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

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.

Study Overview

• Status: Withdrawn
• Conditions: Skin Health
• Intervention / Treatment: Other: Supportive care with OCT product

Detailed Description

Participant will apply commonly used skin product on skin for a period of time with or without light challenge. The investigators 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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Cutaneous Translational Research Program, Department of Dermatology, Johns Hopkins University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Supportive care with Over-the-Counter (OCT) product; Participants will apply over-the-counter product for a certain period with or without light challenge

Other: Supportive care with OCT product; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Anna Chien, Johns Hopkins University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2021
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): February 1, 2025

Study Registration Dates

• First Submitted: August 20, 2018
• First Submitted That Met QC Criteria: August 20, 2018
• First Posted (Actual): August 22, 2018

Study Record Updates

• Last Update Posted (Actual): June 30, 2022
• Last Update Submitted That Met QC Criteria: June 28, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: IRB00180361

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No