The Effects of Over-the-Counter Products on the Skin

NCT03641430 | Withdrawn

• 1 other identifier: IRB00180361
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this study is to investigate the safety and tolerability of commonly used over-the-counter products and the effects of the products on skin health.

Conditions

Skin Health

Outcome Measures

Primary Outcomes (1)

• Photoaging

  This will be assessed using the Griffiths Photoaging Photonumeric scale with range from 1 to 10 with increasing numbers representing advanced photoaging

  1 year

Study Arms (1)

Supportive care with Over-the-Counter (OCT) product

EXPERIMENTAL

Participants will apply over-the-counter product for a certain period with or without light challenge

Other: Supportive care with OCT product

Interventions

Supportive care with OCT product OTHER

Participants will apply over-the-counter product for a certain period with or without light challenge. We will perform clinical assessments of the skin associated with product application as well as assess these changes with and without light challenge. Skin biopsies will be obtained following standard medical practice and will be used to analyze skin markers related to photoaging, pigmentation, oxidative stress, and other dermatologic conditions.

Supportive care with Over-the-Counter (OCT) product

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be over the age of 18 years old with healthy skin;
• Participant must be willing and comply with the requirements of the protocol;
• Participant must have the ability to understand and communicate with the investigator;
• Participant must provide informed consent.

You may not qualify if:

• Subjects who are unable to provide informed consent;
• Subject with significant medical history or current skin diseases that the investigator feels is not safe for study participation;
• Subjects who self-report that they are pregnant or nursing;
• Subjects who do not speak English or have difficulty hearing or are otherwise impaired for providing informed consent and communicating with the investigator;
• Subjects with known bleeding disorders or diathesis;
• Subjects with a history of keloids or excessive scarring;
• Subjects with known allergy to lidocaine, epinephrine, or any of the tested products;
• Subjects who foresee intensive UV exposure during the study (e.g. sunbathing, tanning beds).

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Cutaneous Translational Research Program, Department of Dermatology, Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

• Naylor EC, Watson RE, Sherratt MJ. Molecular aspects of skin ageing. Maturitas. 2011 Jul;69(3):249-56. doi: 10.1016/j.maturitas.2011.04.011. Epub 2011 May 25.

  PMID: 21612880 BACKGROUND

MeSH Terms

Interventions

Palliative Care

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Anna Chien

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2018
• First Posted: August 22, 2018
• Study Start: December 1, 2021
• Primary Completion: June 1, 2024
• Study Completion: February 1, 2025
• Last Updated: June 30, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)