Tolerance and Performance of Cyto-selective Difluoroethane-based Cryotherapy in the Treatment of Brown Spots.

NCT05625815 | Completed

• 1 other identifier: CS5_3
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

CS5\_3 aims to evaluate the tolerance and to adjust the mode of administration of 4 different conditions of cryotherapy treatments applied on the brown spots of the face and hands with 3 prototypes. A brown spot is defined as solar or senile lentigo and post-inflammatory hyperpigmentation (PIH). Each treatment corresponds to a combination of a specific sequence of a cryogenic spray and of a frequency of application. The study will evaluate 3 prototypes :

• Prototype 1 : SN from (816-v1 001) to (816-v1 100)
• Prototype 2 : SN from (816-v1 101) to (816-v1 150)
• Prototype 3 : SN from (816-v1 151) to (816-v1 200) Prototypes will be applied on the face and hands according to specific frequencies of application.

Conditions

Solar Lentigo; Senile Lentigo; Post-inflammatory 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 70,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 70,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 70,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 70,Day 84 and Day 0 + 6 months

• Self-assesment of pain by the 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. One end is the "maximum pain imaginable". The other end is "no pain."

  Day 0

• Change from baseline spots visibility

  Standardized photographs will be taken using a Dermatoscope C-Cube® (PIXIENCE).The capture will be taken on the previously selected PIH/lentigo and a spotless area

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

• Rating of spots and spotless areas visibility

  Evaluation will be performed using a lentigines global improvement scale. Scoring of spots and spotless areas will be performed after the end of D84 visits on C-cube images by 3 dermatologists. It will be performed for each condition on pictures taken 2 weeks after the end of the treatment for the concerned condition.

  Day 21, Day 49, Day 84

Secondary Outcomes (1)

• Self assessment of skin appearance

  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 (4)

Condition 1: prototypes from (816-v1 001) to (816-v1 050) every day

EXPERIMENTAL

Application on the brown spots of the face and/or hands for the prototypes (816-v1001) to (816-v1 050) at D0, D1, D2, D3, D4 and D5.

Device: Prototypes (816-v1 001) to (816-v1 050)

Condition 2: prototypes from (816-v1 051) to (816-v1 100) every week

EXPERIMENTAL

Application on the brown spots of the face and/or hands for the prototypes (816-v1 051) to (816-v1 100) at D0, D7, D14, D21, D28 and D35.

Device: Prototype (816-v1 051) to (816-v1 100)

Conditions 3 : prototypes from (816-v1 101) to (816-v1 150) every two weeks

EXPERIMENTAL

Application on the brown spots of the face and/or hands for the prototypes (816-v1 101) to (816-v1 150) at D0, D14, D28, D42, D56 and D70.

Device: Prototypes (816-v1 101) to (816-v1 150)

Condition 4 : prototypes from (816-v1 151) to (816-v1 200) every two weeks

EXPERIMENTAL

Application on the brown spots of the face and/or hands for the prototypes (816-v1 151) to (816-v1 200) at D0, D14, D28, D42, D56 and D70.

Device: Prototypes (816-v1 151) to (816-v1 200)

Interventions

Prototypes (816-v1 001) to (816-v1 050) 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 supine, 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 from (816-v1 001) to (816-v1 050) every day

Prototype (816-v1 051) to (816-v1 100) 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 supine, 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 from (816-v1 051) to (816-v1 100) every week

Prototypes (816-v1 101) to (816-v1 150) 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 supine, 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.

Conditions 3 : prototypes from (816-v1 101) to (816-v1 150) every two weeks

Prototypes (816-v1 151) to (816-v1 200) 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 supine, 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 from (816-v1 151) to (816-v1 200) 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 if 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, on the face and/or hands.
• Having applied a depilatory 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 pulse light, 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
• CEISO: collaborator
• Dermatech: collaborator
• Sefako Makgatho Health Sciences University: collaborator

Study Sites (1)

SMU - Photobiology Laboratory, Sefako Makgatho Health Sciences University

Pretoria, South Africa

Location

MeSH Terms

Conditions

Hyperpigmentation

Condition Hierarchy (Ancestors)

Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

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: October 26, 2022
• First Posted: November 23, 2022
• Study Start: April 17, 2023
• Primary Completion: August 7, 2023
• Study Completion: October 10, 2023
• Last Updated: January 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)