Solar LentigoAGILE2NCT05203263
Tolerance and Mode of Administration of Cyto-selective Cryotherapy Treatments in Face Brown Spots: Proof of Concept
A study testing (810A-v1) device prototype, (810B-v1) device prototype and (810C-v1) device prototype in people with Solar Lentigo, run by Cryonove Pharma at 1 site in Ukraine.
Trial summary
Solar lentigos or lentigines are harmless patch of darkened skin, of different sizes and colors, due to the exposure to UV radiation. They are very common, especially in people over the age of 40 years old. Read more about this study
- Who is it for?
- Ages 30 to 75 years, women only
- Conditions the study is for
- Solar Lentigo
- What is being tested?
- (810A-v1) device prototype, (810B-v1) device prototype and (810C-v1) device prototype
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUkraine
- Study dates
- 15 Dec 2021to 15 Feb 2022
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Phototype II et III (according with Fitzpatrick scale)
- Featuring brown spots (solar lentigos) on the face ≥ 3mm to 6 mm in diameter (at least 2-3 spots per subject).
- 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 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, facials, UV...) in the month before the start of the study, at the level of the face.
- Having applied a depraving product in the month prior to the start of the study, at the level of the face.
- Having performed cosmetic treatments in a dermatologist (laser, intense pulsed light, peeling, creams, cryotherapy ...), at the level of the face 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 (under guardianship, under curatorship, safeguarding justice...).
- People unable to read and write Ukrainian 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 use effective methods of contraception.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Tolerance and the Mode of Administration of Cyto-selective Difluoroethane-based Cryotherapy in the Treatment of Brown Spots
Solar lentigos or lentigines are harmless patch of darkened skin, of different sizes and colors, due to the exposure to UV radiation. They are very common, especially in people over the age of 40 years old. Solar lentigines appears as clusters of similar lesions on sun-exposed sites, such as the face or the back of the hands.
Conventional cryotherapy is increasingly used to improve the skin appearance and especially to treat lentigo spots. However, the application of conventional cryotherapy is followed by temporary side effects including pain at application, hypo- and hyperpigmentation, crust, scars, burns, erythema... for a few days after administration and that can persist during several months.
Read more
In this context, the sponsor has developed a treatment using cyto-selective cryotherapy, that treats only the melanocytes responsable of brown spots while preserving other cells of the epidermis. Several sequences of pulverization of cryogenic gas have been designed. It seems interesting for the sponsor to study some ways of applications of the selected sequences. i.e. 5 conditions evaluated) that could be used for the treatment of lentigos with the same clinical benefit and with better safety results for patients .
(CS4_2) proof of concept, interventional, monocentric, randomized and double blinded study, aims to evaluate the tolerance and the mode of administration of cyto-selective difluoroethane-based cryotherapy in the treatment of brown spots.
The main objective of the study is to evaluate the tolerance and to adjust the mode of administration of 3 different cryotherapy treatments (3 prototypes) applied on the brown spots of the face. Each treatment corresponds to a specific sequence of a cryogenic spray.
Read the detailed description
Prototypes (810A-v1), (810B-v1) and (810C-v1) will be applied on brown spots located on the face. Regarding the randomization list, each spot will be treated by a defined prototype / device (same prototype /device will be used to treat the same spot all along the study).
Each spot will be treated 6 times during the study:
- At Day 0, Day 1, Day 2, Day 3 Day 4 and Day 5 for the prototypes (810A-v1) (condition 1) and (810B-v1) (condition 2).
- At Day 0, Day 7, Day 14, Day 21, Day 28 and Day 35 for the prototypes (810A-v1) (condition 3) and (810C-v1) (condition 4).
- At Day 0, Day 14, Day 28, Day 42, Day 56 and Day 70 for the prototype (810C-v1) (condition 5, considered as reference).
Prior to any study device application, the dermatologist will assess the adverse events and decide whether the period between two consecutive applications should be extended or not. The dermatologist will verify that the skin has not been treated with cosmetic products (no cream, peeling, dermabrasion, laser treatment... that could interfere with the treatment) and that is dry.
The procedure will take place at the investigation site. An operator previously trained by the dermatologist will apply the study device to the patient's brown spots.
Subjects will lie down and the device will be administered upside down. During the applications, subjects will wear diving goggles (provided by the CRO) to protect the eyes from the cryogenic gas.
Treatments will be stopped when a total of 6 applications for the prototypes will be delivered or as soon as a spot will be considered disappeared by the investigator. Otherwise the study will continue (tolerance report, etc.) until all conditions are completed.
- Conditions
- Solar Lentigo
- Being tested
- (810A-v1) device prototype, (810B-v1) device prototype, (810C-v1) device prototype
- Keywords
- Lentigo, Melanosis, melanocyte, melanosome, Hyperpigmentation, Pigmentation Disorders, Skin Diseases
- Medical subject headings
- Lentigo, Melanosis, Hyperpigmentation, Pigmentation Disorders, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(810A-v1) device prototypeDevice
Sequence with Serial Number from (810-v1 101) to (810-v1 140). Application on brown spots located on the face (6 treatments during the study).
(810B-v1) device prototypeDevice
Sequence with Serial Number (810-v1 141) to (810-v1 160). Application on brown spots located on the face (6 treatments during the study).
(810C-v1) device prototypeDevice
Sequence with Serial Number (810-v1 161) to (810-v1 200). Application on brown spots located on the face (6 treatments during the study).
| Study group | Role | What they receive |
|---|---|---|
| Condition 1 : Prototype (810A-v1) and Frequency of application 1 | Experimental | Application of the prototype (810A-v1) at Day 0, Day 1, Day 2, Day 3, Day 4 and Day 5. Receives: Device: (810A-v1) device prototype |
| Condition 2 :Prototype (810B-v1) and Frequency of application 1 | Experimental | Application of the prototype (810B-v1) at Day 0, Day 1, Day 2, Day 3, Day 4 and Day 5. Receives: Device: (810B-v1) device prototype |
| Condition 3 : Prototype (810A-v1) and Frequency of application 2 | Experimental | Application of the prototype (810A-v1) at Day 0, Day 7, Day 14, Day 21, Day 28 and Day 35. Receives: Device: (810A-v1) device prototype |
| Condition 4 : Prototype (810C-v1) and Frequency of application 2 | Experimental | Application of the prototype (810C-v1) at Day 0, Day 7, Day 14, Day 21, Day 28 and Day 35. Receives: Device: (810C-v1) device prototype |
| Condition 5 : Prototype (810C-v1) and Frequency of application 3 | Active comparator | Application of the prototype (810C-v1) at Day 0, Day 14, Day 28, Day 42, Day 56 and Day 70. Receives: Device: (810C-v1) device prototype |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline skin hyperpigmentation
This outcome is a tolerance assessment criteria. Clinical evaluation of hyperpigmentation on each selected and treated lentigo spot will be performed by a Dermatologist using the Investigator's Global Assessment likert 6 points scale ranged from 0 to 5: 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: - Conditions 1 and 2: Day0, Day1, Day2, Day3, Day4, Day5, Day14 and Day28 - Conditions 3 and 4: Day0, Day1, Day2, Day3, Day7, Day14, Day21, Day28, Day 35 and Day42 - Condition 5 (Ref): Day0, Day1, Day2, Day3, Day14, Day28, Day42, Day56, Day70 and Day84
Change from baseline skin hypopigmentation
This outcome is a tolerance assessment criteria. Clinical evaluation of hypopigmentation on each selected and treated lentigo spot will be performed by a Dermatologist using a likert 5 points scale ranged from 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: - Conditions 1 and 2: Day0, Day1, Day2, Day3, Day4, Day5, Day14 and Day28 - Conditions 3 and 4: Day0, Day1, Day2, Day3, Day7, Day14, Day21, Day28, Day35 and Day42 -Condition 5 (Ref): Day0, Day1, Day2, Day3, Day14, Day28, Day42, Day56, Day70 and Day84
Change from baseline skin appearance (Edemas, blisters, bubbles, scars, erythema)
This outcome is a tolerance assessment criteria. Clinical visual evaluation of selected lentigo spots and surrounded spotless skin area around the spot skin will be performed. A likert scale in 5 points (0 to 4) will be used : 0=none; 1=very mild; 2=mild; 3=moderate; 4=severe.
Measured: - Conditions 1 and 2: Day0, Day1, Day2, Day3, Day4, Day5, Day14 and Day28 - Conditions 3 and 4: Day0, Day1, Day2, Day3, Day7, Day14, Day21, Day28, Day35 and Day42 -Condition 5 (Ref): Day0, Day1, Day2, Day3, Day14, Day28, Day42, Day56, Day70 and Day84
Change from baseline skin sensation (itching, tingling, burning sensations)
This outcome is a tolerance assessment criteria. Clinical visual evaluation of selected lentigo spots and around the spot skin will be performed. A likert scale in 5 points (0 to 4) will be used : 0=none; 1=very mild; 2=mild; 3=moderate; 4=severe.
Measured: - Conditions 1 and 2: Day0, Day1, Day2, Day3, Day4, Day5, Day14 and Day28 - Conditions 3 and 4: Day0, Day1, Day2, Day3, Day7, Day14, Day21, Day28, Day35 and Day42 -Condition 5 (Ref): Day0, Day1, Day2, Day3, Day14, Day28, Day42, Day56, Day70 and Day84
Post treatment pain
This outcome is a tolerance assessment criteria. 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 (Visual Analogue Scale) 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).
Measured: Day 0 (Time1 defined as 15 minutes post-treatment)
Change from baseline skin color
This outcome is a performance assessment criteria. 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 (provided by the Sponsor or L'Oréal) in standardized position and lighting.
Measured: - Conditions 1 and 2: Day0, Day14 and Day28 - Conditions 3 and 4: Day0, Day7, Day14, Day21, Day28, Day35 and Day42 - Condition 5 (Ref): Day0, Day14, Day28, Day42, Day56, Day70 and Day84
Change from baseline spots visibility
This outcome is a performance assessment criteria. Standardized photographs by C-Cube® acquisition will be taken before the treatment at each visit of each spot using a dermatoscope C-cube (device which allows realizing high resolution skin pictures (10 million pixels 2D capture (UHD)).
Measured: - Conditions 1 and 2: Day0, Day1, Day2, Day3, Day4, Day5, Day14 and Day28 - Conditions 3 and 4: Day0, Day1, Day2, Day3, Day7, Day14, Day21, D28, Day35 and Day42 - Condition 5 (Ref): Day0, Day1, Day2, Day3, Day14, Day28, Day42, Day56, Day70 and Day84
Secondary outcomes (1)
Efficacy self-assessment
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.
Measured: - Conditions 1 and 2: Day0, Day1, Day2, Day3, Day4, Day5, Day14 and Day28 - Conditions 3 and 4: Day0, Day1, Day2, Day3, Day7, Day14, Day21, Day28, Day35 and Day42 - Condition 5 (Ref): Day0, Day1, Day2, Day3, Day14, Day28, Day42, Day56, Day70 and Day84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start15 Dec 2021
- Primary completion15 Feb 2022
- Study completion15 Feb 2022
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, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cryonove Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dermatech, CEISO, INNOVSOLUTION
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05203263
- Sponsor's protocol ID
- (CS4_2) AGILE 2 N° 21D588A0002
- Acronym
- AGILE2
- Status last verified
- Jan 2022
- First submitted
- 13 Dec 2021
- Last updated
- 19 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Tolerance and the Mode of Administration of Cyto-selective Difluoroethane-based Cryotherapy in the Treatment of Brown Spots
- ClinicalTrials.gov ID
- NCT05203263
- Acronym / sponsor ID
- AGILE2 / (CS4_2) AGILE 2 N° 21D588A0002
- Conditions
- Solar Lentigo
- Keywords
- Lentigo, Melanosis, melanocyte, melanosome, Hyperpigmentation, Pigmentation Disorders, Skin Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Cryonove PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Dermatech, CEISO, INNOVSOLUTION
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 15 Feb 2022 (actual)
- First posted
- 24 Jan 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.
Solar lentigos or lentigines are harmless patch of darkened skin, of different sizes and colors, due to the exposure to UV radiation. They are very common, especially in people over the age of 40 years old. Solar lentigines appears as clusters of similar lesions on sun-exposed sites, such as the face or the back of the hands.
Conventional cryotherapy is increasingly used to improve the skin appearance and especially to treat lentigo spots. However, the application of conventional cryotherapy is followed by temporary side effects including pain at application, hypo- and hyperpigmentation, crust, scars, burns, erythema... for a few days after administration and that can persist during several months.
In this context, the sponsor has developed a treatment using cyto-selective cryotherapy, that treats only the melanocytes responsable of brown spots while preserving other cells of the epidermis. Several sequences of pulverization of cryogenic gas have been designed. It seems interesting for the sponsor to study some ways of applications of the selected sequences. i.e. 5 conditions evaluated) that could be used for the treatment of lentigos with the same clinical benefit and with better safety results for patients .
(CS4_2) proof of concept, interventional, monocentric, randomized and double blinded study, aims to evaluate the tolerance and the mode of administration of cyto-selective difluoroethane-based cryotherapy in the treatment of brown spots.
The main objective of the study is to evaluate the tolerance and to adjust the mode of administration of 3 different cryotherapy treatments (3 prototypes) applied on the brown spots of the face. Each treatment corresponds to a specific sequence of a cryogenic spray.
Detailed description
Prototypes (810A-v1), (810B-v1) and (810C-v1) will be applied on brown spots located on the face. Regarding the randomization list, each spot will be treated by a defined prototype / device (same prototype /device will be used to treat the same spot all along the study).
Each spot will be treated 6 times during the study:
- At Day 0, Day 1, Day 2, Day 3 Day 4 and Day 5 for the prototypes (810A-v1) (condition 1) and (810B-v1) (condition 2).
- At Day 0, Day 7, Day 14, Day 21, Day 28 and Day 35 for the prototypes (810A-v1) (condition 3) and (810C-v1) (condition 4).
- At Day 0, Day 14, Day 28, Day 42, Day 56 and Day 70 for the prototype (810C-v1) (condition 5, considered as reference).
Prior to any study device application, the dermatologist will assess the adverse events and decide whether the period between two consecutive applications should be extended or not. The dermatologist will verify that the skin has not been treated with cosmetic products (no cream, peeling, dermabrasion, laser treatment... that could interfere with the treatment) and that is dry.
The procedure will take place at the investigation site. An operator previously trained by the dermatologist will apply the study device to the patient's brown spots.
Subjects will lie down and the device will be administered upside down. During the applications, subjects will wear diving goggles (provided by the CRO) to protect the eyes from the cryogenic gas.
Treatments will be stopped when a total of 6 applications for the prototypes will be delivered or as soon as a spot will be considered disappeared by the investigator. Otherwise the study will continue (tolerance report, etc.) until all conditions are completed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Condition 1 : Prototype (810A-v1) and Frequency of application 1 | Experimental | Device: (810A-v1) device prototypeApplication of the prototype (810A-v1) at Day 0, Day 1, Day 2, Day 3, Day 4 and Day 5. |
| Condition 2 :Prototype (810B-v1) and Frequency of application 1 | Experimental | Device: (810B-v1) device prototypeApplication of the prototype (810B-v1) at Day 0, Day 1, Day 2, Day 3, Day 4 and Day 5. |
| Condition 3 : Prototype (810A-v1) and Frequency of application 2 | Experimental | Device: (810A-v1) device prototypeApplication of the prototype (810A-v1) at Day 0, Day 7, Day 14, Day 21, Day 28 and Day 35. |
| Condition 4 : Prototype (810C-v1) and Frequency of application 2 | Experimental | Device: (810C-v1) device prototypeApplication of the prototype (810C-v1) at Day 0, Day 7, Day 14, Day 21, Day 28 and Day 35. |
| Condition 5 : Prototype (810C-v1) and Frequency of application 3 | Active comparator | Device: (810C-v1) device prototypeApplication of the prototype (810C-v1) at Day 0, Day 14, Day 28, Day 42, Day 56 and Day 70. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Phototype II et III (according with Fitzpatrick scale)
- Featuring brown spots (solar lentigos) on the face ≥ 3mm to 6 mm in diameter (at least 2-3 spots per subject).
- 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 participation in the study.
Key exclusion criteria (14 listed)
- Having performed cosmetic treatments (exfoliants, scrubs or self-tanners, facials, UV...) in the month before the start of the study, at the level of the face.
- Having applied a depraving product in the month prior to the start of the study, at the level of the face.
- Having performed cosmetic treatments in a dermatologist (laser, intense pulsed light, peeling, creams, cryotherapy ...), at the level of the face 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 |
|---|---|---|
| (810A-v1) device prototypeSequence with Serial Number from (810-v1 101) to (810-v1 140). Application on brown spots located on the face (6 treatments during the study). | Device | Condition 1 : Prototype (810A-v1) and Frequency of application 1, Condition 3 : Prototype (810A-v1) and Frequency of application 2 |
| (810B-v1) device prototypeSequence with Serial Number (810-v1 141) to (810-v1 160). Application on brown spots located on the face (6 treatments during the study). | Device | Condition 2 :Prototype (810B-v1) and Frequency of application 1 |
| (810C-v1) device prototypeSequence with Serial Number (810-v1 161) to (810-v1 200). Application on brown spots located on the face (6 treatments during the study). | Device | Condition 4 : Prototype (810C-v1) and Frequency of application 2, Condition 5 : Prototype (810C-v1) and Frequency of application 3 |
Primary outcome
Change from baseline skin hyperpigmentation
Time frame: - Conditions 1 and 2: Day0, Day1, Day2, Day3, Day4, Day5, Day14 and Day28 - Conditions 3 and 4: Day0, Day1, Day2, Day3, Day7, Day14, Day21, Day28, Day 35 and Day42 - Condition 5 (Ref): Day0, Day1, Day2, Day3, Day14, Day28, Day42, Day56, Day70 and Day84
This outcome is a tolerance assessment criteria. Clinical evaluation of hyperpigmentation on each selected and treated lentigo spot will be performed by a Dermatologist using the Investigator's Global Assessment likert 6 points scale ranged from 0 to 5: 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: - Conditions 1 and 2: Day0, Day1, Day2, Day3, Day4, Day5, Day14 and Day28 - Conditions 3 and 4: Day0, Day1, Day2, Day3, Day7, Day14, Day21, Day28, Day35 and Day42 -Condition 5 (Ref): Day0, Day1, Day2, Day3, Day14, Day28, Day42, Day56, Day70 and Day84
This outcome is a tolerance assessment criteria. Clinical evaluation of hypopigmentation on each selected and treated lentigo spot will be performed by a Dermatologist using a likert 5 points scale ranged from 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 (Edemas, blisters, bubbles, scars, erythema)
Time frame: - Conditions 1 and 2: Day0, Day1, Day2, Day3, Day4, Day5, Day14 and Day28 - Conditions 3 and 4: Day0, Day1, Day2, Day3, Day7, Day14, Day21, Day28, Day35 and Day42 -Condition 5 (Ref): Day0, Day1, Day2, Day3, Day14, Day28, Day42, Day56, Day70 and Day84
This outcome is a tolerance assessment criteria. Clinical visual evaluation of selected lentigo spots and surrounded spotless skin area around the spot skin will be performed. A likert 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 (itching, tingling, burning sensations)
Time frame: - Conditions 1 and 2: Day0, Day1, Day2, Day3, Day4, Day5, Day14 and Day28 - Conditions 3 and 4: Day0, Day1, Day2, Day3, Day7, Day14, Day21, Day28, Day35 and Day42 -Condition 5 (Ref): Day0, Day1, Day2, Day3, Day14, Day28, Day42, Day56, Day70 and Day84
This outcome is a tolerance assessment criteria. Clinical visual evaluation of selected lentigo spots and around the spot skin will be performed. A likert scale in 5 points (0 to 4) will be used : 0=none; 1=very mild; 2=mild; 3=moderate; 4=severe.
Post treatment pain
Time frame: Day 0 (Time1 defined as 15 minutes post-treatment)
This outcome is a tolerance assessment criteria. 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 (Visual Analogue Scale) 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).
Change from baseline skin color
Time frame: - Conditions 1 and 2: Day0, Day14 and Day28 - Conditions 3 and 4: Day0, Day7, Day14, Day21, Day28, Day35 and Day42 - Condition 5 (Ref): Day0, Day14, Day28, Day42, Day56, Day70 and Day84
This outcome is a performance assessment criteria. 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 (provided by the Sponsor or L'Oréal) in standardized position and lighting.
Change from baseline spots visibility
Time frame: - Conditions 1 and 2: Day0, Day1, Day2, Day3, Day4, Day5, Day14 and Day28 - Conditions 3 and 4: Day0, Day1, Day2, Day3, Day7, Day14, Day21, D28, Day35 and Day42 - Condition 5 (Ref): Day0, Day1, Day2, Day3, Day14, Day28, Day42, Day56, Day70 and Day84
This outcome is a performance assessment criteria. Standardized photographs by C-Cube® acquisition will be taken before the treatment at each visit of each spot using a dermatoscope C-cube (device which allows realizing high resolution skin pictures (10 million pixels 2D capture (UHD)).
1 secondary outcome
Efficacy self-assessment
Time frame: - Conditions 1 and 2: Day0, Day1, Day2, Day3, Day4, Day5, Day14 and Day28 - Conditions 3 and 4: Day0, Day1, Day2, Day3, Day7, Day14, Day21, Day28, Day35 and Day42 - Condition 5 (Ref): Day0, Day1, Day2, Day3, Day14, Day28, Day42, Day56, Day70 and Day84
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 19 Aug 2022.
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Post-inflammatory Hyperpigmentation, Melasma
Not yet recruiting
Evaluation of Efficacy and Tolerabilty of MelaB3 Serum in Combination of 35% Glycolic Acid Peeling Compared to 35% Glycolic Acid Peeling Alone in Various Hyperpigmentation Conditions
Hyperpigmentation, Melasma
RecruitingObservational study
Melanoma of the Skin and Exposure to Solar Ultraviolet Radiation at Work in Modena Territory: a Case-control Study to Promote an Active Search and Prevention of Occupational Diseases Based on Recent INAIL Criteria
Skin Melanoma, Cutaneous Melanoma
Not yet recruiting
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing (810A-v1) device prototype, (810B-v1) device prototype and (810C-v1) device prototype in people with Solar Lentigo, run by Cryonove Pharma at 1 site in Ukraine.
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 6 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 19 Aug 2022. 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 Ukraine. 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: - Conditions 1 and 2: Day0, Day1, Day2, Day3, Day4, Day5, Day14 and Day28 - Conditions 3 and 4: Day0, Day1, Day2, Day3, Day7, Day14, Day21, Day28, Day 35 and Day42 - Condition 5 (Ref): Day0, Day1, Day2, Day3, Day14, Day28, Day42, Day56, Day70 and Day84). The study lists 7 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 19 Aug 2022.