The results of this study provide evidence that use of Super Poligrip® denture adhesives can enhance aspects of performance of complete well-fitting dentures as well as provide increased comfort, confidence, and satisfaction with dentures.
PurposeThese studies describe the testing of a novel, daily-use lip cream designed for individuals with lips prone to recurrent herpes labialis (RHL) that protects against environmental triggers.Subjects and methodsIn vitro occlusive and in vitro and in vivo photoprotection analyses, a characterization of normal vs dry lips, and a randomized, evaluator-blinded, clinical trial that assessed the lip cream in healthy subjects with dry lips were conducted. In the clinical trial, subjects applied the lip cream or were untreated and evaluated using transepidermal water loss (TEWL), corneometry, visual assessments of lip dryness, expert photographic evaluations, and subject-rated outcomes.ResultsThe lip cream’s in vitro water vapor transmission rate (84.1 g/(m2 h)) indicated moderate occlusivity. The lip cream, but not placebo or control (water), reduced ultraviolet A (UVA)- and UVB-induced DNA damage, and tumor necrosis factor-α (EpiDermFT) and pros-taglandin E2 release (EpiDermFT and EpiGingival™). The lip cream’s in vivo sun protection factor (SPF) was 12.2 (lower confidence limit, 11.3) and SPF/UVA protection factor ratio was 0.9. The characterization of dry vs normal lips identified differences in moisturization. In the clinical trial, the lip cream significantly decreased TEWL (difference: −7.19 [95% CI: −11.41, −2.98]; P<0.01), increased corneometry (difference: 4.62 [95% CI: 1.05, 8.19]; P<0.05), and reduced visual dryness (difference: −1.48 [95% CI: 2.24, −0.71]; P<0.001) compared to untreated subjects. Significant benefits were also observed on expert photographic assessments of scaling (difference: −0.89 [95% CI: −1.75, −0.03]; P< 0.05), cupping (difference: −1.50 [95% CI: −2.30, −0.70]; P<0.001), and healthy appearance (difference: −1.44 [95% CI: −2.29, −0.58]; P<0.01); differences in overall healthy appearance were not significant (P=0.51). Subject-rated assessments indicated improvements in cracking, dryness, and flaking in the lip cream group but worsening in untreated subjects.ConclusionThese studies indicate that this novel, daily-use lip cream protects against UV radiation, drying, and chapping, which are established environmental RHL triggers.
BackgroundExternal nasal dilator strips are used as nonpharmacological therapy to reduce snoring and daytime sleepiness. In a product improvement initiative, a marketed strip (BRNS) and 2 prototype nasal strips were evaluated.ObjectiveTo compare the nasal patency and multiple-use dermal tolerability of the BRNS and prototype nasal strips using both objective and subject-reported outcome measures.MethodsTwo studies were conducted separately in healthy volunteers ≥18 years of age. A single-day nasal patency randomized crossover study assessed minimal cross-sectional area (MCA; second restriction) and nasal volume (using acoustic rhinometry); nasal inspiratory flow and resistance (using posterior rhinomanometry); and subject-reported evaluations of the BRNS compared with the butterfly strip and teardrop strip prototypes. A single-center, randomized, controlled, parallel-group, evaluator-blinded study assessed dermal tolerability of the BRNS and the butterfly strip over 7 consecutive nights of use, using the Dermal Response Scale (DRS) and subject-reported comfort and ease of removal.ResultsIn the Patency study (N = 50), all 3 strips demonstrated significant improvement from baseline in MCA, nasal volume, and nasal flow parameters (resistance and peak flow). The prototype strips demonstrated significantly more improvement in nasal volume than the BRNS, and the butterfly strip showed significantly more improvement in MCA than the BRNS; all strips were similar with respect to nasal flow and subject-reported nasal breathing outcomes. In the Dermal Tolerability study (N = 82), all subjects scored 0 (no evidence of irritation) on the DRS at all 7 morning assessments; the BRNS was numerically, but not significantly, superior to the butterfly strip on subject-reported outcomes.ConclusionThe Patency study demonstrated significant improvement from baseline in nasal dimensions and flow for all 3 evaluated strips; between-strip differences were confined to nasal dimensions. Both the BRNS and butterfly strip were generally well tolerated, with no evidence of dermal response over 7 consecutive nights of use.ClinicalTrials.gov identifiers: NCT01105949 and NCT01495494
Behaviorally provoked nicotine craving can be significantly and safely reduced in heavy/high-dependency smokers with 4-mg nicotine mini lozenges.
IntroductionTwo multicenter, double-blind, randomized controlled trials assessed the effect of Breathe Right Nasal Strips (BRNS) on sleep-related quality of life in otherwise healthy subjects with chronic nocturnal nasal congestion who reported trouble sleeping.MethodsSubjects were randomized to BRNS or a placebo strip for approximately 8 h each night for 14 days. Efficacy was assessed in the clinic using the Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ).ResultsA total of 140 subjects were randomized in Study 1, and 130 in Study 2. There was no significant difference between BRNS and placebo on either the NRQLQ “Sleep Problems” domain or the “Feel Tired and Unrefreshed” item of the “Symptoms on Waking in the Morning” domain at day 7 or 14. There was, however, a significant change in the least squares mean difference from baseline to days 7 and 14 in both the BRNS and placebo arms for each of these endpoints. BRNS were well tolerated.ConclusionsBRNS did not significantly improve subjective measures of sleep quality and nasal congestion compared with placebo strips in this population of chronic nocturnal congestion sufferers with self-reported sleep impairment, possibly due to a strong placebo effect.FundingGlaxoSmithKline Consumer Healthcare.ClinicalTrials.gov Registration NumbersStudy 1: NCT03549117; Study 2: NCT03549130.
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