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

Not Applicable

Withdrawn

• Conditions: Skin Health
• Interventions: Other: Supportive care with OCT product

• Registration Number: NCT03641430
• Lead Sponsor: Johns Hopkins University

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.

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 Timeline

• Study First Submitted: 2018-08-20
• Study First Submitted QC: 2018-08-20
• Study First Posted: 2018-08-22
• Study Start: 2021-12
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-28
• Last Update Posted: 2022-06-30
• Primary Completion: 2024-06
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

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

Trial Locations

Locations (1)

Cutaneous Translational Research Program, Department of Dermatology, Johns Hopkins University School of Medicine; 🇺🇸 Baltimore, Maryland, United States