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

NCT05600049 | Completed

• 1 other identifier: CS5_1
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

CS5\_1 study aim 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 hand with 3 prototypes. 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 : from (815-v1 001) to (815-v1 100)
• Prototype 2 : from (815-v1 101) to (815-v1 150)
• Prototype 3 : from (815-v1 151) to (815-v1 200)

Conditions

Lentigo Solar

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 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 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 lentigo (and spotless surrounding each spot in the same acquisition) and a spotless area (one on face (same as clinical evaluation) and far from a lentigo spot).

  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

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 (4)

Condition 1 : prototypes from (815-v1 001) to (815-v1 050) every day

EXPERIMENTAL

Application on the brown spots of the face and/or hands for the prototypes (815-v1 001) to (815-v1 050) at D0, D1, D2, D3, D4 and D5.

Device: Prototypes (815-v1 001) to (815-v1 050)

Condition 2 : prototypes from (815-v1 051) to (815-v1 100) every week

EXPERIMENTAL

Application on the brown spots of the face and/or hands for the prototypes (815-v1 051) to (815-v1 100) at D0, D7, D14, D21, D28 and D35.

Device: Prototype (815-v1 051) to (815-v1 100)

Conditions 3 : prototypes from (815-v1 101) to (815-v1 150) every two weeks

EXPERIMENTAL

Application on the brown spots of the face and/or hands for the prototypes (815-v1 101) to (815-v1 150) at D0, D14, D28, D42, D56 and D70.

Device: Prototypes (815-v1 101) to (815-v1 150)

Condition 4 : prototypes from (815-v1 151) to (815-v1 200) every two weeks

EXPERIMENTAL

Application on the brown spots of the face and/or hands for the prototypes (815-v1 151) to (815-v1 200) at D0, D14, D28, D42, D56 and D70.

Device: Prototypes (815-v1 151) to (815-v1 200)

Interventions

Prototypes (815-v1 001) to (815-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 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 from (815-v1 001) to (815-v1 050) every day

Prototype (815-v1 051) to (815-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 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 from (815-v1 051) to (815-v1 100) every week

Prototypes (815-v1 101) to (815-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 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.

Conditions 3 : prototypes from (815-v1 101) to (815-v1 150) every two weeks

Prototypes (815-v1 151) to (815-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 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 from (815-v1 151) to (815-v1 200) every two weeks

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female or male.
• Ages 30 to 75.
• Phototypes I to IV (according with Fitzpatrick scale).
• Featuring brown spots (solar lentigos, senile lentigo) on the face and hands ≥ 3 and ≤ 6 mm in diameter (at least 4 spots per subject for phototypes II and III and no specific requirements re accurate number of spots for phototypes I and IV).).
• 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, at the level of the face and the hands.
• Having applied a depraving product in the month prior to the start of the study, at the level of the face and the hands.
• Having performed cosmetic treatments in a dermatologist (laser, Intense Pulsed Light (IPL) , peeling, creams, cryotherapy ...), at the level of the face and the 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.
• 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 Georgian 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
• LTD HEALTH: collaborator

Study Sites (1)

Ltd "Health"

Batumi, Georgia

Location

MeSH Terms

Conditions

Hyperpigmentation; Skin Diseases

Condition Hierarchy (Ancestors)

Pigmentation Disorders; Skin and Connective Tissue Diseases

Study Officials

• Lela BERIDZE

  LTD HEALTH

  PRINCIPAL INVESTIGATOR

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: October 31, 2022
• Study Start: October 21, 2022
• Primary Completion: June 8, 2023
• Study Completion: June 8, 2023
• Last Updated: June 15, 2023

Record last verified: 2023-06

Locations

GE (1)