Skin DiseasesEarly Phase 1NCT05020496
Trem-1 and Ultraviolet Radiation-induced Immune Suppression
A Early Phase 1 study testing Diphenylcyclopropenone (DPCP) in people with Skin Diseases, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The overall goal of this study is to determine novel mechanisms for ultraviolet light (UV)-induced suppression of the immune system in human subjects and to improve understanding of UV-induced skin carcinogenesis. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Diseases
- What is being tested?
- Diphenylcyclopropenone (DPCP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2022to 1 Oct 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient age 18-35
- Patient able to understand requirements of the study and risks involved
- Patient able to sign a consent form
Who cannot join
- Patients Fitzpatrick IV-VI
- A recent history of vitiligo, melasma, and other disorders of pigmentation with the exception of post inflammatory hyperpigmentation
- Patients with eczema, psoriasis, and contact dermatitis
- A known history of photosensitivity disorders
- A known history of melanoma or non-melanoma skin cancers
- Those planning on going to the tanning parlors
Show all 10Show fewer
- Using any of the photosensitizing medication
- A woman who is lactating, pregnant, or planning to become pregnant
- Patient planning on exposing the irradiated or control areas to the sun
- Patients with organ transplantation, an immunodeficiency disorder or the use of an immunosuppressive drug
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Trem-1 in Ultraviolet Radiation-induced Immune Suppression
The overall goal of this study is to determine novel mechanisms for ultraviolet light (UV)-induced suppression of the immune system in human subjects and to improve understanding of UV-induced skin carcinogenesis.
Read the detailed description
Sunlight is the major environmental agent to which the skin is exposed. Injudicious exposure to wavelengths in the ultraviolet spectrum can lead to sunburn, aging of the skin, skin cancer and a variety of photosensitivity diseases, many of which have an immunologic pathogenesis. American Cancer Society acknowledges that most skin cancers are a direct result of exposure to the ultraviolet (UV) rays in sunlight. Skin cancer has also been linked to exposure to some artificial sources of UV rays (indoor tanning, welding and metal work, and phototherapy). UV, in addition to producing mutant cells, also impairs host cell-mediated immune responses that have evolved to identify and eradicate the mutant cells before they develop into clinically apparent malignancies. In fact, organ transplant recipients who are treated with immunosuppressive medications have a greatly increased risk (up to 100 times) of UV induced skin cancers and the tumors that do develop behave more aggressively. Triggering receptor expressed on myeloid cells (Trem)-1 is highly expressed by myeloid cells in human infectious and inflammatory diseases and is associated with poor prognosis of cancer patients. However, most studies have focused on Trem1 mediated effects on innate immune cells such as neutrophils in inflammatory reactions. Little is known about whether and how Trem1 regulates the adaptive immunity, especially the activity of antigen presenting cells (APC) to regulate the activation and function of antigen specific T cells. Our study will demonstrate a novel mechanism for Trem1 signaling in T cell mediated immune responses and photocarcinogenesis in skin. Different biological parameters in UV exposed skin tissues will be analyzed, which are crucial for UV-induced DNA damage, erythema, and immune suppressive effects that have been directly associated with photoimmunology and implicated in the risk of skin cancer. These will correlated with the responsiveness of allergen induced contact hypersensitivity.
Participants will be stratified based on gender and then randomly assigned to: 1) Control 2) Non-UVB, or 3) UVB groups. The primary endpoint for the study will be the CHS evaluation on day 34.The Control group no DPCP (Group 1) will serve as a negative control while the UVB \& diphenylcyclopropenone (DPCP) group (Group 2) will serves as a positive control for measurement of response to irritant (contact hypersensitivity = CHS). Subjects in the UVB, DPCP, and Biopsy group (Group 3), who have no more than one standard deviation above the mean of CHS from the negative Control group, will be considered as Non-responders.
- Conditions
- Skin Diseases
- Being tested
- Diphenylcyclopropenone (DPCP)
- Keywords
- immune suppression
- Medical subject headings
- Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diphenylcyclopropenone (DPCP)Drug
Drug will be applied topically on the skin. It will cause contact hypersensitivity in patients
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Negative Control, 20 participants) | No intervention | At the first visit, various doses of diphenylcyclopropenone (DPCP) are applied in acetone to give the required dose range, increasing by 60% increments. Elicitation patch is applied on the upper inner arm skin and removed by patients themselves exactly 6 hours after the application. The second visit will be 48 hours after the DPCP treatment. At this visit, the bi-fold skin thickness will be measured using a Medical Skinfold Caliper. The group1 will have only one treatment with DPCP and serve as negative controls for DPCP induced cutaneous immune responses in comparison to Group 2 and 3, which require two treatments with DPCP (sensitization and challenge) as described in the following group 2 and 3. The first reading of skin thickness prior to DPCP application serves as the baseline and the second reading after DPCP indicates an increase in skin thickness, which represents a quantitative parameter of DPCP induced immune responses. |
| Group 2 (Positive Control, 20 participants) | Other | This group of the study will take approximately 5 weeks and requires 3 visits. At the first visit, skin sites on the right upper buttock will be topically treated with a patch of the contact sensitizer (DPCP) for sensitization on the upper buttock for 48 hours. The skin patches will be removed by patients themselves after the application.
The second visit will be four weeks after the DPCP sensitization, participants will have a DPCP treatment again on the right upper inner arm with the same agent. At the visit, the bi-fold skin thickness will be measured prior to the application of DPCP skin patch by using a Medical Skinfold Caliper. Various DPCP doses are applied increasing by 60% increments. The patches are applied on the upper inner arm skin and removed by patients themselves exactly 6 hours after application.
The third and final visit will be 48 hours after the second DPCP treatment. At this visit, bi-fold skin thickness will be measured using a Caliper. Receives: Drug: Diphenylcyclopropenone (DPCP) |
| Group 3 (UVB & Biopsy 30 participants) | Experimental | This group of the study will take approximately 10 weeks and requires 10 visits.
At the first visit, blood will be collected and MED will be determined. The second visit will be 24h after UV when MED will be measured. Blood will be collected from patients at this time. The third visit will be on the 8th day. The two marked skin sites will be UV exposed at 2MED on 4 consecutive days.
Days 9-11 make up the fourth, fifth, and sixth visits. Following the last UV exposure blood will be collected. A single dose of DPCP will be placed on the upper buttock for 48 hours. The seventh visit will be on the 12th day when two skin biopsies will be taken. The ninth visit will be four weeks after the sensitization with DPCP, when the upper inner arm will be treated with DPCP. Bi-fold skin thickness will be measured prior to the application of DPCP. Various DPCP doses are applied. The tenth visit will be 48 hours after the DPCP treatment. At this visit, bi-fold skin thickness will be measured. Receives: Drug: Diphenylcyclopropenone (DPCP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contact hypersensitivity
Measurement of skin bifold thickness after application of DPCP in millimeter
Measured: 24 hours after application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start21 Mar 2022
- Primary completion30 Jun 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin DiseasesStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nabiha Yusuf, University of Alabama at Birmingham
- Investigators
- Craig Elmets, MD, Study director, Univ. of Alabama at BirminghamTyler Downing, MD, Study director, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05020496
- Sponsor's protocol ID
- 300007159
- Other IDs
- R01 AI157398-01
- Status last verified
- Jul 2026
- First submitted
- 19 Jul 2021
- Last updated
- 20 Jul 2026
- 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 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Trem-1 in Ultraviolet Radiation-induced Immune Suppression
- ClinicalTrials.gov ID
- NCT05020496
- Acronym / sponsor ID
- 300007159
- Conditions
- Skin Diseases
- Keywords
- immune suppression
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 25 Aug 2021 (actual)
- 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.
The overall goal of this study is to determine novel mechanisms for ultraviolet light (UV)-induced suppression of the immune system in human subjects and to improve understanding of UV-induced skin carcinogenesis.
Detailed description
Sunlight is the major environmental agent to which the skin is exposed. Injudicious exposure to wavelengths in the ultraviolet spectrum can lead to sunburn, aging of the skin, skin cancer and a variety of photosensitivity diseases, many of which have an immunologic pathogenesis. American Cancer Society acknowledges that most skin cancers are a direct result of exposure to the ultraviolet (UV) rays in sunlight. Skin cancer has also been linked to exposure to some artificial sources of UV rays (indoor tanning, welding and metal work, and phototherapy). UV, in addition to producing mutant cells, also impairs host cell-mediated immune responses that have evolved to identify and eradicate the mutant cells before they develop into clinically apparent malignancies. In fact, organ transplant recipients who are treated with immunosuppressive medications have a greatly increased risk (up to 100 times) of UV induced skin cancers and the tumors that do develop behave more aggressively. Triggering receptor expressed on myeloid cells (Trem)-1 is highly expressed by myeloid cells in human infectious and inflammatory diseases and is associated with poor prognosis of cancer patients. However, most studies have focused on Trem1 mediated effects on innate immune cells such as neutrophils in inflammatory reactions. Little is known about whether and how Trem1 regulates the adaptive immunity, especially the activity of antigen presenting cells (APC) to regulate the activation and function of antigen specific T cells. Our study will demonstrate a novel mechanism for Trem1 signaling in T cell mediated immune responses and photocarcinogenesis in skin. Different biological parameters in UV exposed skin tissues will be analyzed, which are crucial for UV-induced DNA damage, erythema, and immune suppressive effects that have been directly associated with photoimmunology and implicated in the risk of skin cancer. These will correlated with the responsiveness of allergen induced contact hypersensitivity.
Participants will be stratified based on gender and then randomly assigned to: 1) Control 2) Non-UVB, or 3) UVB groups. The primary endpoint for the study will be the CHS evaluation on day 34.The Control group no DPCP (Group 1) will serve as a negative control while the UVB \& diphenylcyclopropenone (DPCP) group (Group 2) will serves as a positive control for measurement of response to irritant (contact hypersensitivity = CHS). Subjects in the UVB, DPCP, and Biopsy group (Group 3), who have no more than one standard deviation above the mean of CHS from the negative Control group, will be considered as Non-responders.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Negative Control, 20 participants) | No intervention | –At the first visit, various doses of diphenylcyclopropenone (DPCP) are applied in acetone to give the required dose range, increasing by 60% increments. Elicitation patch is applied on the upper inner arm skin and removed by patients themselves exactly 6 hours after the application. The second visit will be 48 hours after the DPCP treatment. At this visit, the bi-fold skin thickness will be measured using a Medical Skinfold Caliper. The group1 will have only one treatment with DPCP and serve as negative controls for DPCP induced cutaneous immune responses in comparison to Group 2 and 3, which require two treatments with DPCP (sensitization and challenge) as described in the following group 2 and 3. The first reading of skin thickness prior to DPCP application serves as the baseline and the second reading after DPCP indicates an increase in skin thickness, which represents a quantitative parameter of DPCP induced immune responses. |
| Group 2 (Positive Control, 20 participants) | Other | Drug: Diphenylcyclopropenone (DPCP)This group of the study will take approximately 5 weeks and requires 3 visits. At the first visit, skin sites on the right upper buttock will be topically treated with a patch of the contact sensitizer (DPCP) for sensitization on the upper buttock for 48 hours. The skin patches will be removed by patients themselves after the application. The second visit will be four weeks after the DPCP sensitization, participants will have a DPCP treatment again on the right upper inner arm with the same agent. At the visit, the bi-fold skin thickness will be measured prior to the application of DPCP skin patch by using a Medical Skinfold Caliper. Various DPCP doses are applied increasing by 60% increments. The patches are applied on the upper inner arm skin and removed by patients themselves exactly 6 hours after application. The third and final visit will be 48 hours after the second DPCP treatment. At this visit, bi-fold skin thickness will be measured using a Caliper. |
| Group 3 (UVB & Biopsy 30 participants) | Experimental | Drug: Diphenylcyclopropenone (DPCP)This group of the study will take approximately 10 weeks and requires 10 visits. At the first visit, blood will be collected and MED will be determined. The second visit will be 24h after UV when MED will be measured. Blood will be collected from patients at this time. The third visit will be on the 8th day. The two marked skin sites will be UV exposed at 2MED on 4 consecutive days. Days 9-11 make up the fourth, fifth, and sixth visits. Following the last UV exposure blood will be collected. A single dose of DPCP will be placed on the upper buttock for 48 hours. The seventh visit will be on the 12th day when two skin biopsies will be taken. The ninth visit will be four weeks after the sensitization with DPCP, when the upper inner arm will be treated with DPCP. Bi-fold skin thickness will be measured prior to the application of DPCP. Various DPCP doses are applied. The tenth visit will be 48 hours after the DPCP treatment. At this visit, bi-fold skin thickness will be measured. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient age 18-35
- Patient able to understand requirements of the study and risks involved
- Patient able to sign a consent form
Key exclusion criteria (10 listed)
- Patients Fitzpatrick IV-VI
- A recent history of vitiligo, melasma, and other disorders of pigmentation with the exception of post inflammatory hyperpigmentation
- Patients with eczema, psoriasis, and contact dermatitis
- A known history of photosensitivity disorders
- A known history of melanoma or non-melanoma skin cancers
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 |
|---|---|---|
| Diphenylcyclopropenone (DPCP)Drug will be applied topically on the skin. It will cause contact hypersensitivity in patients | Drug | Group 2 (Positive Control, 20 participants), Group 3 (UVB & Biopsy 30 participants) |
Primary outcome
Contact hypersensitivity
Time frame: 24 hours after application
Measurement of skin bifold thickness after application of DPCP in millimeter
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Skin Diseases
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
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.
Craig Elmets, MD study director
Univ. of Alabama at Birmingham
Tyler Downing, MD study director
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Diphenylcyclopropenone (DPCP) in people with Skin Diseases, run by University of Alabama at Birmingham 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 3 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 20 Jul 2026. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Contact hypersensitivity (time frame: 24 hours after application). 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 20 Jul 2026.