Solar LentigoCBT-EC2NCT03225729
Assessment of CRYOBEAUTY MAINS ET DECOLLETE Versus Liquid Nitrogen Cryotherapy, in the Treatment of Solar Lentigines
A study testing CRYOBEAUTY MAINS ET DECOLLETE and Liquid nitrogen in people with Solar Lentigo, run by Cryobeauty at 1 site in France.
Trial summary
This study evaluates the performance of new technology "CRYOTHERAPY MAINS ET DECOLLETE" against a classic cryotherapy "Nitrogen Liquid " to treat solar lentigines. The hands and the neckline will be randomised, either left or right side and treated by two cryotherapy devices: 1. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Solar Lentigo
- What is being tested?
- CRYOBEAUTY MAINS ET DECOLLETE and Liquid nitrogen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 25 Oct 2017to 22 Dec 2017
- 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
- Phototype II to IV
- Presenting solar lentigos on both hands and neck, diameter ≤ 6mm
- Accepting not to expose the body to sunlight or artificial UV rays during the study
- Affiliate to a health insurance plan
- Having undergone a general clinical examination attesting to his / her ability to participate in the study
- Having given written consent
Who cannot join
- Having carried out aesthetic care (exfoliants, scrubs or self-tanning, manicure, hand care, UV ...) in the month before the start of the study, at the level of the hands and/or neckline.
- Having applied a depigmenting product in the month preceding the start of the study, at the level of the hands and/or neckline.
- Having carried out aesthetic care at a dermatologist (laser, IPL, peeling, depigmenting creams, cryotherapy ...), at the level of the hands and/or neckline, during the last six months
- Dermatosis, autoimmune disease (vitiligo), systemic, chronic or acute disease, or any other disease that may interfere with the treatment or influence the results of the study (people with diabetes, circulatory problems, cold allergies, With Raynaud's syndrome ...)
- Receiving general or local treatment (corticosteroids ...) likely to interfere with the evaluation of the studied parameters.
- Participating in another study or being in an exclusion period from a previous study
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- Being incapable of following the requirements of the protocol
- Person protected by law
- Unable to read and write French
- Pregnant woman or woman wishing to be pregnant during the study, or during breastfeeding period
- Women of childbearing age who do not have contraception
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Clinical Trial to Assess the Performance of a Cyto-selective Cryotherapye "CRYOBEAUTY MAINS ET DECOLLETE" Compared With Liquid Nitrogen Cryotherapy in the Treatment of Solar Lentigines in 30 Patients
This study evaluates the performance of new technology "CRYOTHERAPY MAINS ET DECOLLETE" against a classic cryotherapy "Nitrogen Liquid " to treat solar lentigines.
The hands and the neckline will be randomised, either left or right side and treated by two cryotherapy devices:
- CRYOTHERAPY MAINS ET DECOLLETE is the device under evaluation.
- Liquid nitrogen is a comparator device.
- Conditions
- Solar Lentigo
- Being tested
- CRYOBEAUTY MAINS ET DECOLLETE, Liquid nitrogen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRYOBEAUTY MAINS ET DECOLLETEDevice
The intervention lasts up to 6.5 s. The device will be applied on spots <6 mm which are previously selected by the investigator team.
Liquid nitrogenDevice
Also called Azote médical liquide
The intervention lasts up to 3 s. The liquid is stored in well-isolated recipients. Each patient has his recipient to avoid contamination. The investigator applies on spots <6 mm a small amount of nitrogen liquid.
| Study group | Role | What they receive |
|---|---|---|
| CRYOBEAUTY MAINS ET DECOLLETE | Experimental | CRYOBEAUTY MAINS ET DECOLLETE is a new technology conceived to treat solar lentigo.
One side left, or right of neckline and/or hands is attributed to this device according to randomization protocol. Receives: Device: CRYOBEAUTY MAINS ET DECOLLETE |
| Liquid nitrogen | Active comparator | Liquid nitrogen is a classic cryotherapy device. One side, either left or right of neckline and/or hands are attributed to this device according to randomization protocol. Receives: Device: Liquid nitrogen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance assessment of new cryotherapy device "CRYOTHERAPY MAIN ET DECOLLETE" to treat solar lentigo spots on the hands.
Evaluation of CRYOBEAUTY MAINS's performance
Hexsel scoring:
- > Very significant clearance (about 90%); only minor evidence of hyper pigmentation remains
- > Significant improvement (about 75%); some signs of hyper pigmentation remains
- > Intermediate between marked and slight improvement; about 50% improvement in the appearance of hyper pigmentation
- > Some improvement (about 25%); however, significant evidence of hyper pigmentation remains
- > Hyperpigmentation has not changed since baseline
- > Worse (hyperpigmentation is worse than at baseline)
Measured: 8 weeks
Secondary outcomes (9)
Performance assessment of CRYOBEAUTY HANDS AND DECOLLETE on the spots of the neckline.
Evaluation of CRYOBEAUTY MAINS's performance
Hexsel scoring:
- > Very significant clearance (about 90%); only minor evidence of hyper pigmentation remains
- > Significant improvement (about 75%); some signs of hyper pigmentation remains
- > Intermediate between marked and slight improvement; about 50% improvement in the appearance of hyper pigmentation
- > Some improvement (about 25%); however, significant evidence of hyper pigmentation remains
- > Hyperpigmentation has not changed since baseline
- > Worse (hyperpigmentation is worse than at baseline)
Measured: 8 weeks
Evolution of spot's colour
Colours assessment: by using Mexameter® MX 18
Measured: 0 weeks
Evolution of spot's colour
Colours assessment: by using Mexameter® MX 18
Measured: 4 weeks
Evolution of spot's colour
Colours assessment: by using Mexameter® MX 18
Measured: 8 weeks
Pain assessment
VAS
Measured: 0 weeks
Incidence of Treatment-Emergent Adverse Events
Adverse events [Safety and Tolerability]
Measured: 4 weeks
Incidence of Treatment-Emergent Adverse Events
Adverse events [Safety and Tolerability]
Measured: 8 weeks
Assessment of ergonomic and device's readiness
Ergonomic and device's readiness questionnaire: 6 QCM questions are given to the participants
Measured: 0 weeks
Assessment of volunteers feeling (QoL)
MelasQoL (Melasma. Quality of Life Scale)
Measured: 0 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start25 Oct 2017
- Primary completion22 Dec 2017
- Study completion22 Dec 2017
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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cryobeauty
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CEISO
- Responsible party
- Sponsor
- Investigators
- Catherine Queille-Roussel, MD, Principal investigator, Centre de Pharmacologie Clinique Applique a la Dermatologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03225729
- Sponsor's protocol ID
- 2017-A02179-44
- Acronym
- CBT-EC2
- Status last verified
- Jan 2018
- First submitted
- 20 Jul 2017
- Last updated
- 4 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Trial to Assess the Performance of a Cyto-selective Cryotherapye "CRYOBEAUTY MAINS ET DECOLLETE" Compared With Liquid Nitrogen Cryotherapy in the Treatment of Solar Lentigines in 30 Patients
- ClinicalTrials.gov ID
- NCT03225729
- Acronym / sponsor ID
- CBT-EC2 / 2017-A02179-44
- Conditions
- Solar Lentigo
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- CryobeautyIndustry (pharma, biotech, devices)
- Collaborators
- CEISO
- Study start
- 25 Oct 2017 (actual)
- Primary completion
- 22 Dec 2017 (actual)
- Study completion
- 22 Dec 2017 (actual)
- First posted
- 21 Jul 2017 (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.
This study evaluates the performance of new technology "CRYOTHERAPY MAINS ET DECOLLETE" against a classic cryotherapy "Nitrogen Liquid " to treat solar lentigines.
The hands and the neckline will be randomised, either left or right side and treated by two cryotherapy devices:
- CRYOTHERAPY MAINS ET DECOLLETE is the device under evaluation.
- Liquid nitrogen is a comparator device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRYOBEAUTY MAINS ET DECOLLETE | Experimental | Device: CRYOBEAUTY MAINS ET DECOLLETECRYOBEAUTY MAINS ET DECOLLETE is a new technology conceived to treat solar lentigo. One side left, or right of neckline and/or hands is attributed to this device according to randomization protocol. |
| Liquid nitrogen | Active comparator | Device: Liquid nitrogenLiquid nitrogen is a classic cryotherapy device. One side, either left or right of neckline and/or hands are attributed to this device according to randomization protocol. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Phototype II to IV
- Presenting solar lentigos on both hands and neck, diameter ≤ 6mm
- Accepting not to expose the body to sunlight or artificial UV rays during the study
- Affiliate to a health insurance plan
- Having undergone a general clinical examination attesting to his / her ability to participate in the study
Key exclusion criteria (11 listed)
- Having carried out aesthetic care (exfoliants, scrubs or self-tanning, manicure, hand care, UV ...) in the month before the start of the study, at the level of the hands and/or neckline.
- Having applied a depigmenting product in the month preceding the start of the study, at the level of the hands and/or neckline.
- Having carried out aesthetic care at a dermatologist (laser, IPL, peeling, depigmenting creams, cryotherapy ...), at the level of the hands and/or neckline, during the last six months
- Dermatosis, autoimmune disease (vitiligo), systemic, chronic or acute disease, or any other disease that may interfere with the treatment or influence the results of the study (people with diabetes, circulatory problems, cold allergies, With Raynaud's syndrome ...)
- Receiving general or local treatment (corticosteroids ...) likely to interfere with the evaluation of the studied parameters.
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 |
|---|---|---|
| CRYOBEAUTY MAINS ET DECOLLETEThe intervention lasts up to 6.5 s. The device will be applied on spots <6 mm which are previously selected by the investigator team. | Device | CRYOBEAUTY MAINS ET DECOLLETE |
| Liquid nitrogenAlso: Azote médical liquideThe intervention lasts up to 3 s. The liquid is stored in well-isolated recipients. Each patient has his recipient to avoid contamination. The investigator applies on spots <6 mm a small amount of nitrogen liquid. | Device | Liquid nitrogen |
Primary outcome
Performance assessment of new cryotherapy device "CRYOTHERAPY MAIN ET DECOLLETE" to treat solar lentigo spots on the hands.
Time frame: 8 weeks
Evaluation of CRYOBEAUTY MAINS's performance Hexsel scoring: 1. > Very significant clearance (about 90%); only minor evidence of hyper pigmentation remains 2. > Significant improvement (about 75%); some signs of hyper pigmentation remains 3. > Intermediate between marked and slight improvement; about 50% improvement in the appearance of hyper pigmentation 4. > Some improvement (about 25%); however, significant evidence of hyper pigmentation remains 5. > Hyperpigmentation has not changed since baseline 6. > Worse (hyperpigmentation is worse than at baseline)
9 secondary outcomes
Performance assessment of CRYOBEAUTY HANDS AND DECOLLETE on the spots of the neckline.
Time frame: 8 weeks
Evolution of spot's colour
Time frame: 0 weeks
Evolution of spot's colour
Time frame: 4 weeks
Evolution of spot's colour
Time frame: 8 weeks
Pain assessment
Time frame: 0 weeks
Incidence of Treatment-Emergent Adverse Events
Time frame: 4 weeks
Incidence of Treatment-Emergent Adverse Events
Time frame: 8 weeks
Assessment of ergonomic and device's readiness
Time frame: 0 weeks
Assessment of volunteers feeling (QoL)
Time frame: 0 weeks
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 4 Jan 2018.
- Individual participant dataSharing planned: Undecided
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Solar Lentigo
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Queille-Roussel, MD principal investigator
Centre de Pharmacologie Clinique Applique a la Dermatologie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CRYOBEAUTY MAINS ET DECOLLETE and Liquid nitrogen in people with Solar Lentigo, run by Cryobeauty at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 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 4 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
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?
Performance assessment of new cryotherapy device "CRYOTHERAPY MAIN ET DECOLLETE" to treat solar lentigo spots on the hands. (time frame: 8 weeks). 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 4 Jan 2018.