Multicentric, Randomized, Evaluator Blinded Clinical Investigation for the Evaluation of Efficacy and Safety of Two Medical Devices for the Treatment of Onychomycosis

The goal of this clinical trial is to evaluate the effectiveness of FORTE, ACTIVE COVER LIGHT and Loceryl® in the treatment of onychomycosis based on the blinded evaluation of the percentage of healthy nail surface compared to baseline.

Start Date01 Mar 2024

Sponsor / Collaborator

Oystershell NV

[+1]

NCT05378477 / RecruitingNot Applicable

Randomized, Controlled, Assessor-Blinded, Comparative Study to Evaluate Safety & Efficacy of a New Suffocation Product vs an Oligodecene-based Suffocation Product, 1% Permethrin & a Fatty Acids-based Product in Subjects With Head Lice.

The present study is set-up to compare in vivo clinical performance and safety of the test product (X92001752) versus 3 other pediculicides (2 medical devices and 1 conventional pesticide).

Start Date17 Jan 2022

Sponsor / Collaborator

Oystershell NV

NCT04961684 / CompletedNot Applicable

Clinical Evaluation of Efficacy and Safety of a Medical Device for the Treatment of Toenail Onychomycosis

The efficacy and safety of Solver Pen (prototype number X92001704) is evaluated in this randomized, open label, controlled, investigator-blinded, comparative clinical trial in 76 patients. Subjects are treated with either the test medical device (Solver Pen) or the comparator (Loceryl, 5% amorolfine), respectively, for a period of 90 days. The primary objective of the investigation is the increase of percentage of healthy surface on the great toenail at study end versus baseline, as evaluated by a blinded investigator. Patients are followed up for a period of 90 days, with visits at D0 (baseline), D30, D60 and D90, respectively.

Start Date10 Feb 2020

Sponsor / Collaborator

Oystershell NV

100 Clinical Results associated with Oystershell NV

0 Patents (Medical) associated with Oystershell NV

Literatures (Medical) associated with Oystershell NV

01 Oct 2020·Dermatology and TherapyQ4 · MEDICINE

Evaluation of BepanGel Hydrogel Efficacy and Tolerability Using an Abrasive Wound Model in a Within-Person, Single-Center, Randomized, Investigator-Blind Clinical Investigation

Q4 · MEDICINE

ArticleOA

Author: Huisman, Maarten T ; Williams, Ragna ; de Salvo, Raffaella ; Trapp, Sonja ; Delcour, Lucie ; Rossel, Bart ; Zhang, Lei ; Wigger-Alberti, Walter

INTRODUCTIONOver the last few years, it has been demonstrated that a moist environment enhances the healing process and reduces scar formation of wounds. Such moist conditions can be created and maintained using hydrogels. The aim of this study was to evaluate wound healing, cooling efficacy, local tolerability, and cosmetic appearance of abrasive wounds treated with BepanGel wound care hydrogel.METHODSThis study was designed as a within-person, single-center, randomized, investigator-blind clinical investigation comparing a hydrogel-treated test field with an untreated test field in an abrasive wound model. In 33 subjects, two small superficial wounds were induced on the non-dominant forearms. Wounds were treated with BepanGel and covered with a standard semi-occlusive wound plaster or covered with a plaster alone for 11 consecutive days. Wound healing efficacy, cooling effect, and tolerability of the treatment were assessed over 12 investigational days. During follow-up at day 31, the cosmetic appearance of the wounds was evaluated.RESULTSOn day 12, the test field treated with BepanGel was completely healed in nearly all subjects (97.0%) in contrast with the test field treated with a plaster alone (18.2%, AUC_days 2-12 p < 0.0001) as assessed by a blinded investigator. Two-thirds of the unblinded subjects indicated an immediate cooling effect of the hydrogel (p = 0.0555). At the end of the investigation, the cosmetic appearance of the BepanGel-treated test fields scored superior to the fields treated with a plaster alone as evaluated by a blinded investigator (p = 0.0005) and the unblinded subjects (p = 0.0078). The hydrogel was generally well tolerated and no signs of infection or adverse events (AEs) related to the treatment were observed.CONCLUSIONThis evaluation shows that treatment of superficial cutaneous wounds with BepanGel results in improved wound healing as demonstrated by faster wound closure and a considerably better cosmetic appearance, while providing immediate cooling.TRIAL REGISTRATION NUMBEREUDAMED-No.: CIV-19-09-029744.

01 Mar 2019·Dermatology and TherapyQ4 · MEDICINE

Efficacy and Safety of a Water-Based Head Lice Lotion: A Randomized, Controlled, Investigator-Blinded, Comparative, Bicentric Study

Q4 · MEDICINE

ArticleOA

Author: Rivera, Elisabeth ; Adriaens, Els ; Serrano, Lidia ; Eertmans, Frank ; Rossel, Bart

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.

01 Sep 2018·Dermatology and TherapyQ4 · MEDICINE

Daily Application of an Aqueous, Acidifying, Peelable Nail Polish versus Weekly Amorolfine for Topical Onychomycosis Treatment: A Prospective, Randomized, Blinded Trial

Q4 · MEDICINE

ArticleOA

Author: Adriaens, Els ; Doss, Nejib ; Rossel, Bart ; Eertmans, Frank

INTRODUCTIONOnychomycosis is a fungal nail infection, frequently caused by dermatophytes, which occurs in 2-14% of Western adults. The present study was set up to evaluate the efficacy and safety of a water-based, peelable nail polish (daily application), which acidifies the nail environment, versus a 5% amorolfine nail lacquer (weekly application) for topical treatment of mild-to-moderate onychomycosis.METHODSOne hundred two adults were randomized in this open, prospective, blinded trial. Clinical efficacy was evaluated at baseline and days 30, 60, 120, and 180, respectively. All patients underwent microbiological testing (at baseline and study end). The primary objective of this trial was the change in the percentage of healthy nail surface at day 180.RESULTSThe percentage of healthy surface between baseline and day 180 increased with 11.8% in the test product group and 13.2% in the amorolfine group, which were statistically comparable. Other onychomycosis-related parameters (dystrophy, discolouration, thickening, and healthy aspect, respectively) showed significant (p < 0.05) improvement after 180 days (versus baseline) with both treatments. Clinical performance was further confirmed by the frequency of patients showing onychomycosis improvement or success at the end of the study: 96.0% (test product) versus 79.6% (amorolfine). Microbiological results and improved quality of life confirmed clinical performance. Both treatments were well tolerated and appreciated for their properties and efficacy.CONCLUSIONThe present trial confirmed the clinical performance of daily acidification of the nail, as reflected by (1) a comparable increase of percentage of healthy nail surface following treatment with the test product versus amorolfine, (2) the overall improvement of other onychomycosis-related parameters, (3) user convenience, and (4) absence of side effects. These data indicate that daily application of an aqueous, acetic acid-based, peelable solution can be a convenient, safe, and equally effective alternative for the topical management of onychomycosis.TRIAL REGISTRATIONClinicalTrials.gov identifier; NCT03382717 FUNDING: Oystershell Laboratories.

100 Deals associated with Oystershell NV

100 Translational Medicine associated with Oystershell NV

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