Trem-1 and Ultraviolet Radiation-induced Immune Suppression

NCT05020496 | Active Not Recruiting Early Phase 1 FDA Drug

• 2 other identifiers: 300007159R01 AI157398-01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Skin Diseases

Keywords

immune suppression

Outcome Measures

Primary Outcomes (1)

• Contact hypersensitivity

  Measurement of skin bifold thickness after application of DPCP in millimeter

  24 hours after application

Study Arms (3)

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.

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.

Drug: Diphenylcyclopropenone (DPCP)

Interventions

Diphenylcyclopropenone (DPCP) DRUG

Drug will be applied topically on the skin. It will cause contact hypersensitivity in patients

Group 2 (Positive Control, 20 participants); Group 3 (UVB & Biopsy 30 participants)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient age 18-35
• Patient able to understand requirements of the study and risks involved
• Patient able to sign a consent form

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

Whitaker Clinic

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Skin Diseases

Interventions

diphenylcyclopropenone

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Study Officials

• Craig Elmets, MD

  Univ. of Alabama at Birmingham

  STUDY DIRECTOR

• Tyler Downing, MD

  University of Alabama at Birmingham

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: August 25, 2021
• Study Start: March 21, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)