Botox for Eczema

(AD Trial)

Recruiting at 1 trial location

Overseen By Anna Davis, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Daniel Kaplan

Must not be taking: Biologics, Systemic non-biologics

Disqualifiers: Pregnancy, Breastfeeding, Heart failure, others

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

Compensation: Varies

Number of Visits: 6

8 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how Botox (Onabotulinum Toxin Type A) can alter skin interactions in individuals with mild-to-moderate eczema. The goal is to determine if Botox injections into skin patches can improve eczema. The trial consists of two parts: one where Botox is administered to two skin spots and another where it is given to three. Participants should have mild-to-moderate eczema and not have recently used strong eczema treatments. Those with a history of eczema who have not used specific treatments recently may be suitable candidates. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative treatment.

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications. You cannot have used systemic therapy for 3 months or topical therapy for eczema for 4 weeks before joining the trial.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

A previous study found that Botox (onabotulinum toxin type A) is safe for treating skin conditions like eczema. Research shows it can help with symptoms such as itching and inflammation. Another study showed that patients with Hailey-Hailey disease used Botox and experienced only mild side effects.

Since this trial is in its early stages, the main goal is to assess the safety of Botox for eczema. Early trials focus on safety, identifying any serious side effects before proceeding further. However, the FDA has already approved Botox for other uses, indicating a proven safety record and general tolerance among people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for eczema?

Most treatments for eczema rely on topical steroids or immunosuppressants, which can have long-term side effects and don't always provide quick relief. But Onabotulinum Toxin Type A, commonly known as Botox, offers a different approach. Researchers are excited because Botox works by temporarily blocking nerve signals, which can reduce inflammation and itchiness in the skin. This mechanism is distinct from the typical methods used for eczema, potentially providing faster and more targeted relief. Additionally, the use of Botox in dermatology could broaden treatment options for patients who haven’t responded well to conventional therapies.

What evidence suggests that Onabotulinum Toxin Type A might be an effective treatment for eczema?

Research has shown that Botox, or Onabotulinum Toxin Type A, a treatment often used for other conditions, might help with eczema by affecting nerve signals in the skin. Previous studies found that Botox reduces inflammation and itching, common symptoms of eczema, by blocking certain nerve signals. Although data specifically for eczema is limited, Botox is already used successfully for other nerve-related issues, such as chronic migraines. Early results suggest it might calm the overactive nerves contributing to eczema, potentially providing relief for patients. In this trial, participants will receive Onabotulinum Toxin Type A administered to either two or three lesions, depending on the study phase.

Who Is on the Research Team?

Daniel Kaplan, MD, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

Adults over 18 with mild-to-moderate Atopic Dermatitis (AD) can join this trial. They should have a patch of eczema at least 5 cm wide but no more than 10% body surface area affected. Participants must not have used biologics, systemic treatments for AD in the last 3 months, or topical treatments in the last 4 weeks.

Inclusion Criteria

I am 18+, have mild-to-moderate AD with limited body coverage, and haven't used certain AD treatments recently.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1a

Pilot run of spatial single cell imaging performed on normal skin and with atopic dermatitis

4 weeks

1 visit (in-person)

Phase 1b

Intradermal botulinum toxin administered to AD lesions to determine the kinetics of the clinical response

4 weeks

2 visits (in-person)

Phase 2

Botulinum toxin therapy to test alteration of cellular and molecular state of AD lesions

4 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Onabotulinum Toxin Type A

Trial Overview The study is testing Onabotulinum Toxin Type A's effect on skin interactions in two phases: Phase 1b and Phase 2. It aims to understand how this toxin changes cellular and molecular dynamics in AD-affected skin.

How Is the Trial Designed?

Group I: Onabotulinum Toxin Type A - Phase 2 Experimental Treatment 1 Intervention

Onabotulinum toxin administered to three lesions.

Group II: Onabotulinum Toxin Type A - Phase 1b Experimental Treatment 1 Intervention

Onabotulinum toxin administered to two lesions.

Who Is Running the Clinical Trial?

Daniel Kaplan

Lead Sponsor

Almirall, S.A.

Industry Sponsor

Trials

63

Recruited

19,200+

Carlos Gallardo Piqué

Almirall, S.A.

Chief Executive Officer since 2023

MS in Industrial Engineering from Universitat Politècnica de Catalunya, MBA from Stanford Graduate School of Business

Mercedes Diz

Almirall, S.A.

Chief Medical Officer since 2023

PhD in Biochemistry

Published Research Related to This Trial

In two studies involving 631 adults with moderate to severe atopic dermatitis, tacrolimus ointment (0.03% or 0.1%) was found to be effective, significantly outperforming the vehicle in all measured efficacy parameters over 12 weeks.

While some patients experienced mild adverse events like skin burning and pruritus, these were generally brief and resolved quickly; importantly, tacrolimus ointment was deemed safe, with no significant laboratory changes and low systemic absorption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tacrolimus ointment for the treatment of atopic dermatitis in adult patients: part II, safety. Soter, NA., Fleischer, AB., Webster, GF., et al.[2022]

Topical corticosteroids (TCS) used for atopic eczema showed no significant increased risk of skin thinning in short-term studies, indicating they are generally safe for use in both adults and children.

While TCS may have a higher relative risk of skin thinning compared to topical calcineurin inhibitors, the overall long-term safety data is limited, suggesting that intermittent use of TCS is safe but requires further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of topical corticosteroids in atopic eczema: an umbrella review. Axon, E., Chalmers, JR., Santer, M., et al.[2023]

OnabotulinumtoxinA is generally considered safe and effective for both cosmetic and medical treatments, with minimal adverse events reported.

A case study is presented where a patient experienced neuropathic pruritus five days after receiving onabotulinumtoxinA for neuromuscular pain, emphasizing the need for awareness and management of this potential side effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pruritus associated with onabotulinumtoxinA treatment of neuromuscular pain. Ho, D., Jagdeo, J.[2018]

Chronic hand/foot eczema treatment is complex and requires a comprehensive approach that includes identifying irritants, patch testing, and discussing individual treatment goals with patients, focusing on restoring function as the primary aim.

For moderately symptomatic patients, starting with potent topical corticosteroids is recommended, and if ineffective, options like phototherapy or systemic treatments such as methotrexate or ciclosporin can be considered, while severe cases may require short-term systemic corticosteroids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of chronic hand and foot eczema. An Australia/New Zealand Clinical narrative. Rademaker, M., Armour, K., Baker, C., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7492021/

Evaluation of Botulinum Toxin A as an Optional Treatment ... OBJECTIVE: Botulinum toxin (BTX) A has different biological activities, including anti-inflammatory and antipruritic behavior.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06928246

The Impact of Botox on Neuroimmune Interactions in Atopic ... The purpose of this study is to understand cellular and molecular interactions in the skin of participants with mild-to-moderate AD, and how botulinum toxin ...

3. jddonline.com jddonline.com/articles/double-blind-placebo-controlled-study-of-onabotulinumtoxin-a-for-the-treatment-of-hailey-hailey-disease-S1545961623P0339X

Double-Blind, Placebo-Controlled Study of ... Objective: The goal of this study was to evaluate the safety and efficacy of onabotulinumtoxin A for the treatment of HHD. ... Atopic ...

4. withpower.com withpower.com/trial/phase-1-dermatitis-6-2025-fe5c4

Botox for Eczema (AD Trial) - Atopic Dermatitis Research shows that Onabotulinum Toxin Type A can be effective in treating chronic dry palmar eczema, providing longer-lasting relief and higher patient ...

5. mdpi.com mdpi.com/2072-6651/9/12/403

Botulinum Toxin in the Field of Dermatology: Novel ... Botulinum toxin type a inhibits alpha-smooth muscle actin and myosin ii expression in fibroblasts derived from scar contracture. Ann. Plast. Surg. 2016, 77 ...