Lentigo SolarNCT05793619
Tolerance and Performance (Mode of Administration) of Cyto-selective Difluoroethane-based Cryotherapy in the Treatment of Brown Spots
A study testing Prototypes (816-v1 301) to (816-v1 355) every week and Prototypes (816-v1 301) to (816-v1 355) every two weeks in people with Lentigo Solar and Senile Lentigo, run by Cryonove Pharma at 1 site in Georgia.
Trial summary
CS5_8 study aim to evaluate the tolerance and to adjust the mode of administration of 2 different conditions of cryotherapy treatments applied on the brown spots of the face with 1 prototype (816-v1). Each treatment corresponds to a specific frequency of cryogenic spray application. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Lentigo Solar, Senile Lentigo
- What is being tested?
- Prototypes (816-v1 301) to (816-v1 355) every week and Prototypes (816-v1 301) to (816-v1 355) every two weeks
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGeorgia
- Study dates
- 4 Apr 2023to 26 Oct 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 ≥ 3 and ≤ 6 mm in diameter (at least 1 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 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, 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 Pulse 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 (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_8 study aim to evaluate the tolerance and to adjust the mode of administration of 2 different conditions of cryotherapy treatments applied on the brown spots of the face with 1 prototype (816-v1). Each treatment corresponds to a specific frequency of cryogenic spray application.
The study will evaluate the following prototype :
- Prototypes from (816-v1 301) to (816-v1 355)
Read the detailed description
Rational :
Solar/senile 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/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.
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, the sponsor selected other sequences of a cryogenic spray (1 prototype of devices for face used according to different frequencies of application, i.e. 2 conditions evaluated) which could be used for lentigo treatment with a same benefit for the consumers without any safety outcomes.
Design:
The study performed is a proof of performance designed to be exploratory, interventional study, monocentric, randomized and double blinded.
Intervention :
1 prototype of devices are evaluated in 2 different conditions. Each treatment corresponds to a specific frequency of cryogenic spray application. A total of 42 brown spots are needed (at least 1 brown spot on the face).The 42 brown spots will be randomized between the 2 conditions and will be attributed to subjects according to the number of spots identified by Investigator.
Prototypes (816-v1 301) to (816-v1 355) will be applied on brown pots located on the face. Each spot will be treated six times by a defined prototype (always the same device on the same spot all along the study) according to specific frequencies (every week or every two weeks).
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.
As the study will use prototypes, before each treatment, the prototype will be administered to any surface (in order to purge eventually the presence of air). An operator previously trained by the dermatologist will apply the study device to the patient's face.
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.
The patient follow-up visits are from Day 0 to 6 months.
- Conditions
- Lentigo Solar, Senile Lentigo
- Being tested
- Prototypes (816-v1 301) to (816-v1 355) every week, Prototypes (816-v1 301) to (816-v1 355) 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 (816-v1 301) to (816-v1 355) every weekDevice
Application on brown spots located on the face (6 treatments during the study). An operator previously trained by the dermatologist will apply the study device to the patient's face. Subjects will be lying down, and the prototypes will be administered upside down. During applications, subjects will wear diving goggles protecting the eyes from cryogenic gas.
Prototypes (816-v1 301) to (816-v1 355) every two weeksDevice
Application on brown spots located on the face (6 treatments during the study). An operator previously trained by the dermatologist will apply the study device to the patient's face. Subjects will be lying down, and the prototypes will be administered upside down. During applications, subjects will wear diving goggles protecting the eyes from cryogenic gas.
| Study group | Role | What they receive |
|---|---|---|
| Condition 1 : prototypes (816-v1 301) to (816-v1 355) every week | Experimental | Application on the brown spots of the face for the prototypes (816-v1 301) to (816-v1 355) at D0, D7, D14, D21, D28 and D35 Receives: Device: Prototypes (816-v1 301) to (816-v1 355) every week |
| Condition 2 : prototypes (816-v1 301) to (816-v1 355) every two weeks | Experimental | Application on the brown spots of the face for the prototypes (816-v1 301) to (816-v1 355) at D0, D14, D28, D42, D56 and D70 Receives: Device: Prototypes (816-v1 301) to (816-v1 355) 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 7, Day 14, Day 21, Day 28, Day 35, Day 42, 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;
- 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 7, Day 14, Day 21, Day 28, Day 35, Day 42, 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;
- very mild;
- mild;
- moderate;
- severe.
Measured: Day 0, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, 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;
- very mild;
- mild;
- moderate;
- 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. 10 is the first end being the "maximum pain imaginable" and 0 is the other end being "no pain".
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 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 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 spots color
L'OREAL Color-Chart is a visual mode of evaluation chart which includes 4 items :
- Color of lentigo spot
- Lightness of lentigo spot
- Color of spotless area
- Lightness of spotless area
The items color of lentigo spot and color of spotless area are using a scale redder to yellower in 7 points (G to M).
The items lightness of lentigo spot and lightness of spotless are using a scale lighter to darker in 15 points (5 to 19)
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 lentigines global improvement scale (LGIS) score
Lentigines Global Improvement Scale (LGIS) score will be used to assess the spots visibility
This is a 7-point scale :
- Completely clear - 0 - : No evidence of hyperpigmentation 100% improvement
- Almost clear - 1 - : Very significant clearance (about 90%); only minor evidence of hyperpigmentation remains
- Marked improvement - 2 - : Significant improvement (about 75%); score evidence of hyperpigmentation remains
- Moderate improvement - 3 - : intermediate between marked and slight improvement; about 50% improvement in the appearance of hyperpigmentation
- Slight improvement - 4 - : some improvement (about 25%); however significant evidence of hyperpigmentation remains
- No change - 5 - : Hyperpigmentation has not changed since baseline
- Worse - 6 - : Worse (hyperpigmentation is worse that at baseline)
Measured: Day 49 and Day 84
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 Mar 2023
- Study start4 Apr 2023
- Primary completion26 Oct 2023
- Study completion26 Oct 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
- 20 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
- NCT05793619
- Sponsor's protocol ID
- CS5_8
- Status last verified
- Jun 2023
- First submitted
- 20 Mar 2023
- Last updated
- 3 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 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
- NCT05793619
- Acronym / sponsor ID
- CS5_8
- Conditions
- Lentigo Solar, Senile Lentigo
- Keywords
- cryotherapy, hyperpigmentation, Skin Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cryonove PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Dermatech, CEISO, LTD HEALTH
- Study start
- 4 Apr 2023 (actual)
- Primary completion
- 26 Oct 2023 (actual)
- Study completion
- 26 Oct 2023 (actual)
- First posted
- 31 Mar 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_8 study aim to evaluate the tolerance and to adjust the mode of administration of 2 different conditions of cryotherapy treatments applied on the brown spots of the face with 1 prototype (816-v1). Each treatment corresponds to a specific frequency of cryogenic spray application.
The study will evaluate the following prototype :
- Prototypes from (816-v1 301) to (816-v1 355)
Detailed description
Rational :
Solar/senile 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/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.
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, the sponsor selected other sequences of a cryogenic spray (1 prototype of devices for face used according to different frequencies of application, i.e. 2 conditions evaluated) which could be used for lentigo treatment with a same benefit for the consumers without any safety outcomes.
Design:
The study performed is a proof of performance designed to be exploratory, interventional study, monocentric, randomized and double blinded.
Intervention :
1 prototype of devices are evaluated in 2 different conditions. Each treatment corresponds to a specific frequency of cryogenic spray application. A total of 42 brown spots are needed (at least 1 brown spot on the face).The 42 brown spots will be randomized between the 2 conditions and will be attributed to subjects according to the number of spots identified by Investigator.
Prototypes (816-v1 301) to (816-v1 355) will be applied on brown pots located on the face. Each spot will be treated six times by a defined prototype (always the same device on the same spot all along the study) according to specific frequencies (every week or every two weeks).
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.
As the study will use prototypes, before each treatment, the prototype will be administered to any surface (in order to purge eventually the presence of air). An operator previously trained by the dermatologist will apply the study device to the patient's face.
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.
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
- 2
| Arm | Type | Receives |
|---|---|---|
| Condition 1 : prototypes (816-v1 301) to (816-v1 355) every week | Experimental | Device: Prototypes (816-v1 301) to (816-v1 355) every weekApplication on the brown spots of the face for the prototypes (816-v1 301) to (816-v1 355) at D0, D7, D14, D21, D28 and D35 |
| Condition 2 : prototypes (816-v1 301) to (816-v1 355) every two weeks | Experimental | Device: Prototypes (816-v1 301) to (816-v1 355) every two weeksApplication on the brown spots of the face for the prototypes (816-v1 301) to (816-v1 355) 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 ≥ 3 and ≤ 6 mm in diameter (at least 1 spots per subject)
- 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, 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 Pulse 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 |
|---|---|---|
| Prototypes (816-v1 301) to (816-v1 355) every weekApplication on brown spots located on the face (6 treatments during the study). An operator previously trained by the dermatologist will apply the study device to the patient's face. Subjects will be lying down, and the prototypes will be administered upside down. During applications, subjects will wear diving goggles protecting the eyes from cryogenic gas. | Device | Condition 1 : prototypes (816-v1 301) to (816-v1 355) every week |
| Prototypes (816-v1 301) to (816-v1 355) every two weeksApplication on brown spots located on the face (6 treatments during the study). An operator previously trained by the dermatologist will apply the study device to the patient's face. Subjects will be lying down, and the prototypes will be administered upside down. During applications, subjects will wear diving goggles protecting the eyes from cryogenic gas. | Device | Condition 2 : prototypes (816-v1 301) to (816-v1 355) 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 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 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 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, 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 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 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) which allows realizing high resolution skin pictures. The capture will be taken on the previously selected lentigo and a spotless area.
Change from baseline spots color
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
L'OREAL Color-Chart is a visual mode of evaluation chart which includes 4 items : * Color of lentigo spot * Lightness of lentigo spot * Color of spotless area * Lightness of spotless area The items color of lentigo spot and color of spotless area are using a scale redder to yellower in 7 points (G to M). The items lightness of lentigo spot and lightness of spotless are using a scale lighter to darker in 15 points (5 to 19)
Change from baseline lentigines global improvement scale (LGIS) score
Time frame: Day 49 and Day 84
Lentigines Global Improvement Scale (LGIS) score will be used to assess the spots visibility This is a 7-point scale : * Completely clear - 0 - : No evidence of hyperpigmentation 100% improvement * Almost clear - 1 - : Very significant clearance (about 90%); only minor evidence of hyperpigmentation remains * Marked improvement - 2 - : Significant improvement (about 75%); score evidence of hyperpigmentation remains * Moderate improvement - 3 - : intermediate between marked and slight improvement; about 50% improvement in the appearance of hyperpigmentation * Slight improvement - 4 - : some improvement (about 25%); however significant evidence of hyperpigmentation remains * No change - 5 - : Hyperpigmentation has not changed since baseline * Worse - 6 - : Worse (hyperpigmentation is worse that at baseline)
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 3 Nov 2023.
- Individual participant dataSharing planned: No
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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.
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 (816-v1 301) to (816-v1 355) every week and Prototypes (816-v1 301) to (816-v1 355) every two weeks in people with Lentigo Solar and Senile Lentigo, 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 3 Nov 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 56, Day 70, Day 84 and Day 0 + 6 months). The study lists 8 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 3 Nov 2023.