Photoaged SkinPhase 1NCT02889159
Immunologic Profile of Chronically Photodamaged Skin
A Phase 1 study testing Candida albicans antigen, histamine phosphate and imiquimod 5% cream in people with Photoaged Skin and Normal Skin, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Photoaged Skin, Normal Skin
- What is being tested?
- Candida albicans antigen, histamine phosphate and imiquimod 5% cream
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2016to 23 Feb 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Department of Dermatology
Ann Arbor, Michigan, 48109
About this study
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.
Read the 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
Previous versions of this record incorrectly listed the phase of this study. The record has been corrected to reflect the correct phase.
- Conditions
- Photoaged Skin, Normal Skin
- Being tested
- Candida albicans antigen, histamine phosphate, imiquimod 5% cream, Tape Stripping
- Keywords
- photoaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Candida albicans antigenBiological
Also called CANDIN
0.1 milliliter (mL) injection into superficial dermis making small bleb at Baseline Visit.
histamine phosphateBiological
Also called HISTATROL
0.01 milliliter (mL) of histamine phosphate injected into the superficial dermis making a small bleb at Baseline Visit.
imiquimod 5% creamBiological
Also called ALDARA
Pea sized amount of 5% cream to be applied to designated areas once daily for 4 days, beginning at Baseline Visit.
Tape StrippingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Candida albicans antigen | Other | useful in measuring the capacity of a person to manifest a delayed-type hypersensitivity response Receives: Biological: Candida albicans antigen |
| histamine phosphate | Other | useful to assess type I IgE-mediated hypersensitivity reactions Receives: Biological: histamine phosphate |
| imiquimod 5% cream | Other | direct stimulator of TLR-7, a key component of the innate immune response with downstream signaling effects involving the adaptive immune response Receives: Biological: imiquimod 5% cream |
| tape stripping | Other | to create alterations in key inflammatory mediators involved in both the innate and adaptive immune responses Receives: Procedure: Tape Stripping |
| Control | No intervention | control sample from both sun exposed and non-sun exposed skin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 5 days
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).
Measured: 5 days
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).
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study start6 Jun 2016
- Primary completion9 Feb 2023
- Study completion23 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Photoaged SkinStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yolanda Rosi Helfrich, University of Michigan
- Investigators
- Yolanda Helfrich, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02889159
- Sponsor's protocol ID
- HUM00111845 / Derm 681
- Status last verified
- Feb 2025
- First submitted
- 6 Jun 2016
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunologic Profile of Chronically Photodamaged Skin
- ClinicalTrials.gov ID
- NCT02889159
- Acronym / sponsor ID
- HUM00111845 / Derm 681
- Conditions
- Photoaged Skin, Normal Skin
- Keywords
- photoaging
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 6 Jun 2016 (actual)
- Primary completion
- 9 Feb 2023 (actual)
- Study completion
- 23 Feb 2023 (actual)
- First posted
- 5 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Previous versions of this record incorrectly listed the phase of this study. The record has been corrected to reflect the correct phase.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Candida albicans antigen | Other | Biological: Candida albicans antigenuseful in measuring the capacity of a person to manifest a delayed-type hypersensitivity response |
| histamine phosphate | Other | Biological: histamine phosphateuseful to assess type I IgE-mediated hypersensitivity reactions |
| imiquimod 5% cream | Other | Biological: imiquimod 5% creamdirect stimulator of TLR-7, a key component of the innate immune response with downstream signaling effects involving the adaptive immune response |
| tape stripping | Other | Procedure: Tape Strippingto create alterations in key inflammatory mediators involved in both the innate and adaptive immune responses |
| Control | No intervention | –control sample from both sun exposed and non-sun exposed skin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Candida albicans antigenAlso: CANDIN0.1 milliliter (mL) injection into superficial dermis making small bleb at Baseline Visit. | Biological | Candida albicans antigen |
| histamine phosphateAlso: HISTATROL0.01 milliliter (mL) of histamine phosphate injected into the superficial dermis making a small bleb at Baseline Visit. | Biological | histamine phosphate |
| imiquimod 5% creamAlso: ALDARAPea sized amount of 5% cream to be applied to designated areas once daily for 4 days, beginning at Baseline Visit. | Biological | imiquimod 5% cream |
| Tape StrippingAt 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. | Procedure or surgery | tape stripping |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Photoaged Skin
Recruiting
Study of RRS® HA Long Lasting for Improving Facial Wrinkles and Skin Quality
Photoaged Facial Skin, Photoaging
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yolanda Helfrich, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Candida albicans antigen, histamine phosphate and imiquimod 5% cream in people with Photoaged Skin and Normal Skin, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Erythema in photodamaged and photoprotected skin (time frame: 5 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025; AzTrials last refreshed its copy on 6 Nov 2026.