Solar Lentigo
Conditions
Keywords
Solar Lentigo, Cryotherapy, Difluoroethane
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).
Interventions
DEVICECRYOBEAUTY MAINS
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)
Sponsors
CEISO
Cryobeauty
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of CRYOBEAUTY MAINS's performance | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of solar lentigines colors | 0 week : same-day following the CRYOBEAUTY MAINS treatment | Colors assessment: by using Mexameter® MX 18 |
| Assessment of pain intensity | 0 week : same-day following the CRYOBEAUTY MAINS treatment | VAS |
| Complication and adverse events rate | 0 week : same-day following the CRYOBEAUTY MAINS treatment | Any complications or adverse events related or not to the treatment will be collected and evaluated. |
| Evaluation of solar lentigines numbers | 0 week : same-day following the CRYOBEAUTY MAINS treatment | Counting by enumeration of spots |
| Assessment of volunteers feeling (QoL) | 0 week : same-day following the CRYOBEAUTY MAINS treatment | MelasQoL (Melasma. Quality of Life Scale) |
| Evaluation of CRYOBEAUTY MAINS's performance | 0 week : same-day following the CRYOBEAUTY MAINS treatment | 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) |
| Assessment of ergonomic and device's readiness | 0 week : same-day following the CRYOBEAUTY MAINS treatment | Ergonomic and device's readiness questionnaire : 6 QCM questions are given to the participants |
Countries
France
Outcome results
None listed