Tolerance of Cyto-selective Difluoroethane-based Cryotherapy in the Treatment of Post-inflamamatory Hyperpigmentation (PIH).

NCT05495503 | Completed

• 1 other identifier: CS5_2
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

CS5\_2 study aims to evaluate the tolerance of 4 different conditions of cryotherapy treatments applied on dorsal post-inflammatory hyperpigmentation (PIH) spots. This study is a proof of concept, designed to be interventional, monocentric, randomized and double blind. The study will evaluate 4 prototypes : (814A-v1), (814B-v1), (814C-v1) and (814D-v1).

Conditions

Post-inflammatory Hyperpigmentation

Keywords

Cryotherapy; Hyperpigmentation; Skin Diseases

Outcome Measures

Primary Outcomes (6)

• Change from baseline skin hyperpigmentation

  Clinical evaluation of outcomes on each selected and treated spot will be performed by a Dermatologist by scoring with standardized position and lighting at each visit and before each treatment. 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 and Day 56

• Change from baseline skin hypopigmentation

  Clinical evaluation of outcomes on each selected and treated spot will be performed by a Dermatologist by scoring with standardized position and lighting at each visit and before each treatment. 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 and Day 56

• Change from baseline skin appearance

  Clinical evaluation of outcomes on each selected and treated spot will be performed by a Dermatologist by scoring with standardized position and lighting at each visit and before each treatment. 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. 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 and Day 56

• Change from baseline skin sensation

  Clinical evaluation of outcomes on each selected and treated spot will be performed by a Dermatologist by scoring with standardized position and lighting at each visit and before each treatment. 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 and Day 56

• Self-assesment of pain

  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 spot (and spotless surrounding each spot in the same acquisition) and a spotless area (one on back and far from PIH spot). Acquisition will be performed at Day0/time 0 (before treatment) and at each visit.

  Day 0, Day 7, Day 14, Day 21, Day 28 and Day 56

Study Arms (4)

Prototype (814A-v1)

EXPERIMENTAL

Application of the prototype (814A-v1) at D0 and D7.

Device: Prototype (814A-v1)

Prototype (814B-v1)

EXPERIMENTAL

Application of the prototype (814B-v1) at D0 and D7.

Device: Prototype (814B-v1)

Prototype (814C-v1)

EXPERIMENTAL

Application of the prototype (814C-v1) at D0 and D7.

Device: Prototype (814C-v1)

Prototype (814D-v1)

EXPERIMENTAL

Application of the prototype (814D-v1) at D0 and D7.

Device: Prototype (814D-v1)

Interventions

Prototype (814A-v1) DEVICE

Application on PIH located on the dorsal area (2 treatments during the study).

Prototype (814A-v1)

Prototype (814B-v1) DEVICE

Application on PIH located on the dorsal area (2 treatments during the study).

Prototype (814B-v1)

Prototype (814C-v1) DEVICE

Application on PIH located on the dorsal area (2 treatments during the study).

Prototype (814C-v1)

Prototype (814D-v1) DEVICE

Application on PIH located on the dorsal area (2 treatments during the study).

Prototype (814D-v1)

Eligibility Criteria

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

You may qualify if:

• Female or male.
• African ethnicity
• Ages 18 to 65.
• Phototype V and VI according to Fitzpatrick scale
• Featuring brown spots (PIH) on the back ≥ 3 mm to ≤ 6 mm in diameter (at least 4 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 ability to participate in the study.
• Having given written consent for 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, UV ...) in the month before the start of the study, at the level of the back.
• Having applied a depilatory or exfoliating product in the month prior to the start of the study, at the level of the back.
• Having performed cosmetic treatments in a dermatologist (laser, Intense Pulsed Light (IPL), peeling, creams, cryotherapy ...), at the level of the back 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, anti-coagulants ...) 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 English language.
• Unable to be contacted urgently over the phone.
• Been on any other medication which may affect the outcome of the study or affect the skin condition in some way.
• Having ever undergone chemotherapy or other radiation treatment or received any prescription medication or medical treatment understood by them to affect the skin condition.
• Having any skin condition otherwise unsuitable for treatment in the opinion of the Investigator or clinician.
• For female subjects:

Sponsors & Collaborators

• Cryonove Pharma: lead
• Dermatech: collaborator
• CEISO: 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

  beverley.summers@smu.ac.za

  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: August 4, 2022
• First Posted: August 10, 2022
• Study Start: October 18, 2022
• Primary Completion: December 14, 2022
• Study Completion: December 14, 2022
• Last Updated: June 26, 2023

Record last verified: 2023-06

Locations

ZA (1)