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History of Changes for Study: NCT05945784
Exploring Accessible Beauty for Individuals With Upper Extremity Deficits
Latest version (submitted December 4, 2023) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 12, 2023 None (earliest Version on record)
2 August 15, 2023 Recruitment Status, Study Status, Contacts/Locations and Oversight
3 December 4, 2023 Recruitment Status, Study Status, Contacts/Locations and Study Design
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Study NCT05945784
Submitted Date:  July 12, 2023 (v1)
Open or close this module Study Identification
Unique Protocol ID: IRB: 000000001
Brief Title: Exploring Accessible Beauty for Individuals With Upper Extremity Deficits
Official Title: Exploring Accessible Beauty: A Study on Enhancing Beauty Product Accessibility for Individuals With Upper Extremity Deficits
Secondary IDs:
Open or close this module Study Status
Record Verification: July 2023
Overall Status: Not yet recruiting
Study Start: July 21, 2023
Primary Completion: October 2023 [Anticipated]
Study Completion: December 2023 [Anticipated]
First Submitted: June 27, 2023
First Submitted that
Met QC Criteria:		 July 12, 2023
First Posted: July 14, 2023 [Actual]
Last Update Submitted that
Met QC Criteria:		 July 12, 2023
Last Update Posted: July 14, 2023 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Casa Colina Hospital and Centers for Healthcare
Responsible Party: Principal Investigator
Investigator: Emily Rosario
Official Title: Executive Director
Affiliation: Casa Colina Hospital and Centers for Healthcare
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
Brief Summary: The purpose of this study is to investigate the accessibility of beauty products for individuals with upper extremity disabilities. By examining various factors such as packaging design, product applicators, and ease of use, this research aims to identify barriers faced by individuals with upper extremity disabilities or visual deficits when using beauty products. The study seeks to provide insights and recommendations for improving the accessibility of beauty products, ultimately promoting inclusivity and enhancing the overall beauty experience for individuals with disabilities.
Detailed Description:

Individuals with upper extremity disabilities face unique challenges when it comes to using beauty products. These disabilities can include conditions such as limb loss, limited mobility, or dexterity impairments, which can significantly impact their ability to engage in self-care and beauty routines. The accessibility of beauty products is crucial to ensure that individuals with upper extremity disabilities have equal opportunities to participate in activities that promote self-expression and confidence.

Research in the field of accessible design has highlighted the importance of inclusive product development across various industries, including cosmetics and personal care. However, limited attention has been given specifically to beauty products and their usability for individuals with upper extremity disabilities.

To address this gap, studies are being conducted to assess the accessibility of beauty products and identify potential barriers and solutions. These studies typically examine factors such as packaging design, ergonomics of product applicators, ease of grip, and maneuverability. By understanding the specific challenges faced by individuals with upper extremity disabilities, researchers can propose modifications and design considerations that enhance accessibility.
Open or close this module Conditions
Conditions: Stroke, Ischemic
Stroke Hemorrhagic
Stroke (CVA) or TIA
Stroke, Acute
Traumatic Brain Injury
SCI - Spinal Cord Injury
Ehlers-Danlos Syndromes (EDS)
Lupus Erythematosus
Guillain-Barre Syndrome
Multiple Sclerosis
Myasthenia Gravis
Amyotrophic Lateral Sclerosis
Graves Disease
Muscular Dystrophies
Keywords: upper extremity disabilities
limited mobility
dexterity impairments
muscle weakness
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Case-Only
Time Perspective: Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 60 [Anticipated]
Number of Groups/Cohorts 1
Open or close this module Groups and Interventions
Groups/Cohorts Interventions
Minimal to moderate upper extremity deficits
  • Individuals aged 18 years to 55 years.
  • Minimal to moderate upper extremity deficits, including but not limited to limited mobility or dexterity impairments.
  • Regular users of beauty products.
  • Able to understand and communicate in the language of the study.
 Use of Rare Beauty makeup products
Participants will be provided with a selection of beauty products items including foundation, concealer, blush, highlighter, and lipstick, specifically chosen for their potential accessibility features. They will have a specified trial period during which they can use the products as part of their regular beauty routines.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Likert Scale
[ Time Frame: Complete on Day 7 ]

It is a validated self-reported instrument to assess packaging of the makeup. A few questions will focus on shape of the cap, length of the wand, shape of the doe foot, finish of the components, how it affects grip, and weight of the component/applicator. Possible scores range from 1 (strongly disagree) to 5 (strongly agree).
2. Likert Scale
[ Time Frame: Complete on Day 14 ]

It is a validated self-reported instrument to assess packaging of the makeup. A few questions will focus on shape of the cap, length of the wand, shape of the doe foot, finish of the components, how it affects grip, and weight of the component/applicator. Possible scores range from 1 (strongly disagree) to 5 (strongly agree).
3. Pre-test Questionnaire
[ Time Frame: At baseline ]

Participants will complete questionnaires that assess their demographics, disability characteristics, and previous experiences with beauty products.
4. Accessibility Evaluation
[ Time Frame: Day 7, after use of beauty products ]

Participants will evaluate the beauty products based on predefined criteria, including ease of grip, maneuverability, packaging design, and product applicators. They will document their experiences, challenges faced, and any suggestions for improvements. Possible scores range from 1 (strongly disagree) to 5 (strongly agree).
5. Accessibility Evaluation
[ Time Frame: Day 14, after use of beauty products at end of study ]

Participants will evaluate the beauty products based on predefined criteria, including ease of grip, maneuverability, packaging design, and product applicators. They will document their experiences, challenges faced, and any suggestions for improvements. Possible scores range from 1 (strongly disagree) to 5 (strongly agree).
6. Post-test Questionnaire
[ Time Frame: Day 14, after use of beauty products at end of study ]

Participants will assess changes in their perceptions and experiences with the beauty products. This will include questions about satisfaction, usability, and any perceived improvements in accessibility. Possible scores range from 1 (strongly disagree) to 5 (strongly agree).
Open or close this module Eligibility
Study Population: A convenience sample of individuals aged 18 and above, with upper extremity deficits, will be recruited for this study. Efforts will be made to include participants with a range of upper extremity deficits and experiences with beauty products.
Sampling Method: Non-Probability Sample
Minimum Age: 18 Years
Maximum Age: 55 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

Individuals aged 18 years to 55 years.

  • Minimal to moderate upper extremity deficits, including but not limited to limited mobility or dexterity impairments.
  • Regular users beauty products.
  • Able to understand and communicate in the language of the study.

Exclusion Criteria:

  • Individuals below 18 years of age or over the age of 55.
  • Individuals without upper extremity deficits or with severe upper extremity deficits that may affect the participant's ability to engage in study activities.
  • Participants who are not regular users of beauty products.
  • Inability to understand and communicate in the language of the study.
  • Any medical or psychological condition that may affect the participant's ability to provide informed consent or engage in the study activities safely.
  • Individuals who experience facial skin or eye irritation reported by subject or observed by evaluator at baseline visit
  • History of allergic reactions, and/or known allergies to cosmetic ingredients, toiletries, sunscreens, etc.
  • Immunocompromised subjects
  • Individuals who may experience changes in hormones, such as just those using oral contraception for less than three months before the screening visit or who have changed hormonal contraceptive methods within the three months before the Baseline visit or planning to modify hormonal contraception treatment within the duration of the study.
  • Known to be pregnant, lactating or planning to become pregnant within six months. Subjects who become pregnant during the study must inform the Principal Investigator immediately.
Open or close this module Contacts/Locations
Central Contact Person: Niko Fullmer
Telephone: 909-596-7733 Ext. 2220
Email: nfullmer@casacolina.org
Study Officials: Emily Rosario, PhD
Principal Investigator
Casa Colina Hospital and Centers for Healthcare
Locations: United States, California
Casa Colina Hospital and Centers for Healthcare
Pomona, California, United States, 91767
Contact:Contact: Supervisor 909-596-7733 Ext. 2220 nfullmer@casacolina.org
Contact:Sub-Investigator: Esther Bae, OTD
Contact:Sub-Investigator: Hannah Cone, DPT
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations: Skelton H, Gill S, Al Zidjaly N, et al. Exploring the Accessibility of Beauty Products for Individuals with Mobility Disabilities. J Appl Cosmetol. 2020;38(3):65-72.
Smith A, Johnson R, Thompson A, et al. Enhancing Accessibility: Designing Inclusive Beauty Products for All Abilities. J Inclusive Design. 2021;1(2):89-102
Chen L, Kim D, Park J, et al. A Review on Product Accessibility Evaluation Methods for People with Disabilities. Int J Ind Ergon. 2019;71:103-117. doi:10.1016/j.ergon.2018.11.007
Links:
Available IPD/Information:
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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services