Type: EXPERIMENTAL

Prototype (814B-v1)

Intervention Type: DEVICE

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

Prototype (814C-v1)

Application of the prototype (814C-v1) at D0 and D7.

Group Type: EXPERIMENTAL

Prototype (814C-v1)

Intervention Type: DEVICE

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

Prototype (814D-v1)

Application of the prototype (814D-v1) at D0 and D7.

Group Type: EXPERIMENTAL

Prototype (814D-v1)

Intervention Type: DEVICE

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

Interventions

Prototype (814A-v1)

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

Intervention Type: DEVICE

Prototype (814B-v1)

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

Intervention Type: DEVICE

Prototype (814C-v1)

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

Intervention Type: DEVICE

Prototype (814D-v1)

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Female or male.
• African ethnicity
• Ages 18 to 65.
• Phototype V and VI according to Fitzpatrick scale
• Featuring brown spots (PIH) on the back ≥ 3 mm to ≤ 6 mm in diameter (at least 4 spots per subject).
• Agreeing not to be exposed to the sun (or artificial UV) during the study.
• Informed, having undergone a general clinical examination attesting to his ability to participate in the study.
• Having given written consent for participation in the study.
• No suspicion of carcinoma after investigation by a Dermatologist.

Exclusion Criteria

• Having performed cosmetic treatments (exfoliants, scrubs or self-tanners, UV ...) in the month before the start of the study, at the level of the back.
• Having applied a depilatory or exfoliating product in the month prior to the start of the study, at the level of the back.
• Having performed cosmetic treatments in a dermatologist (laser, Intense Pulsed Light (IPL), peeling, creams, cryotherapy ...), at the level of the back in the last 6 months.
• With dermatosis, autoimmune disease, systemic, chronic or acute disease, or any other pathology that may interfere with treatment or influence the results of the study (people with diabetes or circulatory problems, allergic to cold, Raynaud's syndrome...).
• Receiving treatment by general or local (dermo corticoids, corticosteroids, diuretics, anti-coagulants ...) likely to interfere with the evaluation of the parameter studied.
• Participating in another study or being excluded from a previous study.
• Unable to follow the requirements of the protocol.
• Vulnerable: whose ability or freedom to give or refuse consent is limited.
• Major protected by law (tutorship, curatorship, safeguarding justice...).
• People unable to read and write English language.
• Unable to be contacted urgently over the phone.
• Been on any other medication which may affect the outcome of the study or affect the skin condition in some way.
• Having ever undergone chemotherapy or other radiation treatment or received any prescription medication or medical treatment understood by them to affect the skin condition.
• Having any skin condition otherwise unsuitable for treatment in the opinion of the Investigator or clinician.

For female subjects:

• Pregnant woman (or wishing to be pregnant during study) or while breastfeeding.
• A woman, who does not use effective methods of contraception.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dermatech

INDUSTRY

Sponsor Role: collaborator

CEISO

INDUSTRY

Sponsor Role: collaborator

Cryonove Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Beverley Summers

Role: PRINCIPAL_INVESTIGATOR

beverley.summers@smu.ac.za

Locations

Photobiology Laboratory, Sefako Makgatho Health Sciences University

Pretoria, Gauteng, South Africa

Countries

South Africa

Other Identifiers

CS5_2

Identifier Type: -

Identifier Source: org_study_id