Tolerance and Performance (Mode of Administration) of Cyto-selective Difluoroethane-based Cryotherapy in the Treatment of Brown Spots

NCT05793619 | Completed

• 1 other identifier: CS5_8
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

CS5\_8 study aim to evaluate the tolerance and to adjust the mode of administration of 2 different conditions of cryotherapy treatments applied on the brown spots of the face with 1 prototype (816-v1). Each treatment corresponds to a specific frequency of cryogenic spray application. The study will evaluate the following prototype : • Prototypes from (816-v1 301) to (816-v1 355)

Conditions

Lentigo Solar; Senile Lentigo

Keywords

cryotherapy; hyperpigmentation; Skin Diseases

Outcome Measures

Primary Outcomes (8)

• 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 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 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 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. 10 is the first end being the "maximum pain imaginable" and 0 is the other end being "no pain".

  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 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 70,Day 84 and Day 0 + 6 months

• Change from baseline spots color

  L'OREAL Color-Chart is a visual mode of evaluation chart which includes 4 items : * Color of lentigo spot * Lightness of lentigo spot * Color of spotless area * Lightness of spotless area The items color of lentigo spot and color of spotless area are using a scale redder to yellower in 7 points (G to M). The items lightness of lentigo spot and lightness of spotless are using a scale lighter to darker in 15 points (5 to 19)

  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 lentigines global improvement scale (LGIS) score

  Lentigines Global Improvement Scale (LGIS) score will be used to assess the spots visibility This is a 7-point scale : * Completely clear - 0 - : No evidence of hyperpigmentation 100% improvement * Almost clear - 1 - : Very significant clearance (about 90%); only minor evidence of hyperpigmentation remains * Marked improvement - 2 - : Significant improvement (about 75%); score evidence of hyperpigmentation remains * Moderate improvement - 3 - : intermediate between marked and slight improvement; about 50% improvement in the appearance of hyperpigmentation * Slight improvement - 4 - : some improvement (about 25%); however significant evidence of hyperpigmentation remains * No change - 5 - : Hyperpigmentation has not changed since baseline * Worse - 6 - : Worse (hyperpigmentation is worse that at baseline)

  Day 49 and Day 84

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 301) to (816-v1 355) every week

EXPERIMENTAL

Application on the brown spots of the face for the prototypes (816-v1 301) to (816-v1 355) at D0, D7, D14, D21, D28 and D35

Device: Prototypes (816-v1 301) to (816-v1 355) every week

Condition 2 : prototypes (816-v1 301) to (816-v1 355) every two weeks

EXPERIMENTAL

Application on the brown spots of the face for the prototypes (816-v1 301) to (816-v1 355) at D0, D14, D28, D42, D56 and D70

Device: Prototypes (816-v1 301) to (816-v1 355) every two weeks

Interventions

Prototypes (816-v1 301) to (816-v1 355) every week DEVICE

Application on brown spots located on the face (6 treatments during the study). An operator previously trained by the dermatologist will apply the study device to the patient's face. Subjects will be lying down, and the prototypes will be administered upside down. During applications, subjects will wear diving goggles protecting the eyes from cryogenic gas.

Condition 1 : prototypes (816-v1 301) to (816-v1 355) every week

Prototypes (816-v1 301) to (816-v1 355) every two weeks DEVICE

Application on brown spots located on the face (6 treatments during the study). An operator previously trained by the dermatologist will apply the study device to the patient's face. Subjects will be lying down, and the prototypes will be administered upside down. During applications, subjects will wear diving goggles protecting the eyes from cryogenic gas.

Condition 2 : prototypes (816-v1 301) to (816-v1 355) 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 ≥ 3 and ≤ 6 mm in diameter (at least 1 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/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, facials, UV ...) in the month before the start of the study, at the level of the face.
• Having applied a depraving product in the month prior to the start of the study, at the level of the face.
• Having performed cosmetic treatments in a dermatologist (laser, Intense Pulse Light, peeling, creams, cryotherapy ...), at the level of the face 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: March 20, 2023
• First Posted: March 31, 2023
• Study Start: April 4, 2023
• Primary Completion: October 26, 2023
• Study Completion: October 26, 2023
• Last Updated: November 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

GE (1)