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

Skin Health Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03641430
• Other study ID #: IRB00180361
• Status: Withdrawn
• Phase: N/A
• Start date: December 2021
• Est. completion date: February 2025

Study information

• Verified date: June 2022
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Skin Health

Intervention

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.

Locations

Country	Name	City	State
United States	Cutaneous Translational Research Program, Department of Dermatology, Johns Hopkins University School of Medicine	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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