Clinical trial NCT06174493: Investigating Participation Patterns of Patients in Atopic Dermatitis Clinical Trials
Official title: Understanding Patient Engagement Trends in Atopic Dermatitis Clinical Research
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Atopic Dermatitis
Keywords: atopic dermatitis
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-12-18
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with atopic dermatitis who are actively considering enrolling in a clinical study for said condition, but have not yet completed enrollment and randomization.

Brief summary: Clinical trials, specifically focused on atopic dermatitis, are crucial in assessing the safety and efficacy of new treatments. These trials serve as fundamental instruments in determining whether emerging medications outperform standard therapies, providing compelling evidence to support wider implementation.

The main goal is to thoroughly scrutinize trial completion rates and voluntary withdrawals among this particular group of patients.


Eligibility criteria: Inclusion Criteria:

* Ability to understand and the willingness to sign a written informed consent document
* Participant must be 18 years of age or older
* Confirmed diagnosis of atopic dermatitis

Exclusion Criteria:

* Enrolled in another research study
* Is pregnant, breastfeeding or expecting to conceive within the projected duration of the study
* Inability to provide written informed consent

Primary outcomes:
measure: Number of atopic dermatitis patients who decide to enroll in a clinical research
timeFrame: 3 months
measure: Rate of atopic dermatitis patients who remain in clinical trial to trial completion
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Power Life Sciences
state: California
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: Shalom G, Kridin K, Raviv KO, Freud T, Comaneshter D, Friedland R, Cohen AD, Ben-Amitai D. Atopic Dermatitis and Celiac Disease: A Cross-Sectional Study of 116,816 Patients. Am J Clin Dermatol. 2020 Feb;21(1):133-138. doi: 10.1007/s40257-019-00474-2.
citation: Schut C, Dalgard FJ, Bewley A, Evers AWM, Gieler U, Lien L, Sampogna F, Stander S, Tomas-Aragones L, Vulink N, Finlay AY, Legat FJ, Titeca G, Jemec GB, Misery L, Szabo C, Grivcheva-Panovska V, Spillekom-van Koulil S, Balieva F, Szepietowski JC, Reich A, Roque Ferreira B, Lvov A, Romanov D, Marron SE, Gracia-Cazana T, Svensson A, Altunay IK, Thompson AR, Zeidler C, Kupfer J; ESDAP Study collaborators. Body dysmorphia in common skin diseases: results of an observational, cross-sectional multicentre study among dermatological outpatients in 17 European countries. Br J Dermatol. 2022 Jul;187(1):115-125. doi: 10.1111/bjd.21021. Epub 2022 May 22.
citation: Patruno C, Fabbrocini G, Longo G, Argenziano G, Ferrucci SM, Stingeni L, Peris K, Ortoncelli M, Offidani A, Amoruso GF, Talamonti M, Girolomoni G, Grieco T, Iannone M, Nettis E, Foti C, Rongioletti F, Corazza M, Veneri MD, Napolitano M; Dupilumab for Atopic Dermatitis of the Elderly (DADE) Study Group. Effectiveness and Safety of Long-Term Dupilumab Treatment in Elderly Patients with Atopic Dermatitis: A Multicenter Real-Life Observational Study. Am J Clin Dermatol. 2021 Jul;22(4):581-586. doi: 10.1007/s40257-021-00597-5.