- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02889159
Immunologic Profile of Chronically Photodamaged Skin
Study Overview
Status
Conditions
Detailed Description
Chronically photodamaged skin is visually characterized by dryness, wrinkles, brown spots, leathery appearance, etc. While photodamage leaves the skin's surface visibly changed, the skin's unseen immune system may also be permanently altered as a result of the exposure, making it more likely to develop a variety of skin cancers and infections.
This study will aim to evaluate the lasting changes that lifetime UV exposure causes to the different components of the skin's immune system in chronically sun damaged skin (forearms) compared to sun-protected skin (buttocks). Investigators will compare the cellular responses to stimulation of the skin's innate immune system, the skin's adaptive immune system, and the skin's hypersensitivity responses between these two sites.
In order to stimulate the different arms of the immune system, investigators will be using the following interventions: an intradermal injection of Candida Albicans antigen, an intradermal injection of histamine phosphate, a topical application of imiquimod 5% cream, and a tape stripping procedure with adhesive tape. Skin testing with the C. albicans antigen is a useful procedure for measuring the capacity of a person to manifest a delayed-type hypersensitivity response and is commonly used in clinical settings to evaluate cellular immunity. Similarly, histamine phosphate is frequently used as a positive control in clinical tests to assess type I Immunoglobulin E (IgE)-mediated hypersensitivity reactions. Imiquimod 5% cream is a direct stimulator of toll-like receptor (TLR) 7, a key component of the innate immune response with downstream signaling effects involving the adaptive immune response. It is FDA-approved for the treatment superficial basal cell carcinomas, actinic keratoses, and genital warts. Finally, tape stripping is a validated procedure used to remove superficial layers of the epidermis in clinical study environments.
Objective: This is a mechanism of action pilot study designed to characterize the molecular nature of the local innate and adaptive immune response in chronically photodamaged skin (forearm) as compared to photoprotected skin (buttocks) using non-photodamaged individuals (forearms and buttocks) as a control.
Population: Adult subjects with or without photodamage will be entered into the study at the University of Michigan.
Procedures: study interventions (tape stripping, candida albicans and histamine phosphate injections, imiquimod 5% cream application), photography, Chroma Meter reading, biopsies, skin assessment
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Nicole Nechiporchik
- Phone Number: 734-936-7519
- Email: nnechipo@med.umich.edu
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- Recruiting
- University of Michigan Department of Dermatology
-
Contact:
- Nicole Nechiporchik
- Phone Number: 734-936-7519
- Email: nnechipo@med.umich.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male or female
- Subject is at least 18 years of age
- Good general health
- No disease states, physical conditions or medications that would impair evaluation of the test sites
- Willingness and ability to follow protocol
- Signed, written, and witnessed informed consent form
- Subject to have either severe clinical photodamage or no clinical photodamage
- If female, subjects who are either of non-childbearing potential (defined as post-menopausal-absence of menstrual bleeding for 1 year - or as having undergone bilateral tubal ligation, hysterectomy or bilateral oophorectomy), or, if of childbearing potential, subjects who have had a negative urine pregnancy test at the beginning of the study, and have agreed to practice appropriate birth control to prevent pregnancy during the study. The type and dose of birth control must have been stable for at least 3 months prior to study entry and not be expected to change during the study.
Exclusion Criteria:
- Current tanning bed use or phototherapy
- Individuals who have lidocaine sensitivity
- Subjects with severe allergies manifested by a history of anaphylaxis, or history of presence of multiple severe allergies
- Subjects with a history of asthma
- Subjects on topical or systemic antihistamine therapy
- Subjects on tricyclic antidepressant therapy
- Subjects on beta-blocker medications
- Subjects on any immunosuppressive therapy
- Subjects with active inflammation or infection on the skin
- Subjects with a history of connective tissues diseases including rheumatoid arthritis, scleroderma, polymyositis/dermatomyositis or systemic lupus erythematosus
- Subjects with a history of inflammatory or autoimmune skin disease (including atopic dermatitis, eczema, or psoriasis)
- Subjects with a history of abnormal blood counts within the past one year
- Subjects with a history of hypotension, severe hypertension, severe cardiac, pulmonary, or renal disease
- Subjects with a history of keloid formation or hypertrophic scarring
- Topical or systemic steroid use in the two weeks prior to study entry
- Antibiotic use in the two weeks prior to study entry or during the study
- Has received an experimental drug or used an experimental device in the two weeks prior to study entry
- Females who are pregnant or planning to become pregnant
- Nursing females
- Any other treatments that at the Investigator's judgment is likely to interfere with the study evaluation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Candida albicans antigen
useful in measuring the capacity of a person to manifest a delayed-type hypersensitivity response
|
0.1 milliliter (mL) injection into superficial dermis making small bleb at Baseline Visit.
Other Names:
|
Other: histamine phosphate
useful to assess type I IgE-mediated hypersensitivity reactions
|
0.01 milliliter (mL) of histamine phosphate injected into the superficial dermis making a small bleb at Baseline Visit.
Other Names:
|
Other: imiquimod 5% cream
direct stimulator of TLR-7, a key component of the innate immune response with downstream signaling effects involving the adaptive immune response
|
Pea sized amount of 5% cream to be applied to designated areas once daily for 4 days, beginning at Baseline Visit.
Other Names:
|
Other: tape stripping
to create alterations in key inflammatory mediators involved in both the innate and adaptive immune responses
|
At Baseline Visit, adhesive tape firmly applied to designated area for 2 seconds, then removed.
Procedure repeated between 20 and 50 times until skin is slightly red and tacky.
|
No Intervention: Control
control sample from both sun exposed and non-sun exposed skin
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Erythema in photodamaged and photoprotected skin
Time Frame: 5 days
|
Measured via the a* output value on the Chroma Meter at baseline visit/visit 1, visit 2 (visit 1 + 48 hours +/- 12 hours) and visit 3 (visit 1 + 96 hours +/- 12 hours).
|
5 days
|
Human Beta Defensin 2 (DEFB4) Fold Change
Time Frame: 5 days
|
DEFB4 will be measured in absolute units expressed as a fold change compared to the control using skin biopsy specimens obtained at visits baseline visit/visit 1 (n=2), visit 2 (visit 1 + 48 hours +/- 12 hours) (n=6), and visit 3 (visit 1 + 96 hours +/- 12 hours) (n=2).
|
5 days
|
Wheal Response in photodamaged and photoprotected skin
Time Frame: 5 days
|
Measured in millimeters (mm) with standardized induration measurements at baseline visit/visit 1 and visit 2 (visit 1 + 48 hours +/- 12 hours).
|
5 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yolanda Helfrich, MD, University of Michigan
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00111845 / Derm 681
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Normal Skin
-
Merete HaedersdalCompleted
-
National Cancer Institute (NCI)CompletedMenopause | Normal PhysiologyMongolia
-
National Cancer Institute (NCI)CompletedNormal PregnancyUnited States
-
Cosmetique Active InternationalCompletedUltraviolet-Induced Change in Normal SkinFrance, Brazil, Poland, Romania
-
Umeå UniversityCompletedIdiopathic Normal Pressure Hydrocephalus
-
Uppsala University HospitalUppsala University; Swedish Society for Medical ResearchRecruitingIdiopathic Normal Pressure Hydrocephalus (INPH)Sweden
-
Johns Hopkins UniversityUniversity of Utah; Integra LifeSciences CorporationCompletedIdiopathic Normal Pressure Hydrocephalus (INPH)United States, Canada, Sweden
-
L'OrealRecruitingSunscreen Sensitivity | Ultraviolet-Induced Change in Normal SkinRomania
Clinical Trials on Candida albicans antigen
-
Nielsen BioSciences, Inc.CompletedWarts | Human Papilloma VirusUnited States
-
Maastricht University Medical CenterDutch Diabetes Research FoundationCompletedDiabetes Mellitus | Polyneuropathies | Arthropathy, NeurogenicNetherlands
-
AerasUniversity of Oxford; European and Developing Countries Clinical Trials Partnership...CompletedHIV Infections | TuberculosisSouth Africa, Senegal
-
University of ArkansasAllermed Laboratories, Inc.Completed
-
Zagazig UniversityCompletedTriple Intralesional Immunotherapy Combination in Multiple Recalcitrant WartsEgypt
-
Janssen Research & Development, LLCCompleted
-
Zagazig UniversityCompleted
-
Qena Faculty of medicine, South Valley UniversityActive, not recruiting
-
Zagazig UniversityRecruitingWarts | Human Papilloma VirusEgypt
-
Mibelle AGWithdrawnErosion of Teeth, UnspecifiedSwitzerland