An interventional study of EC16 medical device (CE marked) and device prototype (810A-v1) in Lentigo Solar, sponsored by Cryonove Pharma. Completed at 1 site in Ukraine. Open to participants aged 30 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-30.
Sponsored by Cryonove Pharma · Not applicable, Interventional, and Treatment
CRYO (N° 21D588A0001) study aims to evaluate the tolerance and adjust the mode of administration of a cyto-selective difluoroethane-based cryotherapy in the treatment of brown spots.
The study is a proof of concept on a small panel of subjects and has been designed to be interventional, monocentric, randomized and double blind.
The study will include three device prototypes and a CE marked device (trademark URGO CRYOBEAUTY MAINS-BRAS-JAMBES) used as reference.
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.
CRYONOVE PHARMA develops and manufactures cryotherapy-based devices to improve skin appearance and treat lentigo spot. The mode of action of CRYONOVE devices consists to "provoke a selective cell death (melanocyte \& melanosome) by thermic shock induced by a rapid decrease in skin temperature via the diffusion of difluoroethane gas to the skin".
In this proof of concept study, the sponsor aims to assess the tolerance and the admininistration mode of cryogenic spray which could be used for lentigo treatment on the face.
The study is exploratory, interventional, monocentric, randomized and double blind.
Three prototypes of devices for face are compared to a CE marking device (trademark URGO CRYOBEAUTY MAINS-BRAS-JAMBES) used as reference.
Twelve subjects with at least 4 spots on face are expected to be included, in order to evaluate a minimum of 48 brown spots. Volunteers are treated at T0 only with the reference device and at T0, T2, T4, T6 weeks with the prototype devices. The patient follow-up include 10 visits from D0 to D56.
28 studies on the registry are indexed under Lentigo; 2 are open to participants now.
This study's enrollment of 12 is below the median of 30 across 25 interventional studies indexed under Lentigo.
Browse Lentigo studies →Cryonove Pharma is the lead sponsor of 11 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
For female subjects:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Application on brown spots located on the face (1 treatment during the study).
Also known as: CNV Body
Application on brown spots located on the face (4 treatments during the study).
Application on brown spots located on the face (4 treatments during the study).
Application on brown spots located on the face (4 treatments during the study).
TOLERABILITY : Post-treatment pain assessement
The pain of the treatment will be assessed by the VAS (Visual Analogue Scale). Pain intensity is measured in millimeters by the distance from the position of the mark to the "no pain" extremity. Based on the distribution of pain VAS scores in postoperative patients, the following bounds were recommended for the assessment of this scale: no pain (0-4mm), mild pain (5-44mm), moderate pain (45-74 mm) and severe pain (75- 100 mm). The expected outcomes are pain score \< 44 mm (mild pain) for CNV Body and score \< 4 mm (no pain) for each prototype.
Time frame: Day 0 (Time1 defined as 15 minutes post-treatment)
TOLERABILITY : Appearance of edemas, blisters, bubbles or scars.
Clinical evaluation of treated lentigo spot will be performed by a Dermatologist by scoring with standardized position and lighting. The evaluation will be performed visualy on the selected lentigo spots and surrounded spotless skin area around the spot skin. A scale in 5 points (0 to 4) will be used : 0=none; 1=very mild; 2=mild; 3=moderate; 4=severe. The expected score is \< 1.
Time frame: Day 56
PERFORMANCE : Skin color evaluation
Clinical evaluation of each treated lentigo spot and spotless area (one on face and far from a lentigo spot) will be performed in blinded conditions by a trained assessor by scoring using L'OREAL ColorChart\* in standardized position and lighting. The score delta between Day 56 post treatment and D0 pre-treatment will be calculated. The expected results is a score delta (D56-D0) \< -1 for lighteness of lentigo spot. \*Jean de Rigal, Marie-Laurence Abella, Franck Giron, Laurence Caisey, Marc André Lefebvre - Development and validation of a new Skin Color Chart® - Skin Research1 Technology, January 2007.
Time frame: Day 56
TOLERABILITY : Hyperpigmentation
Clinical evaluation of hyperpigmentation on each selected and treated lentigo spot will be performed by a Dermatologist by scoring with standardized position and lighting. The evaluation will be performed visualy on the selected lentigo 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). The expected outcomes are Score ≤ 3 (moderate hyperpigmentation, medium brown in quality) for CNV Body and Score ≤ 2 (mild, but noticeable hyperpigmentation) for each prototype.
Time frame: Day 0/Time 0 to Day 56
TOLERABILITY : Hypopigmentation
Clinical evaluation of hyperpigmentation on each selected and treated lentigo spot will be performed by a Dermatologist by scoring with standardized position and lighting. The evaluation will be performed visualy on the selected lentigo spots. A scale in 5 points (0 to 4) will be used: 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. The expected outcomes are Score ≤ 3 (area of hypopigmentation of moderate size and much fairer than the surrounding skin) for the CNV body device and Score ≤ 2 (slight area of hypopigmentation of small size and slightly fairer than the surrounding skin) for each prototype.
Time frame: Day 0/Time 0 to Day 56
TOLERABILITY : Erythema
Clinical evaluation of treated lentigo spot will be performed by a Dermatologist by scoring with standardized position and lighting. The evaluation will be performed visualy on the selected lentigo spots and surrounded spotless skin area around the spot skin. A scale in 5 points (0 to 4) will be used : 0=none; 1=very mild; 2=mild; 3=moderate; 4=severe. The expected score is ≤ 3 (moderate) for the CNV body device and score ≤ 2 (mild) for each prototype device.
Time frame: Day 0/Time 0 to Day 56
TOLERABILITY : Skin sensation
The dermatologist will collect functional signs by asking the subjects about tightness, stinging, itching, warm or burning sensation. The evaluation will be performed visualy regarding the selected lentigo spots and surrounded spotless skin area around the spot skin. A scale in 5 points (0 to 4) will be used : 0=none; 1=very mild; 2=mild; 3=moderate; 4=severe. The expected score is ≤ 3 (moderate) for the CNV body device and score ≤ 2 (mild) for each prototype device.
Time frame: Day 0/Time 0 to Day 56
PERFORMANCE: Standardized photographs by C-Cube® acquisition
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). Acquisition will be performed at Day0/time 0 (before treatment) and at each visit. The expected outcomes at day 56 are a score delta (D56-D0) \> 2,5 for ITA of lentigo spot for the CNV Body device and a score delta (D56-D0) \> 2 for ITA of lentigo spot for the prototype devices.
Time frame: Day 56
EFFICACY: Self-assessment of the subject
Data will be completed by a questionnaire elaborated by the sponsor and filled in by subjects. It allowed obtaining the subjective appraisal of subject on tested laser act using the following 5-point scale: agree; quite agree; neither agree, nor disagree; quite disagree; disagree. The items are the following: * The spot seems clearer. * The size of the spot seems reduced. * The spot seems less visible. The expected results are subject appraisal at day 42 "agree" on the 3 parameters a for the CNV Body device and "agree" or "quite agree" on the 3 parameters for the prototype devices.
Time frame: From Day 2 to Day 42
TOLERABILITY: other expected events
Clinical evaluation of treated lentigo spot will be performed by a Dermatologist regarding dryness, desquamation, fissures, cracks, roughness or crust. The evaluation will be done visualy by scoring on the selected lentigo spots and surrounded spotless skin area around the spot skin, with standardized position and lighting. A scale in 5 points (0 to 4) will be used : 0=none; 1=very mild; 2=mild; 3=moderate; 4=severe. The expected score is ≤ 3 (moderate) for the CNV body device and score ≤ 2 (mild) for each prototype device.
Time frame: Day 0/Time 0 to Day 56
Plan to share: No
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Ran from May 2021 to primary completion in May 2021, 0 months.
Of 11 interventional studies with no phase under Lentigo, half reached primary completion within 2 months of starting (the median); a quarter within 1 and three quarters within 13. This study's 0 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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