Immunologic Profile of Chronically Photodamaged Skin
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|ClinicalTrials.gov Identifier: NCT02889159|
Recruitment Status : Recruiting
First Posted : September 5, 2016
Last Update Posted : May 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Photoaged Skin Normal Skin||Biological: Candida albicans antigen Biological: histamine phosphate Biological: imiquimod 5% cream Procedure: Tape Stripping||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Immunologic Profile of Chronically Photodamaged Skin|
|Actual Study Start Date :||June 6, 2016|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2020|
Candida albicans antigen
useful in measuring the capacity of a person to manifest a delayed-type hypersensitivity response
Biological: Candida albicans antigen
0.1 milliliter (mL) injection into superficial dermis making small bleb at Baseline Visit.
Other Name: CANDIN
useful to assess type I IgE-mediated hypersensitivity reactions
Biological: histamine phosphate
0.01 milliliter (mL) of histamine phosphate injected into the superficial dermis making a small bleb at Baseline Visit.
Other Name: HISTATROL
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
Biological: imiquimod 5% cream
Pea sized amount of 5% cream to be applied to designated areas once daily for 4 days, beginning at Baseline Visit.
Other Name: ALDARA
to create alterations in key inflammatory mediators involved in both the innate and adaptive immune responses
Procedure: Tape Stripping
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
- 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).
- 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).
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02889159
|Contact: Jennifer Bellemail@example.com|
|Contact: Bethany Ruffinofirstname.lastname@example.org|
|United States, Michigan|
|University of Michigan Department of Dermatology||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: Jennifer Bell 734-936-4075 email@example.com|
|Contact: Bethany Ruffino 734-763-8076 firstname.lastname@example.org|
|Principal Investigator:||Yolanda Helfrich, MD||University of Michigan|