Safety of a formulation containing chitosan microparticles with chamomile: blind controlled clinical trial

ABSTRACT Objective: to evaluate the safety of a topical formulation containing chamomile microparticles coated with chitosan in the skin of healthy participants. Method: phase I blind, controlled, non-randomized, single-dose clinical trial with control for skin, base formulation, and formulation with microparticles. The variables analyzed were irritation and hydration by the Wilcoxon and Kruskall-Wallis tests. Results: the study started with 35 participants with a mean age of 26.3 years. Of these, 30 (85.71%) were female, 29 (82.90%) were white skinned and 32 (91.40%) had no previous pathologies. One participant was removed from the study reporting erythema at the site of application, and four other participants for not attending the last evaluation. In the 30 participants who completed the study, the tested formulation did not cause erythema, peeling, burning, pruritus or pain; there was an improvement in cutaneous hydration in the site of application of the formulation with microparticles. In the evaluation of the barrier function, there was an increase in transepidermal water loss in all sites. Conclusion: the formulation with chamomile microparticles is safe for topical use, not causing irritation and improving skin hydration over four weeks of use. Its effects on barrier function need further investigation. No. RBR-3h78kz in the Brazilian Registry of Clinical Trials (ReBEC).

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Immunogenicity and Safety of Inactivated Sabin-Strain Polio Vaccine “PoliovacSin”: Clinical Trials Phase I and II

Vaccines ◽

10.3390/vaccines9060565 ◽

2021 ◽

Vol 9 (6) ◽

pp. 565

Author(s):

Anastasia Piniaeva ◽

Georgy Ignatyev ◽

Liubov Kozlovskaya ◽

Yury Ivin ◽

Anastasia Kovpak ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Phase I ◽

Safety Profile ◽

Neutralizing Antibody ◽

Polio Eradication ◽

Controlled Clinical Trial ◽

Double Blind ◽

Good Tolerability ◽

Poliomyelitis Vaccine

Global polio eradication requires both safe and effective vaccines, and safe production processes. Sabin oral poliomyelitis vaccine (OPV) strains can evolve to virulent viruses and result in poliomyelitis outbreaks, and conventional inactivated poliomyelitis vaccine (Salk-IPV) production includes accumulation of large stocks of neurovirulent wild polioviruses. Therefore, IPV based on attenuated OPV strains seems a viable option. To increase the global supply of affordable inactivated vaccine in the still not-polio free world we developed an IPV made from the Sabin strains–PoliovacSin. Clinical trials included participants 18–60 years of age. A phase I single-center, randomized, double-blind placebo-controlled clinical trial included 60 participants, who received one dose of PoliovacSin or Placebo. A phase II multicenter, randomized, double-blind, comparative clinical trial included 200 participants, who received one dose of PoliovacSin or Imovax Polio. All vaccinations were well tolerated, and PoliovacSin had a comparable safety profile to the Placebo or the reference Imovax Polio preparations. A significant increase in neutralizing antibody levels to polioviruses types 1–3 (Sabin and wild) was observed in PoliovacSin and Imovax Polio vaccinated groups. Therefore, clinical trials confirmed good tolerability, low reactogenicity, and high safety profile of the PoliovacSin and its pronounced immunogenic properties. The preparation was approved for clinical trials involving infants.

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Qualitative study investigating the underlying motivations of healthy participants in phase I clinical trials

BMJ Open ◽

10.1136/bmjopen-2018-024224 ◽

2019 ◽

Vol 9 (1) ◽

pp. e024224 ◽

Cited By ~ 5

Author(s):

Kerry J Manton ◽

Cassandra S Gauld ◽

Katherine M White ◽

Paul M Griffin ◽

Suzanne L Elliott

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Phase I ◽

Time Frame ◽

Phase I Clinical Trial ◽

Trial Participation ◽

Phase I Clinical Trials ◽

Conducting Phase ◽

Patient Health ◽

Healthy Participants

ObjectivesIf patients are to reap the benefits of continued drug development, an understanding of why healthy participants take part in phase I clinical trials is imperative. The current study aimed to explore the nature of these underlying motivations which may, in turn, improve the overall participant experience and assist in the development of more effective recruitment and retention strategies.DesignThis study used a qualitative design based on the theory of planned behaviour. Specifically, it explored healthy participants’ underlying behavioural, control and normative beliefs which influence their participation in phase I clinical trials.SettingThis study took place at a company that specialises in conducting phase I and phase II clinical trials in the Australian state of Queensland.ParticipantsParticipants (n=31) were either currently undergoing a phase I clinical trial or had previously taken part in a phase I clinical trial.ResultsResults showed that the motivations were varied and not solely centred on financial gains. Reported advantages of participation included altruism, while inconvenience was most often reported as a disadvantage. Friends were reported as those most likely to approve, while one’s mother was reported as most likely to disapprove. Having a suitable time frame/flexible scheduling and feeling comfortable taking part in the trial were both the most commonly reported facilitators, while inflexible scheduling/time commitment was the most commonly reported barrier.ConclusionsPractical implications included the need for organisations involved in clinical trials to be mindful of inflexible scheduling and exploring the possibility of making educational materials available to family members who may be concerned about the risks associated with participation. Overall, it is anticipated that the results of this study will improve the understanding of factors that influence phase I clinical trial participation which may, ultimately, help develop new therapeutics to improve patient health.

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“Include me if you can”—reasons for low enrollment of pediatric patients in a psychopharmacological trial

Trials ◽

10.1186/s13063-021-05119-6 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Larissa Niemeyer ◽

Konstantin Mechler ◽

Jan Buitelaar ◽

Sarah Durston ◽

Bram Gooskens ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Demographic Data ◽

Autism Spectrum ◽

Current Therapy ◽

Future Research ◽

Controlled Clinical Trial ◽

Double Blind ◽

Clinical Patient ◽

Compulsive Disorder

Abstract Background Low recruitment in clinical trials is a common and costly problem which undermines medical research. This study aimed to investigate the challenges faced in recruiting children and adolescents with obsessive-compulsive disorder and autism spectrum disorder for a randomized, double-blind, placebo-controlled clinical trial and to analyze reasons for non-participation. The trial was part of the EU FP7 project TACTICS (Translational Adolescent and Childhood Therapeutic Interventions in Compulsive Syndromes). Methods Demographic data on pre-screening patients were collected systematically, including documented reasons for non-participation. Findings were grouped according to content, and descriptive statistical analyses of the data were performed. Results In total, n = 173 patients were pre-screened for potential participation in the clinical trial. Of these, only five (2.9%) were eventually enrolled. The main reasons for non-inclusion were as follows: failure to meet all inclusion criteria/meeting one or more of the exclusion criteria (n = 73; 42.2%), no interest in the trial or trials in general (n = 40; 23.1%), and not wanting changes to current therapy/medication (n = 14; 8.1%). Conclusions The findings from this study add valuable information to the existing knowledge on reasons for low clinical trial recruitment rates in pediatric psychiatric populations. Low enrollment and high exclusion rates raise the question of whether such selective study populations are representative of clinical patient cohorts. Consequently, the generalizability of the results of such trials may be limited. The present findings will be useful in the development of improved recruitment strategies and may guide future research in establishing the measurement of representativeness to ensure enhanced external validity in psychopharmacological clinical trials in pediatric populations. Trial registration EudraCT 2014-003080-38. Registered on 14 July 2014.

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Stratum Corneum Barrier Function in the Elderly-An Evaluation of Irritant Response to Sodium Lauryl Sulfate by Visual Scoring and Transepidermal Water Loss Measurements. Anastasia B. Cua, Klaus-P. Wilhelm, and Howard I. Maibach, Department of Dermatology, University of California, San Francisco, CA.

Dermatitis ◽

10.1097/01206501-199009000-00020 ◽

1990 ◽

Vol 1 (3) ◽

pp. 202

Author(s):

&NA;

Keyword(s):

Stratum Corneum ◽

San Francisco ◽

Water Loss ◽

Barrier Function ◽

Sodium Lauryl Sulfate ◽

The Elderly ◽

Transepidermal Water Loss ◽

University Of California ◽

Lauryl Sulfate ◽

Visual Scoring

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Skin Barrier Function in Psoriasis and Atopic Dermatitis: Transepidermal Water Loss and Temperature as Useful Tools to Assess Disease Severity

Journal of Clinical Medicine ◽

10.3390/jcm10020359 ◽

2021 ◽

Vol 10 (2) ◽

pp. 359 ◽

Cited By ~ 1

Author(s):

Trinidad Montero-Vilchez ◽

María-Victoria Segura-Fernández-Nogueras ◽

Isabel Pérez-Rodríguez ◽

Miguel Soler-Gongora ◽

Antonio Martinez-Lopez ◽

...

Keyword(s):

Atopic Dermatitis ◽

Disease Severity ◽

Water Loss ◽

Barrier Function ◽

Skin Barrier ◽

Transepidermal Water Loss ◽

Diagnostic Tools ◽

Psoriatic Skin ◽

Skin Barrier Function ◽

Healthy Controls

Multiple diagnostic tools are used to evaluate psoriasis and atopic dermatitis (AD) severity, but most of them are based on subjective components. Transepidermal water loss (TEWL) and temperature are skin barrier function parameters that can be objectively measured and could help clinicians to evaluate disease severity accurately. Thus, the aims of this study are: (1) to compare skin barrier function between healthy skin, psoriatic skin and AD skin; and (2) to assess if skin barrier function parameters could predict disease severity. A cross-sectional study was designed, and epidermal barrier function parameters were measured. The study included 314 participants: 157 healthy individuals, 92 psoriatic patients, and 65 atopic dermatitis patients. TEWL was significantly higher, while stratum corneum hydration (SCH) (8.71 vs. 38.43 vs. 44.39 Arbitrary Units (AU)) was lower at psoriatic plaques than at uninvolved psoriatic skin and healthy controls. Patients with both TEWL > 13.85 g·m−2h−1 and temperature > 30.85 °C presented a moderate/severe psoriasis (psoriasis area severity index (PASI) ≥ 7), with a specificity of 76.3%. TEWL (28.68 vs. 13.15 vs. 11.60 g·m−2 h−1) and temperature were significantly higher, while SCH (25.20 vs. 40.95 vs. 50.73 AU) was lower at AD eczematous lesions than uninvolved AD skin and healthy controls. Patients with a temperature > 31.75 °C presented a moderate/severe AD (SCORing Atopic Dermatitis (SCORAD) ≥ 37) with a sensitivity of 81.8%. In conclusion, temperature and TEWL values may help clinicians to determine disease severity and select patients who need intensive treatment.

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