Dataset Information

Efficacy and Safety of Three Cryotherapy Devices for Wart Treatment: A Randomized, Controlled, Investigator-Blinded, Comparative Study.

ABSTRACT: INTRODUCTION:Cutaneous warts are common skin lesions, caused by human papillomavirus. For years, liquid nitrogen is the cryogen of choice for wart treatment. Alternatively, several cryogenic devices for home treatment are commercially available. The present trial assessed efficacy and safety of a novel nitrous oxide-based cryogenic device for home use (EndWarts Freeze® in Europe, Compound W® Nitro-Freeze in the USA). METHODS:This investigator-blinded, controlled, randomized study compared the nitrous oxide device (test product) with a dimethylether propane-based product (Wartner®; comparator 1). Subjects with common or plantar warts (50/50 ratio) were randomized into two groups (n = 58, test product; n = 40, comparator 1). Sequentially, an extra treatment arm (n = 40) was added to compare with a dimethylether-based product with metal nib (Wortie®; comparator 2). Main objective implied comparison of the percentage cured subjects after one to maximum three treatments. Efficacy and safety was evaluated by a blinded investigator. RESULTS:After a maximum of three applications, a significantly (p = 0.001) higher cure rate of 70.7% (Intention-to-Treat analysis) was observed with test product versus 46.2% (comparator 1) and 47.5% (comparator 2). Almost three times more subjects were cured after 1 test product application (29.3%), versus comparator 1 (10.4%) and comparator 2 (12.5%). Reported side effects were transient and typical of cryotherapy. All treatments were well-tolerated. CONCLUSION:The superior cure rates for the test product versus two comparators can be explained by its design. Combination of nitrous oxide (cooling agent), the specific activation method (holding the liquid coolant in the cap), and skin-conforming polyurethane foam, results in higher cooling efficiency (- 80 °C) and more effective wart freezing. This trial demonstrated that the nitrous oxide device is a safe, user-friendly and effective wart treatment for home use, comparing favourably to dimethylether (propane) devices with higher freezing temperature, regardless of the applicator type. FUNDING:Oystershell Laboratories. TRIAL REGISTRATION:Clinicaltrials.gov identifier, NCT03129373.

SUBMITTER: Walczuk I

PROVIDER: S-EPMC6002322 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:BackgroundDue to increased resistance and safety concerns with insecticide-based pediculicides, there is growing demand for head lice treatments with a physical mode of action. Certain mineral oils kill lice by blocking spiracles or by disrupting the epicuticular wax layer. The present study was performed to evaluate efficacy and safety of a mineral oil-based shampoo.MethodsThis randomized, controlled, investigator-blinded, monocentric study (EudraCT registration no. 2014-002918-23) was performed from October 2014-June 2015 in Germany. A mineral oil shampoo (Mosquito® Med Läuse Shampoo 10 in Germany, Paranix or Silcap shampoo elsewhere), registered as medical device, was compared to a conventional, locally reimbursed, pyrethroid-based pediculicide (Goldgeist® Forte solution). In total, 107 patients (>1 year) with confirmed head lice infestation were included (test arm: n = 53; control arm: n = 54). All subjects received two applications of either test or control product at day 0 and day 7, according to the instructions for use. Efficacy and safety was evaluated directly, 1h and 24h after first application, before and after second treatment, and at day 10. The main objective was demonstrating a cure rate for the test product, being superior to 70% at day 10.ResultsCure rates at day 10 (corrected for re-infestation) for the test product (96.1%) and control (94%) significantly exceeded the pre-defined target (70%) (p < 0.001, 2-sided, 1-sample, chi-square test) with confirmed non-inferiority for the test product. Over all visits, cure rates were consistently higher for the test product, whereas more initially-cured subjects remained lice-free until end of study (78%; control: 60%). Both products were safe and well tolerated, offering good esthetical effects.ConclusionThis study showed that substance-based medical devices (including the tested mineral oil shampoo) can be safe and effective alternatives for insecticide-based pediculicides, with less risk for development of resistance because of the physical mode of action.Trial registrationGerman Clinical Trials Register (DRKS) DRKS00009753 and EudraCT database 2014-002918-23.

Project description:IntroductionSilicones (e.g., dimethicone) are effective and safe alternatives to insecticides for the treatment of head lice. However, silicones are lipophilic substances and do not only leave the hair greasy but they are also difficult to wash out. We have evaluated the efficacy and safety of a potential solution to this problem: an aqueous dispersion of a novel silylated polyol that has the same mode of action as dimethicone (suffocation) without its negative impact on hair characteristics.MethodsThis was a randomized, controlled, investigator-blinded, bicentric study that was conducted at two locations in the state of Florida (USA) to compare the test product (medical device) to a pyrethrum-based pediculicide that is a first-line, prescription-free treatment against head lice in the USA. The subjects (n = 70) were randomly divided into two groups of 35 persons (test product group and reference product group), with each participant receiving two applications (day 0 and 7) of the product to be tested, according to the instructions for use. Efficacy and safety was evaluated at distinct time points. The primary objective was to establish a cure rate for the test product that was better than 70% at study end (day 10). Esthetic effects of the test product versus dimethicone were evaluated in a blinded, cross-over consumer study (n = 100).ResultsAt study end, the cure rate (corrected for re-infestation) of 88.2% with the test product significantly surpassed the pre-defined target of 70%, and thus the superiority of the test product versus the reference product was confirmed. The number of subjects cured (free of head lice) after the first treatment was remarkably higher with the test product than with the reference product (57.1 vs. 2.9%, respectively). Both products were safe and well tolerated and both showed beneficial esthetical effects. The consumer test demonstrated that the test product had better washing-out properties than dimethicone, as reflected by a significantly lower average rinsing time and number of washings required to restore the visual aspect of the hair, especially in terms of greasiness.ConclusionAqueous dispersions of silylated polyols are a promising new class of pediculicides that combine high cure rates with optimal user convenience (short treatment period, easy wash-out with positive effect on hair quality).Trial registrationClinicalTrials.gov identifier, NCT03617926.FundingOystershell Laboratories.

Project description:BackgroundAndrogenetic alopecia (AGA) is the most common hair loss disorder seen in men. It can have an early onset but has also been associated with ageing and senescence. It often induces pronounced psychological impact. ALRV5XR, a new hair loss treatment herein evaluated, was designed to target multiple molecular pathways involved in hair growth and hair follicle stem cell biology. The main objectives of the study were the assessment of safety and efficacy profiles of ALRV5XR in men.MethodsThis 24-week, parallel randomised, placebo-controlled, double-blinded clinical trial was performed in a USA community clinic. Healthy men (age 22-65) with AGA and belonging to the Hamilton-Norwood (HN) classification I-VII and Fitzpatrick skin type (FST) I-VI, were randomly allocated in a 1:1 ratio into ALRV5XR or placebo treatment groups. Dermatologist assessment, phototrichograms, and blood samples were obtained in a blinded fashion at baseline, 12 and 24 weeks. Subjects were given a masked treatment consisting of oral capsules, shampoo, conditioner, and follicle serum, which was intended for daily use. Efficacy was assessed via absolute and per cent changes in terminal hair (TH) density, and response rates. The trial was registered with clinicaltrials.gov (NCT04450589) and is completed.FindingsForty-six subjects were enroled in the study, 23 allocated to the ALRV5XR treatment and 23 to the placebo group. Enrolment occurred from April 11 to October 23, 2018. Thirty-six subjects completed the trial (17 ALRV5XR, 19 placebo) and 11 subjects in each group were evaluable for TH outcomes. At 24 weeks, the absolute change in TH density improved by 21·0 THs/cm2 (95% CI: 9·2-32·8; p = 0·0014), and the relative density increased by 16·4% (95% CI: 7·4%-25·5%; p = 0·0012). The odds ratio for being a responder (≥ 0 change) was 87·4. TH density increased linearly and was not affected by HN, FST, ethnicity, age, or body mass index. All subjects in the ALRV5XR group responded to treatment while 81·8% of the placebo group decreased TH density. ALRV5XR induced statistically significant changes in both decrease in vellus hair (VH) density as well as in concomitant increase of the TH/VH ratio when compared to placebo. ALRV5XR was well tolerated, and no adverse events were observed.InterpretationALRV5XR treatment resulted in clinically significant TH regrowth in men with AGA. Furthermore, it appeared to reverse the characteristic hair miniaturisation seen in this condition. When compared to results of published trials of standard therapy, ALRV5XR showed a multi-fold increase both in efficacy and in response rates. In addition, the continuance of TH regrowth from 12 to 24 weeks suggests that the normal structure and function of non-productive telogen follicles is restored and that a normal hair phenotype may be attained by extended ALRV5XR treatment.FundingArbor Life Labs.

Dataset Information

Efficacy and Safety of Three Cryotherapy Devices for Wart Treatment: A Randomized, Controlled, Investigator-Blinded, Comparative Study.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets