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

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ClinicalTrials.gov Identifier: NCT03641430
Recruitment Status : Withdrawn (The study design will need to be changed completely becasue of the change of research interest. We have decided to withdraw the study.)
First Posted : August 22, 2018
Last Update Posted : December 28, 2020
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Study Description
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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
Skin Health Other: Supportive care with OCT product Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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
Estimated Study Start Date : December 2021
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : February 2025

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Arms and Interventions
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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
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Primary Outcome Measures :
  1. Photoaging [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03641430


Locations
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United States, Maryland
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
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Principal Investigator: Anna Chien Johns Hopkins University
More Information
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Publications:

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03641430    
Other Study ID Numbers: IRB00180361
First Posted: August 22, 2018    Key Record Dates
Last Update Posted: December 28, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No