Solar LentigoNCT05883657
Tolerance and Performance of Cyto-selective Difluoroethane-based Cryotherapy in the Treatment of Brown Spots (Solar and Senile Lentigines, Post-Inflammatory Hyperpigmentation)
A study testing Condition 1 : Prototypes (816-v1) every weeks and Condition 2 : Prototypes (816-v1) every two weeks in people with Solar Lentigo and Senile Lentigo, run by Cryonove Pharma at 1 site in South Africa.
Trial summary
CS5_7 study aim to evaluate the tolerance and to adjust the mode of administration of two conditions of cryotherapy treatment applied on the brown spots of the face and hands with 1 prototype (816-v1). A brown spot is defined as solar or senile lentigo and post-inflammatory hyperpigmentation (PIH). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solar Lentigo, Senile Lentigo, Post Inflammatory Hyperpigmentation
- What is being tested?
- Condition 1 : Prototypes (816-v1) every weeks and Condition 2 : Prototypes (816-v1) every two weeks
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSouth Africa
- Study dates
- 10 Jun 2023to 12 Dec 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female or male.
- Ages 18 to 75.
- Phototypes V and VI (according with Fitzpatrick scale), according to the spots' distribution table.
- Featuring brown spots ≥ 3 and ≤ 6 mm in diameter (on the face (and when possible, on the hands).
- 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 (only nails care acceptable), facials, UV ...) in the month before the start of the study, at the level of the face and/or hands.
- Having applied a depilatoring product in the month prior to the start of the study, on the face and/or hands.
- Having performed cosmetic treatments in a dermatologist (laser, Intense Pulsed Light (IPL), peeling, creams, cryotherapy ...), on the face and/or 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 on a period of exclusion from a previous study.
Show all 14Show fewer
- 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 english 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.
South Africa1 site
Photobiology Laboratory, Sefako Makgatho Health Sciences University
Pretoria, Gauteng, 0204
Beverley Summers, Pr
About this study
Official title: Evaluation of the Tolerance and Performance of Cyto-selective Difluoroethane-based Cryotherapy in the Treatment of Brown Spots (Solar and Senile Lentigines, Post-Inflammatory Hyperpigmentation)
CS5_7 study aim to evaluate the tolerance and to adjust the mode of administration of two conditions of cryotherapy treatment applied on the brown spots of the face and hands with 1 prototype (816-v1). A brown spot is defined as solar or senile lentigo and post-inflammatory hyperpigmentation (PIH).
The study will evaluate the following prototype :
- Prototypes from (816-v1 201) to (816-v1 290)
Read the detailed description
Rational :
Hyperpigmentation is a problem in all skin types. Safe depigmentation is a challenge. Cryotherapy with liquid nitrogen at -70 °C has been used in the treatment of solar skin lesions for many years but causes considerable damage.
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.
A solar/senile lentigo is a flat, well-circumscribed patch. It can be round, oval or irregular in shape. Colour varies from skin-coloured, tan to dark brown or black, and size varies from a few millimetres to several centimetres in diameter. They can be slightly scaly. 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 its research and development activities, the sponsor has selected a new sequence of a specific cryogenic spray which has been used effectively and safely for lentigos treatment in Fitzpatrick phototypes I to IV on the face, with benefit for the subjects without any adverse safety outcomes. There is therefore a need to test the devices for lentigo and PIH on darker skin phototypes (V and VI according to Fitzpatrick scale), which also encounter hyperpigmentation challenges.
In the study, the clinical evaluation of different criteria performed by a Dermatologist before and after treatment will lead to objectively assess the safety (outcomes) and efficacy (depigmenting) of concerned criteria.
Design:
The study performed is a proof of performance designed to be interventional, monocentric, randomized and double blinded.
Intervention :
1 prototype of devices is evaluated in 2 conditions. Each treatment corresponds to a combination of a specific sequence of a cryogenic spray and of a frequency of application
At least 80 spots will be randomized between the 2 conditions. Prototypes (816-v1 201) to (816-v1 290) will be applied on brown spots located on the face and/or the hands .
In condition 1, each spots will be treated 12 times by a defined prototype (always the same device on the same spot all along the study) and according to specific frequencies (every week).
In condition 2, each spots will be treated 6 times by a defined prototype (always the same device on the same spot all along the study) and according to specific frequencies (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. For the application on the hands, the hands will be placed flat on the table and the prototypes will be applied upside down.
The patient follow-up visits are from Day 0 to 6 months.
- Being tested
- Condition 1 : Prototypes (816-v1) every weeks, Condition 2 : Prototypes (816-v1) every two weeks
- Keywords
- Cryotherapy, Skin Disease, Hyperpigmentation
- 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.
Condition 1 : Prototypes (816-v1) every weeksDevice
Application on brown spots located on the face and/or the hand (12 treatments during the study). An operator previously trained by the dermatologist will apply the study device to the patient's face or/and hand. Subjects will be lying down, and the prototypes will be administered upside down for the applications on the face and sitting for the applications on the hands. For the application on the hands, the hands will be placed flat on the table and the prototypes will be applied upside down. During applications on the face, subjects will wear diving goggles protecting the eyes from cryogenic gas.
Condition 2 : Prototypes (816-v1) every two weeksDevice
Application on brown spots located on the face and/or the hand (6 treatments during the study). An operator previously trained by the dermatologist will apply the study device to the patient's face or/and hand. Subjects will be lying down, and the prototypes will be administered upside down for the applications on the face and sitting for the applications on the hands. For the application on the hands, the hands will be placed flat on the table and the prototypes will be applied upside down. During applications on the face, subjects will wear diving goggles protecting the eyes from cryogenic gas.
| Study group | Role | What they receive |
|---|---|---|
| Condition 1 : Prototypes (816-v1) every weeks | Experimental | Application on the brown spots of the face and the hands for the prototypes (816-v1) at D0, D7, D14, D21, D28, D35, D42, D49, D56, D63, D70 and D77. Receives: Device: Condition 1 : Prototypes (816-v1) every weeks |
| Condition 2 : Prototypes (816-v1) every two weeks | Experimental | Application on the brown spots of the face and the hands for the prototypes (816-v1) at D0, D14, D28, D42, D56 and D70. Receives: Device: Condition 2 : Prototypes (816-v1) 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 49, Day 56, Day 63, Day 70, Day 77, 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 49, Day 56, Day 63, Day 70, Day 77, 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 49, Day 56, Day 63, Day 70, Day 77, 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 63, Day 70, Day 77, 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
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 63, Day 70, Day 77, Day 84 and Day 0 + 6 months
Incidence of unexpected events
Unexpected events
Measured: Day 0, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 63, Day 70, Day 77, 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 posted1 Jun 2023
- Study start10 Jun 2023 (estimated)
- Primary completion12 Dec 2023 (estimated)
- Study completion12 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solar LentigoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cryonove Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dermatech, CEISO, Sefako Makgatho Health Sciences University
- Responsible party
- Sponsor
- Investigators
- Beverley Summers, Pr, Principal investigator, Photobiology Laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05883657
- Sponsor's protocol ID
- CS5_7
- Status last verified
- Apr 2023
- First submitted
- 22 May 2023
- Last updated
- 1 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 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Tolerance and Performance of Cyto-selective Difluoroethane-based Cryotherapy in the Treatment of Brown Spots (Solar and Senile Lentigines, Post-Inflammatory Hyperpigmentation)
- ClinicalTrials.gov ID
- NCT05883657
- Acronym / sponsor ID
- CS5_7
- Keywords
- Cryotherapy, Skin Disease, Hyperpigmentation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Cryonove PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Dermatech, CEISO, Sefako Makgatho Health Sciences University
- Study start
- 10 Jun 2023 (estimated)
- Primary completion
- 12 Dec 2023 (estimated)
- Study completion
- 12 Dec 2023 (estimated)
- First posted
- 1 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
CS5_7 study aim to evaluate the tolerance and to adjust the mode of administration of two conditions of cryotherapy treatment applied on the brown spots of the face and hands with 1 prototype (816-v1). A brown spot is defined as solar or senile lentigo and post-inflammatory hyperpigmentation (PIH).
The study will evaluate the following prototype :
- Prototypes from (816-v1 201) to (816-v1 290)
Detailed description
Rational :
Hyperpigmentation is a problem in all skin types. Safe depigmentation is a challenge. Cryotherapy with liquid nitrogen at -70 °C has been used in the treatment of solar skin lesions for many years but causes considerable damage.
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.
A solar/senile lentigo is a flat, well-circumscribed patch. It can be round, oval or irregular in shape. Colour varies from skin-coloured, tan to dark brown or black, and size varies from a few millimetres to several centimetres in diameter. They can be slightly scaly. 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 its research and development activities, the sponsor has selected a new sequence of a specific cryogenic spray which has been used effectively and safely for lentigos treatment in Fitzpatrick phototypes I to IV on the face, with benefit for the subjects without any adverse safety outcomes. There is therefore a need to test the devices for lentigo and PIH on darker skin phototypes (V and VI according to Fitzpatrick scale), which also encounter hyperpigmentation challenges.
In the study, the clinical evaluation of different criteria performed by a Dermatologist before and after treatment will lead to objectively assess the safety (outcomes) and efficacy (depigmenting) of concerned criteria.
Design:
The study performed is a proof of performance designed to be interventional, monocentric, randomized and double blinded.
Intervention :
1 prototype of devices is evaluated in 2 conditions. Each treatment corresponds to a combination of a specific sequence of a cryogenic spray and of a frequency of application
At least 80 spots will be randomized between the 2 conditions. Prototypes (816-v1 201) to (816-v1 290) will be applied on brown spots located on the face and/or the hands .
In condition 1, each spots will be treated 12 times by a defined prototype (always the same device on the same spot all along the study) and according to specific frequencies (every week).
In condition 2, each spots will be treated 6 times by a defined prototype (always the same device on the same spot all along the study) and according to specific frequencies (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. For the application on the hands, the hands will be placed flat on the table and the prototypes will be applied upside down.
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) every weeks | Experimental | Device: Condition 1 : Prototypes (816-v1) every weeksApplication on the brown spots of the face and the hands for the prototypes (816-v1) at D0, D7, D14, D21, D28, D35, D42, D49, D56, D63, D70 and D77. |
| Condition 2 : Prototypes (816-v1) every two weeks | Experimental | Device: Condition 2 : Prototypes (816-v1) every two weeksApplication on the brown spots of the face and the hands for the prototypes (816-v1) at D0, D14, D28, D42, D56 and D70. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female or male.
- Ages 18 to 75.
- Phototypes V and VI (according with Fitzpatrick scale), according to the spots' distribution table.
- Featuring brown spots ≥ 3 and ≤ 6 mm in diameter (on the face (and when possible, on the hands).
- 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 (only nails care acceptable), facials, UV ...) in the month before the start of the study, at the level of the face and/or hands.
- Having applied a depilatoring product in the month prior to the start of the study, on the face and/or hands.
- Having performed cosmetic treatments in a dermatologist (laser, Intense Pulsed Light (IPL), peeling, creams, cryotherapy ...), on the face and/or 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 |
|---|---|---|
| Condition 1 : Prototypes (816-v1) every weeksApplication on brown spots located on the face and/or the hand (12 treatments during the study). An operator previously trained by the dermatologist will apply the study device to the patient's face or/and hand. Subjects will be lying down, and the prototypes will be administered upside down for the applications on the face and sitting for the applications on the hands. For the application on the hands, the hands will be placed flat on the table and the prototypes will be applied upside down. During applications on the face, subjects will wear diving goggles protecting the eyes from cryogenic gas. | Device | Condition 1 : Prototypes (816-v1) every weeks |
| Condition 2 : Prototypes (816-v1) every two weeksApplication on brown spots located on the face and/or the hand (6 treatments during the study). An operator previously trained by the dermatologist will apply the study device to the patient's face or/and hand. Subjects will be lying down, and the prototypes will be administered upside down for the applications on the face and sitting for the applications on the hands. For the application on the hands, the hands will be placed flat on the table and the prototypes will be applied upside down. During applications on the face, subjects will wear diving goggles protecting the eyes from cryogenic gas. | Device | Condition 2 : Prototypes (816-v1) 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 63, Day 70, Day 77, 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 63, Day 70, Day 77, 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 63, Day 70, Day 77, 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 63, Day 70, Day 77, 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. 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 63, Day 70, Day 77, 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.
Incidence of unexpected events
Time frame: Day 0, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 63, Day 70, Day 77, Day 84 and Day 0 + 6 months
Unexpected events
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
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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.
Beverley Summers, Pr principal investigator
Photobiology Laboratory
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Condition 1 : Prototypes (816-v1) every weeks and Condition 2 : Prototypes (816-v1) every two weeks in people with Solar Lentigo and Senile Lentigo, run by Cryonove Pharma at 1 site in South Africa.
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: status not confirmed, as of the sponsor's last update on 1 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 South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-Christophe ANTON (+33 6 80 23 61 13, jc.anton@cryonovepharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline skin hyperpigmentation (time frame: Day 0, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 63, Day 70, Day 77, Day 84 and Day 0 + 6 months). 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 1 Jun 2023.