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

NCT05883657 | Unknown

• 1 other identifier: CS5_7
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cryotherapy; Skin Disease; Hyperpigmentation

Outcome Measures

Primary Outcomes (7)

• 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 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 63, Day 70, Day 77, Day 84 and 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 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 63, Day 70, Day 77, Day 84 and Day 0 + 6 months

• Change from baseline skin appearance

  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 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 63, Day 70, Day 77, Day 84 and 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 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 63, Day 70, Day 77, Day 84 and 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 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 63, Day 70, Day 77, Day 84 and Day 0 + 6 months

• Incidence of unexpected events

  Unexpected events

  Day 0, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 63, Day 70, Day 77, Day 84 and Day 0 + 6 months

Secondary Outcomes (1)

• Self assessment of skin appearance

  Day 0, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 70, Day 84 and Day 0 + 6 months

Study Arms (2)

Condition 1 : Prototypes (816-v1) every weeks

EXPERIMENTAL

Application on the brown spots of the face and the hands for the prototypes (816-v1) at D0, D7, D14, D21, D28, D35, D42, D49, D56, D63, D70 and D77.

Device: Condition 1 : Prototypes (816-v1) every weeks

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

EXPERIMENTAL

Application on the brown spots of the face and the hands for the prototypes (816-v1) at D0, D14, D28, D42, D56 and D70.

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

Interventions

Condition 1 : Prototypes (816-v1) every weeks 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 1 : Prototypes (816-v1) every weeks

Condition 2 : Prototypes (816-v1) 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 2 : Prototypes (816-v1) 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.
• Ages 18 to 75.
• Phototypes V and VI (according with Fitzpatrick scale), according to the spots' distribution table.
• Featuring brown spots ≥ 3 and ≤ 6 mm in diameter (on the face (and when possible, on the hands).
• 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 (only nails care acceptable), facials, UV ...) in the month before the start of the study, at the level of the face and/or hands.
• Having applied a depilatoring product in the month prior to the start of the study, on the face and/or hands.
• Having performed cosmetic treatments in a dermatologist (laser, Intense Pulsed Light (IPL), peeling, creams, cryotherapy ...), on the face and/or hands 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 ...) likely to interfere with the evaluation of the parameter studied.
• 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.
• 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
• Dermatech: collaborator
• CEISO: collaborator
• Sefako Makgatho Health Sciences University: collaborator

Study Sites (1)

Photobiology Laboratory, Sefako Makgatho Health Sciences University

Pretoria, Gauteng, 0204, South Africa

Location

MeSH Terms

Conditions

Hyperpigmentation; Skin Diseases

Condition Hierarchy (Ancestors)

Pigmentation Disorders; Skin and Connective Tissue Diseases

Study Officials

• Beverley Summers, Pr

  Photobiology Laboratory

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Christophe ANTON

CONTACT

+33 6 80 23 61 13; jc.anton@cryonovepharma.com

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 22, 2023
• First Posted: June 1, 2023
• Study Start: June 10, 2023
• Primary Completion: December 12, 2023
• Study Completion: December 12, 2023
• Last Updated: June 1, 2023

Record last verified: 2023-04

Locations

ZA (1)