DPCP for Skin Diseases

Overseen By Hui Xu, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Alabama at Birmingham

Must not be taking: Photosensitizing, Immunosuppressive

Disqualifiers: Photosensitivity, Skin cancers, Eczema, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 5-10 weeks

70 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Craig Elmets, MD

Principal Investigator

Univ. of Alabama at Birmingham

Tyler Downing, MD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

This trial is for individuals aged 18-35 who understand the study's requirements and risks, and can consent to participate. It excludes those with certain skin pigment disorders, a history of skin cancer or photosensitivity, high sun exposure risk including tanning parlors, darker skin types (Fitzpatrick IV-VI), immune system conditions or drug use affecting immunity, and women who are pregnant or lactating.

Inclusion Criteria

Patient able to sign a consent form

I understand what participating in the study involves and its risks.

Exclusion Criteria

I have had an organ transplant, have an immune disorder, or am taking immunosuppressive medication.

A woman who is lactating, pregnant, or planning to become pregnant

A known history of photosensitivity disorders

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are stratified into Control, Non-UVB, or UVB groups and receive treatments with DPCP and/or UVB exposure

5-10 weeks

3-10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including measurement of skin bifold thickness

4 weeks

Treatment Details

Interventions

• Diphenylcyclopropenone (DPCP)

Trial Overview The study aims to explore how ultraviolet light (UV) suppresses the immune system which may affect skin cancer development. Participants will be treated with Diphenylcyclopropenone (DPCP), a substance used in immunotherapy for dermatological purposes.

Participant Groups

Group I: Group 3 (UVB & Biopsy 30 participants) Experimental Treatment 1 Intervention

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.

Group II: Group 2 (Positive Control, 20 participants) Experimental Treatment 1 Intervention

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 III: Group 1 (Negative Control, 20 participants) Active Control 1 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.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+