Lentigo SolarNCT05600049
Tolerance and Performance of Cyto-selective Difluoroethane-based Cryotherapy in the Treatment of Brown Spots
A study testing Prototypes (815-v1 001) to (815-v1 050), Prototype (815-v1 051) to (815-v1 100) and Prototypes (815-v1 101) to (815-v1 150) in people with Lentigo Solar, run by Cryonove Pharma at 1 site in Georgia.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Lentigo Solar
- What is being tested?
- Prototypes (815-v1 001) to (815-v1 050), Prototype (815-v1 051) to (815-v1 100) and Prototypes (815-v1 101) to (815-v1 150)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteGeorgia
- Study dates
- 21 Oct 2022to 8 Jun 2023
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female or male.
- Ages 30 to 75.
- 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.
Who cannot join
- 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.
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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 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Tolerance and Performance (Mode of Administration) of Cyto-selective Difluoroethane-based Cryotherapy in the Treatment of Brown Spots
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)
Read the 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.
Design:
The study is a proof of performance designed to be interventional, monocentric, randomized and double blinded.
Intervention:
Three prototypes of devices are evaluated in 4 different conditions. A total of 168 brown spots are needed (84 brown spots on the face and 84 brown spots on the hands). Each treatment corresponds to a combination of a specific sequence of a cryogenic spray and of a frequency of application.
Prototypes (815-v1 001) to (815-v1 200) will be applied on brown spots located on the face and/or hands. Each spot will be treated six times by a defined prototype (always the same prototype on the same spot all along the study) according to specific frequencies (evry day, every week or every 2 weeks).The application order of the different prototypes will be defined by randomization.
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/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.
The patient follow-up visits are from Day 0 to 6 months.
- Conditions
- Lentigo Solar
- Being tested
- Prototypes (815-v1 001) to (815-v1 050), Prototype (815-v1 051) to (815-v1 100), Prototypes (815-v1 101) to (815-v1 150), Prototypes (815-v1 151) to (815-v1 200)
- 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 (815-v1 001) to (815-v1 050)Device
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.
Prototype (815-v1 051) to (815-v1 100)Device
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 (815-v1 101) to (815-v1 150)Device
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 (815-v1 151) to (815-v1 200)Device
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 from (815-v1 001) to (815-v1 050) every day | Experimental | 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. Receives: Device: Prototypes (815-v1 001) to (815-v1 050) |
| Condition 2 : prototypes from (815-v1 051) to (815-v1 100) every week | Experimental | 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. Receives: Device: Prototype (815-v1 051) to (815-v1 100) |
| Conditions 3 : prototypes from (815-v1 101) to (815-v1 150) every two weeks | Experimental | 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. Receives: Device: Prototypes (815-v1 101) to (815-v1 150) |
| Condition 4 : prototypes from (815-v1 151) to (815-v1 200) every two weeks | Experimental | 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. Receives: Device: Prototypes (815-v1 151) to (815-v1 200) |
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; 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).
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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. One end is the "maximum pain imaginable". The other end is "no pain."
Measured: 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 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).
Measured: 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
Secondary outcomes (1)
Self assessment of skin appearance
The skin appearance will be assessed by subjects through a 3 items questionnaire.
It allows obtaining the subjective appraisal of subject on the treatments 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start21 Oct 2022
- Primary completion8 Jun 2023
- Study completion8 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lentigo SolarStudies 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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cryonove Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dermatech, CEISO, LTD HEALTH
- Responsible party
- Sponsor
- Investigators
- Lela BERIDZE, Principal investigator, LTD HEALTH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05600049
- Sponsor's protocol ID
- CS5_1
- Status last verified
- Jun 2023
- First submitted
- 26 Oct 2022
- Last updated
- 15 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 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Tolerance and Performance (Mode of Administration) of Cyto-selective Difluoroethane-based Cryotherapy in the Treatment of Brown Spots
- ClinicalTrials.gov ID
- NCT05600049
- Acronym / sponsor ID
- CS5_1
- Conditions
- Lentigo Solar
- Keywords
- Cryotherapy, Hyperpigmentation, Skin Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Cryonove PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Dermatech, CEISO, LTD HEALTH
- Study start
- 21 Oct 2022 (actual)
- Primary completion
- 8 Jun 2023 (actual)
- Study completion
- 8 Jun 2023 (actual)
- First posted
- 31 Oct 2022 (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_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.
Design:
The study is a proof of performance designed to be interventional, monocentric, randomized and double blinded.
Intervention:
Three prototypes of devices are evaluated in 4 different conditions. A total of 168 brown spots are needed (84 brown spots on the face and 84 brown spots on the hands). Each treatment corresponds to a combination of a specific sequence of a cryogenic spray and of a frequency of application.
Prototypes (815-v1 001) to (815-v1 200) will be applied on brown spots located on the face and/or hands. Each spot will be treated six times by a defined prototype (always the same prototype on the same spot all along the study) according to specific frequencies (evry day, every week or every 2 weeks).The application order of the different prototypes will be defined by randomization.
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/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.
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
- 4
| Arm | Type | Receives |
|---|---|---|
| Condition 1 : prototypes from (815-v1 001) to (815-v1 050) every day | Experimental | Device: Prototypes (815-v1 001) to (815-v1 050)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. |
| Condition 2 : prototypes from (815-v1 051) to (815-v1 100) every week | Experimental | Device: Prototype (815-v1 051) to (815-v1 100)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. |
| Conditions 3 : prototypes from (815-v1 101) to (815-v1 150) every two weeks | Experimental | Device: Prototypes (815-v1 101) to (815-v1 150)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. |
| Condition 4 : prototypes from (815-v1 151) to (815-v1 200) every two weeks | Experimental | Device: Prototypes (815-v1 151) to (815-v1 200)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. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female or male.
- Ages 30 to 75.
- 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.
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, 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.
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 (815-v1 001) to (815-v1 050)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. | Device | Condition 1 : prototypes from (815-v1 001) to (815-v1 050) every day |
| Prototype (815-v1 051) to (815-v1 100)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. | Device | Condition 2 : prototypes from (815-v1 051) to (815-v1 100) every week |
| Prototypes (815-v1 101) to (815-v1 150)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. | Device | Conditions 3 : prototypes from (815-v1 101) to (815-v1 150) every two weeks |
| Prototypes (815-v1 151) to (815-v1 200)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. | Device | Condition 4 : prototypes from (815-v1 151) to (815-v1 200) every two weeks |
Primary outcome
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 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 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.
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.
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 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).
1 secondary outcome
Self assessment of 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
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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.
Lela BERIDZE principal investigator
LTD HEALTH
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 (815-v1 001) to (815-v1 050), Prototype (815-v1 051) to (815-v1 100) and Prototypes (815-v1 101) to (815-v1 150) in people with Lentigo Solar, run by Cryonove Pharma at 1 site in Georgia.
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 8 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: finished, as of the sponsor's last update on 15 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 Georgia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 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 15 Jun 2023.