Photoaged Skin Clinical Trial
Official title:
Immunologic Profile of Chronically Photodamaged Skin
Chronically photodamaged skin is visually characterized by dryness, wrinkles, brown spots, leathery appearance, etc. This happens as a result of excessive exposure to UV light from the sun. While the sun's exposure 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 examine the lasting changes in the immune system of the skin caused by UV exposure. Investigators will stimulate different aspects of the skin's immune system by giving an injection of Candida Albicans (CANDIN®) and histamine phosphate (HISTATROL®), topical applications of imiquimod 5% cream (ALDARA®) and performing a tape stripping procedure with adhesive tape. The use of Candida Albicans (CANDIN®), histamine phosphate (HISTATROL®), and tape stripping are common procedures in clinical settings to stimulate skin desired skin responses. Imiquimod 5% cream (ALDARA®) is an FDA-approved drug for the treatment of basal cell carcinomas, actinic keratoses and genital warts. Investigators will compare the reaction of the skin's immune system on a cellular level from skin normally exposed to the sun exposure to an area normally hidden from sun exposure.
| Status | Recruiting |
| Enrollment | 40 |
| Est. completion date | December 2024 |
| Est. primary completion date | December 2024 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Michigan Department of Dermatology | Ann Arbor | Michigan |
| Lead Sponsor | Collaborator |
|---|---|
| University of Michigan |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Erythema in photodamaged and photoprotected skin | 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 | |
| Primary | Human Beta Defensin 2 (DEFB4) Fold Change | 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 | |
| Primary | Wheal Response in photodamaged and photoprotected skin | Measured in millimeters (mm) with standardized induration measurements at baseline visit/visit 1 and visit 2 (visit 1 + 48 hours +/- 12 hours). | 5 days |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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