Clinical trial NCT03157427: Clinical Evaluation of the Performance of a Difluoroethane-based Cyto-selective Cryotherapy to Treat Dark Spots on the Hand in 30 Volunteers.
Official title: Clinical Evaluation of the Performance of a Difluoroethane-based Cyto-selective Cryotherapy to Treat Dark Spots on the Hand in 30 Volunteers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Solar Lentigo
Keywords: Solar Lentigo, Cryotherapy, Difluoroethane
Lead sponsor: Cryobeauty
Sponsor class: INDUSTRY
Collaborators: name: CEISO
First posted: 2017-05-17
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: Inclusion Criteria:

* 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.

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.

Primary outcomes:
measure: Evaluation of CRYOBEAUTY MAINS's performance
timeFrame: 8 weeks
Secondary outcomes:
measure: Evaluation of solar lentigines numbers
timeFrame: 0 week : same-day following the CRYOBEAUTY MAINS treatment
measure: Evaluation of solar lentigines numbers
timeFrame: 4 weeks
measure: Evaluation of solar lentigines numbers
timeFrame: 8 weeks
measure: Evaluation of solar lentigines colors
timeFrame: 0 week : same-day following the CRYOBEAUTY MAINS treatment
measure: Evaluation of solar lentigines colors
timeFrame: 4 weeks
measure: Evaluation of solar lentigines colors
timeFrame: 8 weeks
measure: Assessment of pain intensity
timeFrame: 0 week : same-day following the CRYOBEAUTY MAINS treatment
measure: Complication and adverse events rate
timeFrame: 0 week : same-day following the CRYOBEAUTY MAINS treatment
measure: Complication and adverse events rate
timeFrame: 4 weeks
measure: Complication and adverse events rate
timeFrame: 8 weeks
measure: Assessment of ergonomic and device's readiness
timeFrame: 0 week : same-day following the CRYOBEAUTY MAINS treatment
measure: Assessment of volunteers feeling (QoL)
timeFrame: 0 week : same-day following the CRYOBEAUTY MAINS treatment
measure: Assessment of volunteers feeling (QoL)
timeFrame: 4 weeks
measure: Assessment of volunteers feeling (QoL)
timeFrame: 8 weeks
measure: Evaluation of CRYOBEAUTY MAINS's performance
timeFrame: 0 week : same-day following the CRYOBEAUTY MAINS treatment
measure: Evaluation of CRYOBEAUTY MAINS's performance
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Nice
country: France
facility: Cpcad Nice Hôpital Archet 2
Study officials:
affiliation: CPCAD Nice
name: Catherine Queille-Roussel, MD
role: PRINCIPAL_INVESTIGATOR
References: