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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how diphenylcyclopropenone (DPCP) affects the immune system when combined with ultraviolet (UV) light exposure. The goal is to better understand how UV light might lead to skin cancer. The study includes three groups: one receives DPCP alone, another combines it with UV exposure, and a third serves as a control for comparison. Researchers seek participants without skin conditions like eczema, a history of skin cancer, or light sensitivity. This trial may suit those without recent skin issues who do not plan to tan or spend excessive time in the sun. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking research.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using any photosensitizing medications (drugs that make your skin more sensitive to light) or immunosuppressive drugs (medications that weaken the immune system).

Is there any evidence suggesting that Diphenylcyclopropenone (DPCP) is likely to be safe for humans?

Previous studies have shown that diphenylcyclopropenone (DPCP) can cause mild to severe skin irritation, known as contact dermatitis. This irritation can make the skin red, itchy, or even blistered. One study found that about 36% of participants had mild skin reactions, while 31% experienced more severe reactions. Other side effects included swollen lymph nodes in 22% of participants and skin darkening in 22%. These reactions are usually expected and indicate that the treatment is working. DPCP is often used to treat conditions like alopecia areata (a type of hair loss), though the FDA has not approved it for this use. Safety data from these treatments suggest that while skin reactions are common, they are generally manageable. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about using diphenylcyclopropenone (DPCP) for skin diseases because it offers a novel approach to activating the immune system in a targeted way. Unlike standard treatments like corticosteroids or immunosuppressants, which can broadly suppress immune function, DPCP works by sensitizing the skin to provoke a localized immune response. This method could lead to more precise treatments with fewer systemic side effects. Additionally, DPCP’s unique application as a topical sensitizer might offer a new pathway for treating conditions like alopecia areata or warts, potentially providing quicker and more targeted results.

What evidence suggests that this trial's treatments could be effective for skin diseases?

Research has shown that diphenylcyclopropenone (DPCP) can help treat alopecia areata, a condition that causes hair loss. One study found that 71% of individuals with alopecia totalis (complete hair loss on the scalp) and 56% with alopecia universalis (complete hair loss on the body) experienced significant hair regrowth. Overall, about 55% of people respond to DPCP treatment. While DPCP may not work for everyone, it offers hope for those experiencing different types of hair loss. The treatment is generally safe, with side effects that most people can manage. In this trial, researchers will divide participants into different groups to study the effects of DPCP under various conditions, including as a negative control, a positive control, and in combination with UVB exposure and biopsy. ^{1 2 4 6 7}

Who Is on the Research Team?

Tyler Downing, MD

Principal Investigator

University of Alabama at Birmingham

Craig Elmets, MD

Principal Investigator

Univ. of Alabama at Birmingham

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6320486/

Efficacy of diphenylcyclopropenone in alopecia areata In the present study, the efficacy of DPCP was confirmed in patients with different severities of AA. Additionally, treatment at longer intervals (21 days vs. 7 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03651752?cond=Alopecia%20Areata&aggFilters=phase:1%202%203%204,status:not%20rec%20enr%20act&rank=8

NCT03651752 | DPCP for the Treatment of Alopecia Areata This is an open labeled study to determine the response and characteristics, safety and efficacy, of the proprietary DPCP ointment composition as a topical ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1087002416300284

Clinical Efficacy of Diphenylcyclopropenone in Alopecia ... In our study, treatment success, defined as ≥50% terminal hair regrowth, was reached in 71% of alopecia totalis patients and in 56% of alopecia universalis ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1155/2023/6073889

The Efficacy, Safety, and Recurrence Rate of ... Diphenylcyclopropenone topical immunotherapy is an effective treatment for various types of alopecia areata, and most of its common side effects are acceptable.

5. dermnetnz.org dermnetnz.org/topics/diphenylcyclopropenone

Diphenylcyclopropenone, diphencyprone The overall response rate in that study was 55%. Diphenylcyclopropenone is not effective for everyone. A response is more likely in those who have had alopecia ...

6. downloads.regulations.gov downloads.regulations.gov/FDA-2018-N-3240-0064/content.pdf

Clinical need for diphenylcyclopropenone (DPCP) in ... DPCP, OND has reviewed safety issues raised by use of this substance in compounding and available evidence of effectiveness or lack of ...

7. jamanetwork.com jamanetwork.com/journals/jamadermatology/fullarticle/1359490

The Safety and Efficacy of Diphencyprone for ... Topical diphencyprone (DPCP) immunotherapy is used to treat refractory and advanced alopecia areata. Although not approved for this indication by the US.