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

NCT ID: NCT03641430

Last Updated: 2022-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-31

Study Completion Date

2025-02-28

Brief Summary

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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

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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.

Conditions

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Skin Health

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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

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

Group Type EXPERIMENTAL

Supportive care with OCT product

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anna Chien

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 21612880 (View on PubMed)

Other Identifiers

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IRB00180361

Identifier Type: -

Identifier Source: org_study_id

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