Immunologic Profile of Chronically Photodamaged Skin

Status: Completed
Location: See location...
Intervention Type: Biological, Procedure
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
United States
Michigan
University of Michigan Department of Dermatology
Ann Arbor
Time Frame
Start Date: 2016-06-06
Completion Date: 2023-02-23
Participants
Target number of participants: 40
Treatments
Other: Candida albicans antigen
useful in measuring the capacity of a person to manifest a delayed-type hypersensitivity response
Other: histamine phosphate
useful to assess type I IgE-mediated hypersensitivity reactions
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
Other: tape stripping
to create alterations in key inflammatory mediators involved in both the innate and adaptive immune responses
No_intervention: Control
control sample from both sun exposed and non-sun exposed skin
Sponsors
Leads: University of Michigan

This content was sourced from clinicaltrials.gov

Similar Clinical Trials

We couldn't find any related articles check for more on the main search page.