Evaluation of the Tolerance and Performance (Mode of Administration) of Cyto-selective Difluoroethane-based Cryotherapy in the Treatment of Brown Spots
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cryonove Pharma
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Change from baseline skin hyperpigmentation
Study Overview
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)
Detailed Description
Rational:
Solar lentigo is a harmless patch of darkened skin. It results from exposure to ultraviolet (UV) radiation, which causes local proliferation of melanocytes and accumulation of melanin within the skin cells (keratinocytes). Solar lentigos or lentigines are very common, especially in people over the age of 40 years. Solar lentigines are found on sun-exposed sites, particularly the face or the back of hands.
Cryotherapy is more and more used to improve skin appearance and currently used to treat lentigo spot. However, the cryogenic gas (conventional cryotherapy - liquid nitrogen) creates a dermabrasion of the skin surface and person receiving this kind of treatment presents an impaired skin during a few days following the treatment as temporary damage of stratum corneum, erythema, scars, burns.
Following the side effects occurring after conventional cryotherapy application, the Sponsor has developed some devices using difluoroethane, manufactured by CRYONOVE PHARMA, already available on the local and international markets, e.g. CRYOBEAUTY MAINS and CRYOBEAUTY CORPS.
To continue it research and development activities, it seems interesting for the sponsor to select other sequences of a cryogenic spray which could be used for lentigo treatment with a same benefit for the consumers without any safety outcomes.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 30 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Female or male.
- •Ages 30 to
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Condition 1 : prototypes from (815-v1 001) to (815-v1 050) every day
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.
Intervention: Prototypes (815-v1 001) to (815-v1 050) (Device)
Condition 2 : prototypes from (815-v1 051) to (815-v1 100) every week
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.
Intervention: Prototype (815-v1 051) to (815-v1 100) (Device)
Conditions 3 : prototypes from (815-v1 101) to (815-v1 150) every two weeks
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.
Intervention: Prototypes (815-v1 101) to (815-v1 150) (Device)
Condition 4 : prototypes from (815-v1 151) to (815-v1 200) every two weeks
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.
Intervention: Prototypes (815-v1 151) to (815-v1 200) (Device)
Outcomes
Primary Outcomes
Change from baseline skin hyperpigmentation
Time Frame: 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
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).
Change from baseline skin appearance
Time Frame: 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
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.
Self-assesment of pain by VAS
Time Frame: Day 0
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."
Change from baseline skin hypopigmentation
Time Frame: 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
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.
Change from baseline skin sensation
Time Frame: 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
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.
Change from baseline spots visibility
Time Frame: 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
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).
Secondary Outcomes
- 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)