An interventional study of CRYOBEAUTY MAINS in Solar Lentigo, sponsored by Cryobeauty. Completed at 1 site in France. Open to participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-09-12.
Sponsored by Cryobeauty · Not applicable, Interventional, and Treatment
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).
28 studies on the registry are indexed under Lentigo; 2 are open to participants now.
This study's enrollment of 30 is close to the median of 30 across 25 interventional studies indexed under Lentigo.
Browse Lentigo studies →Cryobeauty is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Non inclusion Criteria:
For female subjects:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cryotherapy medical device designed to treat solar lentigo on the randomized hand.
Device: CRYOBEAUTY MAINS
The non randomized hand is not teated.
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)
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)
Time frame: 8 weeks
Evaluation of solar lentigines numbers
Counting by enumeration of spots
Time frame: 0 week : same-day following the CRYOBEAUTY MAINS treatment
Evaluation of solar lentigines numbers
Counting by enumeration of spots
Time frame: 4 weeks
Evaluation of solar lentigines numbers
Counting by enumeration of spots
Time frame: 8 weeks
Evaluation of solar lentigines colors
Colors assessment: by using Mexameter® MX 18
Time frame: 0 week : same-day following the CRYOBEAUTY MAINS treatment
Evaluation of solar lentigines colors
Colors assessment: by using Mexameter® MX 18
Time frame: 4 weeks
Evaluation of solar lentigines colors
Colors assessment: by using Mexameter® MX 18
Time frame: 8 weeks
Assessment of pain intensity
VAS
Time frame: 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.
Time frame: 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.
Time frame: 4 weeks
Complication and adverse events rate
Any complications or adverse events related or not to the treatment will be collected and evaluated.
Time frame: 8 weeks
Assessment of ergonomic and device's readiness
Ergonomic and device's readiness questionnaire : 6 QCM questions are given to the participants
Time frame: 0 week : same-day following the CRYOBEAUTY MAINS treatment
Assessment of volunteers feeling (QoL)
MelasQoL (Melasma. Quality of Life Scale)
Time frame: 0 week : same-day following the CRYOBEAUTY MAINS treatment
Assessment of volunteers feeling (QoL)
MelasQoL (Melasma. Quality of Life Scale)
Time frame: 4 weeks
Assessment of volunteers feeling (QoL)
MelasQoL (Melasma. Quality of Life Scale)
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 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)
Time frame: 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)
Time frame: 4 weeks
Plan to share: No
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This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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