Performance and Tolerance of Cyto-selective Difluoroethane-based Cryotherapy in th Treatment of Brown Spots (Solar and Senile Lentigines, Post-Inflammatory Hyperpigmentation) on the Face and Hands of Asian Ethnicity Skins

NCT05886010 | Unknown

• 1 other identifier: CS5_4
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

CS5\_4 study aim to evaluate the performance and the tolerance of 3 prototypes of cyto-selective cryotherapy treatments applied on the brown spots on the face and hands of asian ethnicity skins (chinese). A brown spot is defined as solar or senile lentigo (SSL) and post-inflammatory hyperpigmentation (PIH). Each treatment corresponds to a combination of a specific sequence of cryogenic spray and of a frequency of application. Each spot will be treated by a defined prototype (always the same device on the same spot all along the study). The study will evaluate the following prototype :

• Prototypes 1
• Prototypes 2
• Prototypes 3

Conditions

Solar Lentigo; Senile Lentigo

Keywords

Cryotherapy; Hyperpigmentation; Skin Diseases

Outcome Measures

Primary Outcomes (6)

• Change from baseline skin hyperpigmentation

  The evaluation will be performed visually on the selected spots. A scale in 6 points (0 to 5) will be used : 0=Clear of hyperpigmentation; 1. Almost clear of hyperpigmentation; 2. mild, but noticeable hyperpigmentation; 3. moderate hyperpigmentation (medium brown in quality); 4. severe hyperpigmentation (dark brown in quality); 5. very severe hyperpigmentation (very dark brown, almost black in quality).

  Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 63, Day 70, Day 77, Day 91, Day 0 + 6 months

• Change from baseline skin hypopigmentation

  The evaluation will be performed visually on the selected spots. A scale in 5 points will be used (0 to 4): 0=no hypopigmented lesion; 1. very slight area of hypopigmentation of very small size and very slightly fairer than the surrounding skin; 2. slight area of hypopigmentation of small size and slightly fairer than the surrounding skin; 3. moderate : area of hypopigmentation of moderate size and much fairer than the surrounding skin; 4. severe : area of hypopigmentation of large size and much fairer than the surrounding skin.

  Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 63, Day 70, Day 77, Day 91, Day 0 + 6 months

• Change from baseline skin appearance - expected events

  The evaluation will be performed visually on the selected spots and surrounded spotless skin area around the spot skin to assess erythema, oedema blister, bubble, scars, micro-bruise, hematoma, dryness,desquamation, fissures/cracks, roughness,crust, pink spots and papules. A scale in 5 points (0 to 4) will be used : 0=none; 1. very mild; 2. mild; 3. moderate; 4. severe.

  Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 63, Day 70, Day 77, Day 91, Day 0 + 6 months

• Change from baseline skin sensation

  The evaluation will be performed visually on the selected spots and around the spot skin to assess tightness, stinging, itching, warm and burning sensation. A scale in 5 points (0 to 4) will be used : 0=none; 1. very mild; 2. mild; 3. moderate; 4. severe.

  Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 63, Day 70, Day 77, Day 91, Day 0 + 6 months

• Self-assesment of pain by VAS

  The pain of the treatment will be assessed by the Visual Analogue Scale (VAS) at time T0 on the treated area. The pain assessed is that felt during the application of the devices. It will be collected from the patient within 5 minutes of application. The VAS is made up of a 10-centimeter line anchored by two ends of the pain. 10 is the first end being the "maximum pain imaginable" and 0 is the other end being "no pain".

  Day 0

• Change from baseline spots visibility

  Standardized photographs will be taken using a Dermatoscope C-Cube® (PIXIENCE) which allows realizing high resolution skin pictures. The capture will be taken on the previously selected lentigo and a spotless area.

  Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 63, Day 70, Day 77, Day 91, Day 0 + 6 months

Study Arms (5)

Condition 1 :prototypes 1 everyday

EXPERIMENTAL

Application on the brown spots of the face and the hands for the prototypes 1 at D0,D1,D2,D3,D4 and D5

Device: prototypes 1 everyday

Condition 2 : prototypes 1 every week

EXPERIMENTAL

Application on the brown spots of the face and the hands for the prototypes 1 at D0,D7,D14,D21,D28, D35, D42, D49, D56, D63, D70 and D77.

Device: prototypes 1 every week

Condition 3 : prototypes 1 every two weeks

EXPERIMENTAL

Application on the brown spots of the face and the hands for the prototypes 1 at D0,D14,D28, D42, D56 and D70

Device: prototypes 1 every two weeks

Condition 4 : prototypes 2 every two weeks

EXPERIMENTAL

Application on the brown spots of the face and the hands for the prototypes 2 at D0,D14,D28, D42, D56 and D70

Device: prototypes 2 every two weeks

Condition 5 : prototypes 3 every two weeks

EXPERIMENTAL

Application on the brown spots of the face and the hands for the prototypes 3 at D0,D14,D28, D42, D56 and D70

Device: prototypes 3 every two weeks

Interventions

prototypes 1 everyday DEVICE

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.

Condition 1 :prototypes 1 everyday

prototypes 1 every week DEVICE

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.

Condition 2 : prototypes 1 every week

prototypes 1 every two weeks DEVICE

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.

Condition 3 : prototypes 1 every two weeks

prototypes 2 every two weeks DEVICE

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.

Condition 4 : prototypes 2 every two weeks

prototypes 3 every two weeks DEVICE

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.

Condition 5 : prototypes 3 every two weeks

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female or male,
• Chinese ethnicity skins,
• Ages between 18 years old and 75 years old,
• Phototype II or III (according to Fitzpatrick scale),
• Featuring brown spots ≥ 3 and ≤ 6 mm in diameter
• Agreeing not to be exposed to the sun (or artificial UV) during the study.
• Informed, having undergone a general clinical examination attesting to his/her ability to participate in the study.
• Having given written consent for their participation in the study.
• No suspicion of carcinoma after investigation by a dermatologist.

You may not qualify if:

• Having performed cosmetic treatments (exfoliants, scrubs or self-tanners, manicures, facials, UV ...) in the month before the start of the study where the prototypes will be applied.
• Having applied a depraving product in the month prior to the start of the study, where the prototypes will be applied.
• Having performed cosmetic treatments in a dermatologist (laser, Intense Pulsed Light (IPL), peeling, creams, cryotherapy ...) in the last 6 months where the prototypes will be applied (see restrictions paragraph).
• 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 ...) 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 the language of the documents involved in the study.
• Unable to be contacted urgently over the phone.
• For female subjects:
• Pregnant woman (or wishing to be pregnant during study) or while breastfeeding.
• A woman who does not have a contraceptive method.

Sponsors & Collaborators

• Cryonove Pharma: lead
• CEISO: collaborator

Study Sites (1)

Laboratoire BIO-EC

Longjumeau, 91160, France

Location

MeSH Terms

Conditions

Hyperpigmentation; Skin Diseases

Condition Hierarchy (Ancestors)

Pigmentation Disorders; Skin and Connective Tissue Diseases

Study Officials

• Michel Cadot

  Laboratoir BIO-EC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Léa SESTITO

CONTACT

0169414764; l.sestito@bio-ec.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: June 2, 2023
• Study Start: September 1, 2023
• Primary Completion: February 29, 2024
• Study Completion: February 29, 2024
• Last Updated: June 2, 2023

Record last verified: 2023-05

Locations

FR (1)