Solar LentigoCBTNCT03157427

Clinical Evaluation of the Performance of a Difluoroethane-based Cyto-selective Cryotherapy to Treat Dark Spots on the Hand in 30 Volunteers.

A study testing CRYOBEAUTY MAINS in people with Solar Lentigo, run by Cryobeauty at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study evaluates the performance of "CRYOBEAUTY MAINS", a Cyto-selective Cryotherapy based on Difluoroethane as a treatment of Solar Lentigines in 30 volunteers. Only one application of "CRYOBEAUTY MAINS" in one hand (right or left hand according to the randomization code). 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
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: 21 Jun 2017to 12 Sep 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
Subjects having brown spots (solar lentigo) on both hands, diameter ≤ 6 mm (at least 1 spot per hand).
Accepting not to expose themselves to the sun (or artificial UV) during the study.
Affiliated to a health insurance scheme in accordance with the French law on research involving the human subjects
Informed, having undergone a general medical examination attesting to his / her ability to participate in the study.
Having given informed written consent for their participation in the study.

Show all 22Show fewer

Non inclusion Criteria:
Having carried out aesthetic care (exfoliants, scrubs or self-tanning, manicure, hand care, UV ...) in the month prior to the start of the study, on the hands.
Having applied a depigmenting product in the month prior to the start of the study, on the hands.
Having carried out aesthetic care at a dermatologist (laser, IPL, peeling, depigmenting creams, cryotherapy ...), on the hands, during the last 6 months.
Presenting dermatosis, autoimmune disease, systemic, chronic or acute illness, or any other condition that may interfere with the treatment or influence the results of the study (diabetic, circulatory, cold allergic, Raynaud's syndrome ...)
Any general or local treatment (dermocorticoids, corticosteroids, diuretics, etc.) likely to interfere with the evaluation of the parameter studied.
Participating in another study or being in an exclusion period from a previous study
Being unable to comply to the protocole.
Having Received over 4,500 euros compensation for his / her participation in clinical trials in the previous 12 months, including participation in this study.
Vulnerable: being unable to give or refuse consent.
Protected by the law (guardianship, curatorship, safeguard of justice ...).
Unable to write or read in French.
Can not be contacted by telephone.
For female subjects:
Pregnant woman (or wanting to be pregnant during the study) or during breastfeeding.
Female not willing to use contraceptives.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

France1 site

Cpcad Nice Hôpital Archet 2
Nice, 06200

Other trials in France

About this study

Conditions: Solar Lentigo
Being tested: CRYOBEAUTY MAINS
Keywords: Solar Lentigo, Cryotherapy, Difluoroethane

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CRYOBEAUTY MAINSDevice
CYOBEAUTY MAINS diffuses Difluoroethane gas to the skin. The administration of the cryogenic gas is temperature controlled, accurate and contactless (by means of a spray nozzle), in small quantity (<1g) and during a predetermined short duration (3 seconds)

Study groups in NCT03157427
Study group	Role	What they receive
CRYOBEAUTY MAINS	Experimental	Cryotherapy medical device designed to treat solar lentigo on the randomized hand. Receives: Device: CRYOBEAUTY MAINS
Control	No intervention	The non randomized hand is not teated.

What is being measured

The primary outcome is the main question the study is designed to answer.

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 evidence 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)
Measured: 8 weeks

Secondary outcomes (16)

Evaluation of solar lentigines numbers
Counting by enumeration of spots
Measured: 0 week : same-day following the CRYOBEAUTY MAINS treatment
Evaluation of solar lentigines numbers
Counting by enumeration of spots
Measured: 4 weeks
Evaluation of solar lentigines numbers
Counting by enumeration of spots
Measured: 8 weeks
Evaluation of solar lentigines colors
Colors assessment: by using Mexameter® MX 18
Measured: 0 week : same-day following the CRYOBEAUTY MAINS treatment
Evaluation of solar lentigines colors
Colors assessment: by using Mexameter® MX 18
Measured: 4 weeks
Evaluation of solar lentigines colors
Colors assessment: by using Mexameter® MX 18
Measured: 8 weeks
Assessment of pain intensity
VAS
Measured: 0 week : same-day following the CRYOBEAUTY MAINS treatment
Complication and adverse events rate
Any complications or adverse events related or not to the treatment will be collected and evaluated.
Measured: 0 week : same-day following the CRYOBEAUTY MAINS treatment
Complication and adverse events rate
Any complications or adverse events related or not to the treatment will be collected and evaluated.
Measured: 4 weeks
Complication and adverse events rate
Any complications or adverse events related or not to the treatment will be collected and evaluated.
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 week : same-day following the CRYOBEAUTY MAINS treatment
Assessment of volunteers feeling (QoL)
MelasQoL (Melasma. Quality of Life Scale)
Measured: 0 week : same-day following the CRYOBEAUTY MAINS treatment
Assessment of volunteers feeling (QoL)
MelasQoL (Melasma. Quality of Life Scale)
Measured: 4 weeks
Assessment of volunteers feeling (QoL)
MelasQoL (Melasma. Quality of Life Scale)
Measured: 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 evidence 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)
Measured: 0 week : same-day following the CRYOBEAUTY MAINS treatment
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 evidence 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)
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Jun 201712 Sep 2017

First posted17 May 2017
Study start21 Jun 2017
Primary completion12 Sep 2017
Study completion12 Sep 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
Model description: Patients will be treated on the randomized hand, the other hand is the comparator/control. Comparison between the treated hand and the control hand will be performed.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03157427
Sponsor's protocol ID: 2017-A00068-45
Acronym: CBT
Status last verified: Sep 2017
First submitted: 3 May 2017
Last updated: 12 Sep 2017
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
A Clinical Study to Evaluate the Efficacy in Improving Dark Spots After 8 Weeks of Use of Facial Sunscreens in Adult Participants
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

All Solar Lentigo trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of the Performance of a Difluoroethane-based Cyto-selective Cryotherapy to Treat Dark Spots on the Hand in 30 Volunteers.
ClinicalTrials.gov ID: NCT03157427
Acronym / sponsor ID: CBT / 2017-A00068-45
Conditions: Solar Lentigo
Keywords: Solar Lentigo, Cryotherapy, Difluoroethane
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: CryobeautyIndustry (pharma, biotech, devices)
Collaborators: CEISO
Study start: 21 Jun 2017 (actual)
Primary completion: 12 Sep 2017 (actual)
Study completion: 12 Sep 2017 (actual)
First posted: 17 May 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: Patients will be treated on the randomized hand, the other hand is the comparator/control. Comparison between the treated hand and the control hand will be performed.

Arm	Type	Receives
CRYOBEAUTY MAINS	Experimental	Device: CRYOBEAUTY MAINSCryotherapy medical device designed to treat solar lentigo on the randomized hand.
Control	No intervention	–The non randomized hand is not teated.

Who may qualify

Ages: 30 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (22 listed)

Phototype II to IV
Subjects having brown spots (solar lentigo) on both hands, diameter ≤ 6 mm (at least 1 spot per hand).
Accepting not to expose themselves to the sun (or artificial UV) during the study.
Affiliated to a health insurance scheme in accordance with the French law on research involving the human subjects
Informed, having undergone a general medical examination attesting to his / her ability to participate in the study.

Key exclusion criteria (0 listed)

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 MAINSCYOBEAUTY MAINS diffuses Difluoroethane gas to the skin. The administration of the cryogenic gas is temperature controlled, accurate and contactless (by means of a spray nozzle), in small quantity (<1g) and during a predetermined short duration (3 seconds)	Device	CRYOBEAUTY MAINS

Primary outcome

Evaluation of CRYOBEAUTY MAINS's performance
Time frame: 8 weeks
Hexsel scoring: 1. > Very significant clearance (about 90%); only minor evidence of hyper pigmentation remains 2. > Significant improvement (about 75%); some evidence 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)

16 secondary outcomes

Evaluation of solar lentigines numbers
Time frame: 0 week : same-day following the CRYOBEAUTY MAINS treatment
Evaluation of solar lentigines numbers
Time frame: 4 weeks
Evaluation of solar lentigines numbers
Time frame: 8 weeks
Evaluation of solar lentigines colors
Time frame: 0 week : same-day following the CRYOBEAUTY MAINS treatment
Evaluation of solar lentigines colors
Time frame: 4 weeks
Evaluation of solar lentigines colors
Time frame: 8 weeks
Assessment of pain intensity
Time frame: 0 week : same-day following the CRYOBEAUTY MAINS treatment
Complication and adverse events rate
Time frame: 0 week : same-day following the CRYOBEAUTY MAINS treatment
Complication and adverse events rate
Time frame: 4 weeks
Complication and adverse events rate
Time frame: 8 weeks
Assessment of ergonomic and device's readiness
Time frame: 0 week : same-day following the CRYOBEAUTY MAINS treatment
Assessment of volunteers feeling (QoL)
Time frame: 0 week : same-day following the CRYOBEAUTY MAINS treatment
Assessment of volunteers feeling (QoL)
Time frame: 4 weeks
Assessment of volunteers feeling (QoL)
Time frame: 8 weeks
Evaluation of CRYOBEAUTY MAINS's performance
Time frame: 0 week : same-day following the CRYOBEAUTY MAINS treatment
Evaluation of CRYOBEAUTY MAINS's performance
Time frame: 4 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 12 Sep 2017.
Individual participant dataSharing planned: No

Related trials for Solar Lentigo

Recruiting
A Clinical Study to Evaluate the Efficacy in Improving Dark Spots After 8 Weeks of Use of Facial Sunscreens in Adult Participants
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.

Catherine Queille-Roussel, MD principal investigator

CPCAD Nice

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 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 22 inclusion and 0 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 12 Sep 2017. 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?

Evaluation of CRYOBEAUTY MAINS's performance (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03157427.

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 12 Sep 2017.