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Immunologic Agents for Skin Photoaging
Phase 4
Recruiting
Led By Yolanda Helfrich, MD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject is at least 18 years of age
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 days
Awards & highlights
Study Summary
This trial will examine the long-term effects of exposure to UV light on the skin's immune system.
Who is the study for?
This trial is for adults with either severe sun-damaged skin or no skin damage, who are in good health and not on medications that could affect the study. Women must be non-pregnant, non-nursing, and if of childbearing potential, using stable birth control. People with autoimmune skin diseases, recent steroid or antibiotic use, abnormal blood counts, severe allergies or asthma can't participate.Check my eligibility
What is being tested?
The study tests how chronically sun-damaged skin's immune system responds to stimuli compared to undamaged skin. It uses Candida albicans antigen and histamine phosphate injections, imiquimod cream application (an FDA-approved treatment), and tape stripping to provoke immune responses for analysis.See study design
What are the potential side effects?
Possible side effects include local reactions at the test site like redness or swelling from injections and cream application. Tape stripping might cause temporary discomfort or irritation. Imiquimod may also cause itching, burning sensation or worsen existing inflammation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Erythema in photodamaged and photoprotected skin
Human Beta Defensin 2 (DEFB4) Fold Change
Wheal Response in photodamaged and photoprotected skin
Trial Design
5Treatment groups
Experimental Treatment
Active Control
Group I: tape strippingExperimental Treatment1 Intervention
to create alterations in key inflammatory mediators involved in both the innate and adaptive immune responses
Group II: imiquimod 5% creamExperimental Treatment1 Intervention
direct stimulator of TLR-7, a key component of the innate immune response with downstream signaling effects involving the adaptive immune response
Group III: histamine phosphateExperimental Treatment1 Intervention
useful to assess type I IgE-mediated hypersensitivity reactions
Group IV: Candida albicans antigenExperimental Treatment1 Intervention
useful in measuring the capacity of a person to manifest a delayed-type hypersensitivity response
Group V: ControlActive Control1 Intervention
control sample from both sun exposed and non-sun exposed skin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
imiquimod 5% cream
2008
Completed Phase 4
~30
Find a Location
Who is running the clinical trial?
University of MichiganLead Sponsor
1,797 Previous Clinical Trials
6,378,018 Total Patients Enrolled
1 Trials studying Skin Photoaging
41 Patients Enrolled for Skin Photoaging
Yolanda Helfrich, MDPrincipal InvestigatorUniversity of Michigan
2 Previous Clinical Trials
93 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not able to become pregnant or have taken a pregnancy test and will use birth control during the study.I currently use a tanning bed or undergo phototherapy.I am currently on medication that suppresses my immune system.I have a history of conditions like rheumatoid arthritis or lupus.I have not taken antibiotics in the two weeks before joining the study or during it.I am currently taking antihistamine medication.I have active skin inflammation or infection.I have a history of skin conditions like eczema or psoriasis.I am currently taking tricyclic antidepressants.I have not used any experimental drugs or devices in the last two weeks.I am not pregnant nor planning to become pregnant.I am either male or female.I don't have any health issues that would affect test results.My skin is either severely damaged by the sun or has no sun damage.I have a history of severe heart, lung, or kidney disease, or very high or low blood pressure.I have not used any steroids, either as a cream or taken by mouth, in the last two weeks.I am 18 years old or older.I am currently breastfeeding.I am currently taking beta-blocker medications.
Research Study Groups:
This trial has the following groups:- Group 1: Candida albicans antigen
- Group 2: histamine phosphate
- Group 3: imiquimod 5% cream
- Group 4: tape stripping
- Group 5: Control
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has this treatment acquired the official sanction of the Food and Drug Administration?
"This treatment appears to be safe, as it has been approved for use in a Phase 4 trial. As such, its safety rating is 3 on the 1-3 scale used by Power."
Answered by AI
How many participants are selected to join this research endeavor?
"Correct. According to the clinicaltrials.gov listings, this research endeavor is actively recruiting participants since its inception on June 6th 2016 and most recent edit on May 18th 2022. The total number of required patients for recruitment is 40 from 1 site."
Answered by AI
Are there vacancies for potential participants in this research?
"Affirmative. The information hosted on clinicaltrials.gov attests that this medical experiment, which was originally launched on June 6th 2016, is actively searching for participants to enroll. 40 patients are needed from a single site of recruitment."
Answered by AI
What types of diseases or conditions is this therapy usually administered to?
"This treatment has been known to be successful at preventing migraine headaches, but it can also provide relief from conditions such as facial acne, basal cell carcinoma, and IgE allergies caused by allergens."
Answered by AI
Has this particular therapy been tested in prior clinical trials?
"Currently, there are 25 ongoing trials for this specific treatment with 5 in their final phase of development. Most notably, 87 different sites across the country are participating in these studies and a number of them reside within New Haven, Connecticut."
Answered by AI
Who else is applying?
What state do they live in?
Michigan
How old are they?
18 - 65
What site did they apply to?
University of Michigan Department of Dermatology
What portion of applicants met pre-screening criteria?
Met criteria
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