Solar Lentigo Clinical Trial
Official title:
Evaluation of the Tolerance and Performance of Cyto-selective Difluoroethane-based Cryotherapy in the Treatment of Brown Spots (Solar and Senile Lentigines, Post-inflammatory Hyperpigmentation)
NCT number | NCT05625815 |
Other study ID # | CS5_3 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 17, 2023 |
Est. completion date | October 10, 2023 |
Verified date | January 2024 |
Source | Cryonove Pharma |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 32 |
Est. completion date | October 10, 2023 |
Est. primary completion date | August 7, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. - Participating in another study or being on a period of exclusion 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. For female subjects: - Pregnant woman (or wishing to be pregnant during study) or while breastfeeding. - A woman who does not have a contraceptive method. |
Country | Name | City | State |
---|---|---|---|
South Africa | SMU - Photobiology Laboratory, Sefako Makgatho Health Sciences University | Pretoria |
Lead Sponsor | Collaborator |
---|---|
Cryonove Pharma | CEISO, Dermatech, Sefako Makgatho Health Sciences University |
South Africa,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Self assessment of skin appearance | The skin appearance will be assessed by subjects through a 3 items questionnaire with 5-point scale | 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 |
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