An interventional study of CRYOBEAUTY MAINS ET DECOLLETE and Liquid nitrogen 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 2018-01-04.
Sponsored by Cryobeauty · Not applicable, Interventional, and Treatment
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:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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.
Device: CRYOBEAUTY MAINS ET DECOLLETE
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.
Device: Liquid nitrogen
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.
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.
Also known as: Azote médical liquide
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: 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)
Time frame: 8 weeks
Performance assessment of CRYOBEAUTY HANDS AND DECOLLETE on the spots of the neckline.
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)
Time frame: 8 weeks
Evolution of spot's colour
Colours assessment: by using Mexameter® MX 18
Time frame: 0 weeks
Evolution of spot's colour
Colours assessment: by using Mexameter® MX 18
Time frame: 4 weeks
Evolution of spot's colour
Colours assessment: by using Mexameter® MX 18
Time frame: 8 weeks
Pain assessment
VAS
Time frame: 0 weeks
Incidence of Treatment-Emergent Adverse Events
Adverse events \[Safety and Tolerability\]
Time frame: 4 weeks
Incidence of Treatment-Emergent Adverse Events
Adverse events \[Safety and Tolerability\]
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 weeks
Assessment of volunteers feeling (QoL)
MelasQoL (Melasma. Quality of Life Scale)
Time frame: 0 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Oct 2017 to primary completion in Dec 2017, 1 month.
Of 11 interventional studies with no phase under Lentigo, half reached primary completion within 2 months of starting (the median); a quarter within 1 and three quarters within 13. This study's 1 month is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.