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Immunomodulator

DPCP for Skin Diseases

Phase < 1

Waitlist Available

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient age 18-35

Be older than 18 years old

Must not have

Patients with organ transplantation, an immunodeficiency disorder or the use of an immunosuppressive drug

Patient planning on exposing the irradiated or control areas to the sun

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours after application

Awards & highlights

No Placebo-Only Group

Summary

This trial will study how UV light affects the immune system and causes skin cancer.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects of DPCP in this context aren't detailed here, generally it can cause local skin reactions like redness, itching or blistering where applied. Systemic side effects are rare but could include flu-like symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 35 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I plan to expose treated skin areas to the sun.

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I have a history of skin cancer.

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I am currently taking medication that increases my sensitivity to light.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours after application

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 hours after application

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours after application for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Contact hypersensitivity

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Group 3 (UVB & Biopsy 30 participants)Experimental Treatment1 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 Treatment1 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 Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Diphenylcyclopropenone (DPCP)

2012

Completed Phase 1

~10

0 / 5Eligibility criteria met