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

Sponsor
Johns Hopkins University (Other)
Overall Status
Withdrawn
CT.gov ID
NCT03641430
Collaborator
(none)
0
Enrollment
1
Location
1
Arm
38
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Supportive care with OCT product
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
The Effects of Over-the-Counter Products on the Skin
Anticipated Study Start Date :
Dec 1, 2021
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Feb 1, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cutaneous Translational Research Program, Department of Dermatology, Johns Hopkins University School of Medicine Baltimore Maryland United States 21287

Sponsors and Collaborators

  • Johns Hopkins University

Investigators

  • Principal Investigator: Anna Chien, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT03641430
Other Study ID Numbers:
  • IRB00180361
First Posted:
Aug 22, 2018
Last Update Posted:
Jun 30, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 30, 2022