Solar LentigoNCT05886010
Performance and Tolerance of Cyto-selective Difluoroethane-based Cryotherapy in th Treatment of Brown Spots (Solar and Senile Lentigines, Post-Inflammatory Hyperpigmentation) on the Face and Hands of Asian Ethnicity Skins
A study testing prototypes 1 everyday, prototypes 1 every week and prototypes 1 every two weeks in people with Solar Lentigo and Senile Lentigo, run by Cryonove Pharma at 1 site in France.
Trial summary
CS5_4 study aim to evaluate the performance and the tolerance of 3 prototypes of cyto-selective cryotherapy treatments applied on the brown spots on the face and hands of asian ethnicity skins (chinese). A brown spot is defined as solar or senile lentigo (SSL) and post-inflammatory hyperpigmentation (PIH). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solar Lentigo, Senile Lentigo
- What is being tested?
- prototypes 1 everyday, prototypes 1 every week and prototypes 1 every two weeks
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2023to 29 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female or male,
- Chinese ethnicity skins,
- Ages between 18 years old and 75 years old,
- Phototype II or III (according to Fitzpatrick scale),
- Featuring brown spots ≥ 3 and ≤ 6 mm in diameter
- Agreeing not to be exposed to the sun (or artificial UV) during the study.
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- 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.
Who cannot join
- Having performed cosmetic treatments (exfoliants, scrubs or self-tanners, manicures, facials, UV ...) in the month before the start of the study where the prototypes will be applied.
- Having applied a depraving product in the month prior to the start of the study, where the prototypes will be applied.
- Having performed cosmetic treatments in a dermatologist (laser, Intense Pulsed Light (IPL), peeling, creams, cryotherapy ...) in the last 6 months where the prototypes will be applied (see restrictions paragraph).
- 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.
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- 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 the language of the documents involved in the study.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Performance and Tolerance of Cyto-selective Difluoroethane-based Cryotherapy in th Treatment of Brown Spots (Solar and Senile Lentigines, Post-Inflammatory Hyperpigmentation) on the Face and Hands of Asian Ethnicity Skins
CS5_4 study aim to evaluate the performance and the tolerance of 3 prototypes of cyto-selective cryotherapy treatments applied on the brown spots on the face and hands of asian ethnicity skins (chinese). A brown spot is defined as solar or senile lentigo (SSL) and post-inflammatory hyperpigmentation (PIH).
Each treatment corresponds to a combination of a specific sequence of cryogenic spray and of a frequency of application. Each spot will be treated by a defined prototype (always the same device on the same spot all along the study).
The study will evaluate the following prototype :
- Prototypes 1
- Prototypes 2
- Prototypes 3
Read the detailed description
Rational :
Solar/senile lentigo (SSL) 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/senile lentigos or lentigines are very common, especially in people over the age of 40 years. Solar/senile lentigines are found as groups of similar lesions on sun-exposed sites, particularly the face or the back of hands.
Post-inflammatory hyperpigmentation (PIH) is an area of darker skin that remains after a pimple or wound heals. The discoloration is due to the production of excess melanin (pigment) as part of the skin's natural response to inflammation.
CRYONOVE is a medical device intended to induce a cyto-selective cryogenic action on melanocytes to remove brown spots resulting from solar or senile lentigines, post-inflammatory hyperpigmentation and melasma on the face and body.
Cryotherapy is more and more used to improve skin appearance and currently used to treat lentigo spot. Devices using difluoroethane, manufactured by CRYONOVE PHARMA, are already available on the local and international markets, e.g. CRYOBEAUTY MAINS and CRYOBEAUTY CORPS.
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, it seems interesting for the sponsor to select other sequences of a cryogenic spray (3 prototypes of devices for face and hands used according to different frequencies of application, i.e., 5 conditions evaluated) which could be used for lentigo and post inflammatory hyperpigmentation treatment in Asian Ethnicity Skin with a same benefit for the consumers without any safety outcomes.
Design:
The study performed is a proof of concept, exploratory, interventional, monocentric, randomized and single blinded
Intervention :
3 prototypes of devices are evaluated in 5 different conditions. Each treatment corresponds to a combination of a specific sequence of cryogenic spray and of a frequency of application.
For the conditions 1, 3, 4 and 5, each spot will be treated 6 times during the study :
- Every day from D0 and thus until D5 (condition 1);
- Every two weeks: at D0, D14, D28, D42, D56 and at D70 (condition 3):
- Every two weeks: at D0, D14, D28, D42, D56 and at D70 (condition 4);
- Every two weeks: at D0, D14, D28, D42, D56 and at D70 (condition 5).
For the condition 2, each spot will be treated 12 times during the study:
- Every week: at D0, D7, D14, D21, D28, D35, D42, D49, D56, D63, D70 and at D77 (condition 2);
120 participant will be included in the study. Overall, this study leads to treat 240 face spots (PIH, SSL) and 40 hands spots (SSL) with 3 prototypes having different temperature and kinetic.
Prior to any study device application, the dermatologist will assess the adverse events and will decide if the period between two consecutive applications should be extended or not.The dermatologist will verify that the skin has not been treated by cosmetic products (no presence of cream that could interfere with the treatment) and is dry.
An operator previously trained by the dermatologist will apply the study device to the patient's face or hands. Subjects will be lying down, and the device will be administered upside down. During applications on the face, subjects will wear diving goggles protecting the eyes from cryogenic gas. For the application on the hands, the hands will be placed flat on the table and the prototypes will be applied upside down.The treatment will be stoped after the disappearance of the spot.
The patient follow-up visits are from Day 0 to 6 months.
- Conditions
- Solar Lentigo, Senile Lentigo
- Being tested
- prototypes 1 everyday, prototypes 1 every week, prototypes 1 every two weeks, prototypes 2 every two weeks, prototypes 3 every two weeks
- Keywords
- Cryotherapy, Hyperpigmentation, Skin Diseases
- Medical subject headings
- Hyperpigmentation, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prototypes 1 everydayDevice
Application on brown spots located on the face and/or the hand (6 treatments during the study). An operator previously trained by the dermatologist will apply the study device to the patient's face or/and hand. Subjects will be lying down, and the prototypes will be administered upside down for the applications on the face and sitting for the applications on the hands. For the application on the hands, the hands will be placed flat on the table and the prototypes will be applied upside down. During applications on the face, subjects will wear diving goggles protecting the eyes from cryogenic gas.
prototypes 1 every weekDevice
Application on brown spots located on the face and/or the hand (12 treatments during the study). An operator previously trained by the dermatologist will apply the study device to the patient's face or/and hand. Subjects will be lying down, and the prototypes will be administered upside down for the applications on the face and sitting for the applications on the hands. For the application on the hands, the hands will be placed flat on the table and the prototypes will be applied upside down. During applications on the face, subjects will wear diving goggles protecting the eyes from cryogenic gas.
prototypes 1 every two weeksDevice
Application on brown spots located on the face and/or the hand (6 treatments during the study). An operator previously trained by the dermatologist will apply the study device to the patient's face or/and hand. Subjects will be lying down, and the prototypes will be administered upside down for the applications on the face and sitting for the applications on the hands. For the application on the hands, the hands will be placed flat on the table and the prototypes will be applied upside down. During applications on the face, subjects will wear diving goggles protecting the eyes from cryogenic gas.
prototypes 2 every two weeksDevice
Application on brown spots located on the face and/or the hand (6 treatments during the study). An operator previously trained by the dermatologist will apply the study device to the patient's face or/and hand. Subjects will be lying down, and the prototypes will be administered upside down for the applications on the face and sitting for the applications on the hands. For the application on the hands, the hands will be placed flat on the table and the prototypes will be applied upside down. During applications on the face, subjects will wear diving goggles protecting the eyes from cryogenic gas.
prototypes 3 every two weeksDevice
Application on brown spots located on the face and/or the hand (6 treatments during the study). An operator previously trained by the dermatologist will apply the study device to the patient's face or/and hand. Subjects will be lying down, and the prototypes will be administered upside down for the applications on the face and sitting for the applications on the hands. For the application on the hands, the hands will be placed flat on the table and the prototypes will be applied upside down. During applications on the face, subjects will wear diving goggles protecting the eyes from cryogenic gas.
| Study group | Role | What they receive |
|---|---|---|
| Condition 1 :prototypes 1 everyday | Experimental | Application on the brown spots of the face and the hands for the prototypes 1 at D0,D1,D2,D3,D4 and D5 Receives: Device: prototypes 1 everyday |
| Condition 2 : prototypes 1 every week | Experimental | Application on the brown spots of the face and the hands for the prototypes 1 at D0,D7,D14,D21,D28, D35, D42, D49, D56, D63, D70 and D77. Receives: Device: prototypes 1 every week |
| Condition 3 : prototypes 1 every two weeks | Experimental | Application on the brown spots of the face and the hands for the prototypes 1 at D0,D14,D28, D42, D56 and D70 Receives: Device: prototypes 1 every two weeks |
| Condition 4 : prototypes 2 every two weeks | Experimental | Application on the brown spots of the face and the hands for the prototypes 2 at D0,D14,D28, D42, D56 and D70 Receives: Device: prototypes 2 every two weeks |
| Condition 5 : prototypes 3 every two weeks | Experimental | Application on the brown spots of the face and the hands for the prototypes 3 at D0,D14,D28, D42, D56 and D70 Receives: Device: prototypes 3 every two weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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;
- Almost clear of hyperpigmentation;
- mild, but noticeable hyperpigmentation;
- moderate hyperpigmentation (medium brown in quality);
- severe hyperpigmentation (dark brown in quality);
- very severe hyperpigmentation (very dark brown, almost black in quality).
Measured: Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 63, Day 70, Day 77, Day 91, 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;
- very slight area of hypopigmentation of very small size and very slightly fairer than the surrounding skin;
- slight area of hypopigmentation of small size and slightly fairer than the surrounding skin;
- moderate : area of hypopigmentation of moderate size and much fairer than the surrounding skin;
- severe : area of hypopigmentation of large size and much fairer than the surrounding skin.
Measured: Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 63, Day 70, Day 77, Day 91, Day 0 + 6 months
Change from baseline skin appearance - expected events
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;
- very mild;
- mild;
- moderate;
- severe.
Measured: Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 63, Day 70, Day 77, Day 91, 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;
- very mild;
- mild;
- moderate;
- severe.
Measured: Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 63, Day 70, Day 77, Day 91, 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".
Measured: Day 0
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.
Measured: Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 63, Day 70, Day 77, Day 91, Day 0 + 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start1 Sep 2023 (estimated)
- Primary completion29 Feb 2024 (estimated)
- Study completion29 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solar LentigoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cryonove Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CEISO
- Responsible party
- Sponsor
- Investigators
- Michel Cadot, Principal investigator, Laboratoir BIO-EC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05886010
- Sponsor's protocol ID
- CS5_4
- Status last verified
- May 2023
- First submitted
- 23 May 2023
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Performance and Tolerance of Cyto-selective Difluoroethane-based Cryotherapy in th Treatment of Brown Spots (Solar and Senile Lentigines, Post-Inflammatory Hyperpigmentation) on the Face and Hands of Asian Ethnicity Skins
- ClinicalTrials.gov ID
- NCT05886010
- Acronym / sponsor ID
- CS5_4
- Conditions
- Solar Lentigo, Senile Lentigo
- Keywords
- Cryotherapy, Hyperpigmentation, Skin Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Cryonove PharmaIndustry (pharma, biotech, devices)
- Collaborators
- CEISO
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 29 Feb 2024 (estimated)
- Study completion
- 29 Feb 2024 (estimated)
- First posted
- 2 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
CS5_4 study aim to evaluate the performance and the tolerance of 3 prototypes of cyto-selective cryotherapy treatments applied on the brown spots on the face and hands of asian ethnicity skins (chinese). A brown spot is defined as solar or senile lentigo (SSL) and post-inflammatory hyperpigmentation (PIH).
Each treatment corresponds to a combination of a specific sequence of cryogenic spray and of a frequency of application. Each spot will be treated by a defined prototype (always the same device on the same spot all along the study).
The study will evaluate the following prototype :
- Prototypes 1
- Prototypes 2
- Prototypes 3
Detailed description
Rational :
Solar/senile lentigo (SSL) 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/senile lentigos or lentigines are very common, especially in people over the age of 40 years. Solar/senile lentigines are found as groups of similar lesions on sun-exposed sites, particularly the face or the back of hands.
Post-inflammatory hyperpigmentation (PIH) is an area of darker skin that remains after a pimple or wound heals. The discoloration is due to the production of excess melanin (pigment) as part of the skin's natural response to inflammation.
CRYONOVE is a medical device intended to induce a cyto-selective cryogenic action on melanocytes to remove brown spots resulting from solar or senile lentigines, post-inflammatory hyperpigmentation and melasma on the face and body.
Cryotherapy is more and more used to improve skin appearance and currently used to treat lentigo spot. Devices using difluoroethane, manufactured by CRYONOVE PHARMA, are already available on the local and international markets, e.g. CRYOBEAUTY MAINS and CRYOBEAUTY CORPS.
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, it seems interesting for the sponsor to select other sequences of a cryogenic spray (3 prototypes of devices for face and hands used according to different frequencies of application, i.e., 5 conditions evaluated) which could be used for lentigo and post inflammatory hyperpigmentation treatment in Asian Ethnicity Skin with a same benefit for the consumers without any safety outcomes.
Design:
The study performed is a proof of concept, exploratory, interventional, monocentric, randomized and single blinded
Intervention :
3 prototypes of devices are evaluated in 5 different conditions. Each treatment corresponds to a combination of a specific sequence of cryogenic spray and of a frequency of application.
For the conditions 1, 3, 4 and 5, each spot will be treated 6 times during the study :
- Every day from D0 and thus until D5 (condition 1);
- Every two weeks: at D0, D14, D28, D42, D56 and at D70 (condition 3):
- Every two weeks: at D0, D14, D28, D42, D56 and at D70 (condition 4);
- Every two weeks: at D0, D14, D28, D42, D56 and at D70 (condition 5).
For the condition 2, each spot will be treated 12 times during the study:
- Every week: at D0, D7, D14, D21, D28, D35, D42, D49, D56, D63, D70 and at D77 (condition 2);
120 participant will be included in the study. Overall, this study leads to treat 240 face spots (PIH, SSL) and 40 hands spots (SSL) with 3 prototypes having different temperature and kinetic.
Prior to any study device application, the dermatologist will assess the adverse events and will decide if the period between two consecutive applications should be extended or not.The dermatologist will verify that the skin has not been treated by cosmetic products (no presence of cream that could interfere with the treatment) and is dry.
An operator previously trained by the dermatologist will apply the study device to the patient's face or hands. Subjects will be lying down, and the device will be administered upside down. During applications on the face, subjects will wear diving goggles protecting the eyes from cryogenic gas. For the application on the hands, the hands will be placed flat on the table and the prototypes will be applied upside down.The treatment will be stoped after the disappearance of the spot.
The patient follow-up visits are from Day 0 to 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Condition 1 :prototypes 1 everyday | Experimental | Device: prototypes 1 everydayApplication on the brown spots of the face and the hands for the prototypes 1 at D0,D1,D2,D3,D4 and D5 |
| Condition 2 : prototypes 1 every week | Experimental | Device: prototypes 1 every weekApplication on the brown spots of the face and the hands for the prototypes 1 at D0,D7,D14,D21,D28, D35, D42, D49, D56, D63, D70 and D77. |
| Condition 3 : prototypes 1 every two weeks | Experimental | Device: prototypes 1 every two weeksApplication on the brown spots of the face and the hands for the prototypes 1 at D0,D14,D28, D42, D56 and D70 |
| Condition 4 : prototypes 2 every two weeks | Experimental | Device: prototypes 2 every two weeksApplication on the brown spots of the face and the hands for the prototypes 2 at D0,D14,D28, D42, D56 and D70 |
| Condition 5 : prototypes 3 every two weeks | Experimental | Device: prototypes 3 every two weeksApplication on the brown spots of the face and the hands for the prototypes 3 at D0,D14,D28, D42, D56 and D70 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female or male,
- Chinese ethnicity skins,
- Ages between 18 years old and 75 years old,
- Phototype II or III (according to Fitzpatrick scale),
- Featuring brown spots ≥ 3 and ≤ 6 mm in diameter
Key exclusion criteria (14 listed)
- Having performed cosmetic treatments (exfoliants, scrubs or self-tanners, manicures, facials, UV ...) in the month before the start of the study where the prototypes will be applied.
- Having applied a depraving product in the month prior to the start of the study, where the prototypes will be applied.
- Having performed cosmetic treatments in a dermatologist (laser, Intense Pulsed Light (IPL), peeling, creams, cryotherapy ...) in the last 6 months where the prototypes will be applied (see restrictions paragraph).
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prototypes 1 everydayApplication on brown spots located on the face and/or the hand (6 treatments during the study). An operator previously trained by the dermatologist will apply the study device to the patient's face or/and hand. Subjects will be lying down, and the prototypes will be administered upside down for the applications on the face and sitting for the applications on the hands. For the application on the hands, the hands will be placed flat on the table and the prototypes will be applied upside down. During applications on the face, subjects will wear diving goggles protecting the eyes from cryogenic gas. | Device | Condition 1 :prototypes 1 everyday |
| prototypes 1 every weekApplication on brown spots located on the face and/or the hand (12 treatments during the study). An operator previously trained by the dermatologist will apply the study device to the patient's face or/and hand. Subjects will be lying down, and the prototypes will be administered upside down for the applications on the face and sitting for the applications on the hands. For the application on the hands, the hands will be placed flat on the table and the prototypes will be applied upside down. During applications on the face, subjects will wear diving goggles protecting the eyes from cryogenic gas. | Device | Condition 2 : prototypes 1 every week |
| prototypes 1 every two weeksApplication on brown spots located on the face and/or the hand (6 treatments during the study). An operator previously trained by the dermatologist will apply the study device to the patient's face or/and hand. Subjects will be lying down, and the prototypes will be administered upside down for the applications on the face and sitting for the applications on the hands. For the application on the hands, the hands will be placed flat on the table and the prototypes will be applied upside down. During applications on the face, subjects will wear diving goggles protecting the eyes from cryogenic gas. | Device | Condition 3 : prototypes 1 every two weeks |
| prototypes 2 every two weeksApplication on brown spots located on the face and/or the hand (6 treatments during the study). An operator previously trained by the dermatologist will apply the study device to the patient's face or/and hand. Subjects will be lying down, and the prototypes will be administered upside down for the applications on the face and sitting for the applications on the hands. For the application on the hands, the hands will be placed flat on the table and the prototypes will be applied upside down. During applications on the face, subjects will wear diving goggles protecting the eyes from cryogenic gas. | Device | Condition 4 : prototypes 2 every two weeks |
| prototypes 3 every two weeksApplication on brown spots located on the face and/or the hand (6 treatments during the study). An operator previously trained by the dermatologist will apply the study device to the patient's face or/and hand. Subjects will be lying down, and the prototypes will be administered upside down for the applications on the face and sitting for the applications on the hands. For the application on the hands, the hands will be placed flat on the table and the prototypes will be applied upside down. During applications on the face, subjects will wear diving goggles protecting the eyes from cryogenic gas. | Device | Condition 5 : prototypes 3 every two weeks |
Primary outcome
Change from baseline skin hyperpigmentation
Time frame: Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 63, Day 70, Day 77, Day 91, 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 hypopigmentation
Time frame: Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 63, Day 70, Day 77, Day 91, 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 appearance - expected events
Time frame: Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 63, Day 70, Day 77, Day 91, 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.
Change from baseline skin sensation
Time frame: Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 63, Day 70, Day 77, Day 91, 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.
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. 10 is the first end being the "maximum pain imaginable" and 0 is the other end being "no pain".
Change from baseline spots visibility
Time frame: Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 63, Day 70, Day 77, Day 91, Day 0 + 6 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2023.
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CLINICAL INVESTIGATION TO EVALUATE THE EFFICACY AND SAFETY OF EPILADY PROTOTYPE DEVICE FOLLOWED BY APPLICATION OF A TOPICAL FORMULA ON DEPIGMENTATION OF LENTIGO SPOTS
Solar Lentigo
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel Cadot principal investigator
Laboratoir BIO-EC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prototypes 1 everyday, prototypes 1 every week and prototypes 1 every two weeks in people with Solar Lentigo and Senile Lentigo, run by Cryonove Pharma at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Léa SESTITO (0169414764, l.sestito@bio-ec.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline skin hyperpigmentation (time frame: Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 63, Day 70, Day 77, Day 91, Day 0 + 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2023.