Skin HealthNCT03641430
The Effects of Over-the-Counter Products on the Skin
A study testing Supportive care with OCT product in people with Skin Health, run by Johns Hopkins University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Health
- What is being tested?
- Supportive care with OCT product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2021to Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Cutaneous Translational Research Program, Department of Dermatology, Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
About this study
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.
Read the 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.
- Conditions
- Skin Health
- Being tested
- Supportive care with OCT product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive care with OCT productOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Supportive care with Over-the-Counter (OCT) product | Experimental | Participants will apply over-the-counter product for a certain period with or without light challenge Receives: Other: Supportive care with OCT product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Photoaging
This will be assessed using the Griffiths Photoaging Photonumeric scale with range from 1 to 10 with increasing numbers representing advanced photoaging
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study startDec 2021 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionFeb 2025 (estimated)
Why it stopped: The study design will need to be changed completely becasue of the change of research interest. We have decided to withdraw the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Skin HealthStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Chien, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03641430
- Sponsor's protocol ID
- IRB00180361
- Status last verified
- Jun 2022
- First submitted
- 20 Aug 2018
- Last updated
- 30 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21612880
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Over-the-Counter Products on the Skin
- ClinicalTrials.gov ID
- NCT03641430
- Acronym / sponsor ID
- IRB00180361
- Conditions
- Skin Health
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study design will need to be changed completely becasue of the change of research interest. We have decided to withdraw the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Dec 2021 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 22 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care with Over-the-Counter (OCT) product | Experimental | Other: Supportive care with OCT productParticipants will apply over-the-counter product for a certain period with or without light challenge |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supportive care with OCT productParticipants 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. | Other | Supportive care with Over-the-Counter (OCT) product |
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
- Background: PubMed 21612880Naylor 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.
- Individual participant dataSharing planned: No
Related trials for Skin Health
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Enrolling by invitationPhase 2
Deployment and Evaluation of Humanoid Robotics in Coalition-Aligned Clinical Care Settings
Mobility Impairment, Clinical Workflow Optimization
RecruitingObservational study
Studies of Skin Microbes in Healthy People and in People With Skin Conditions
Eczema, Atopic Dermatitis
Not yet recruiting
Assessing Psoriasis Treatment Outcomes
Psoriasis
RecruitingObservational study
A Multilevel Approach to Connecting Underrepresented Populations to Clinical Trials
Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Chien principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supportive care with OCT product in people with Skin Health, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Photoaging (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03641430, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2022.