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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours after application
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am between 18 and 35 years old.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Contact hypersensitivity

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

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,565 Previous Clinical Trials
2,268,288 Total Patients Enrolled
Craig Elmets, MDStudy DirectorUniv. of Alabama at Birmingham
2 Previous Clinical Trials
24 Total Patients Enrolled
Tyler Downing, MDStudy DirectorUniversity of Alabama at Birmingham

Media Library

Diphenylcyclopropenone (DPCP) (Immunomodulator) Clinical Trial Eligibility Overview. Trial Name: NCT05020496 — Phase < 1
Skin Diseases Research Study Groups: Group 1 (Negative Control, 20 participants), Group 2 (Positive Control, 20 participants), Group 3 (UVB & Biopsy 30 participants)
Skin Diseases Clinical Trial 2023: Diphenylcyclopropenone (DPCP) Highlights & Side Effects. Trial Name: NCT05020496 — Phase < 1
Diphenylcyclopropenone (DPCP) (Immunomodulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05020496 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies for individuals to take part in the clinical trial?

"According to clinicaltrials.gov, this trial is actively seeking participants who meet the criteria set out by researchers. The study was first posted on March 21st, 2022 and has subsequently been revised as of April 14th, 2022."

Answered by AI

Is it possible for those aged 60 and above to partake in this medical experiment?

"Patients aged 18-70 are eligible to take part in this trial. Furthermore, there is an additional 14 studies available for those under the age of majority and 39 clinical trials geared towards individuals over retirement age."

Answered by AI

How many participants are participating in this experiment?

"Affirmative. According to clinicaltrials.gov, this research trial which began on March 21st 2022 is still recruiting participants and has 70 spots left open at a single facility."

Answered by AI

To whom is this experiment open for recruitment?

"This clinical trial is recruiting approximately 70 individuals aged 18-70 with skin disorders. Eligible participants must meet these criteria to be considered for the study."

Answered by AI

What past experiments have been conducted with Diphenylcyclopropenone (DPCP)?

"There are currently two active clinical trials for Diphenylcyclopropenone (DPCP), one of which is in Phase 3. Most testing is occurring within Minneapolis, Minnesota; however, there are an additional two sites researching the efficacy of this drug."

Answered by AI
~8 spots leftby Jun 2024