Botox for Eczema

(AD Trial)

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

Trial Summary

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.

What data supports the effectiveness of the drug Onabotulinum Toxin Type A for treating eczema?

Research shows that Onabotulinum Toxin Type A can be effective in treating chronic dry palmar eczema, providing longer-lasting relief and higher patient satisfaction compared to traditional treatments like steroids and moisturizers. ^{1 2 3 4 5}

Is Botox safe for treating eczema?

Botox (Onabotulinum Toxin Type A) appears to be safe for treating eczema, as studies have shown it to be effective and well-tolerated in patients with atopic dermatitis, with no significant safety concerns reported. ^{6 7 8 9 10}

How does the drug Onabotulinum Toxin Type A differ from other eczema treatments?

Onabotulinum Toxin Type A, commonly known as Botox, is unique for eczema treatment because it works by blocking nerve signals that can trigger excessive sweating, which may help in cases of dyshidrotic eczema (a type of eczema that causes blisters on the hands and feet). This is different from traditional treatments like topical corticosteroids or UV therapy, which focus on reducing inflammation and skin cell turnover. ^{11 12 13 14 15}

What is the purpose of this trial?

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 alters these interactions.

Research Team

Daniel Kaplan, MD, PhD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Pruritus associated with onabotulinumtoxinA treatment of neuromuscular pain. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Neurotoxins: Evidence for Prevention. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Botulinum toxin type A in chronic non-dyshidrotic palmar eczema: A side-by-side comparative study. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Treatment of dyshidrotic hand dermatitis with intradermal botulinum toxin. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Beyond Muscle: A Narrative Review of Onabotulinum Toxin A for Skin Quality. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Evaluation of Botulinum Toxin A as an Optional Treatment for Atopic Dermatitis. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Safety of topical corticosteroids in atopic eczema: an umbrella review. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Corticosteroid exposure and cumulative effects in patients with eczema: Results from a patient survey. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Tacrolimus ointment for the treatment of atopic dermatitis in adult patients: part II, safety. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Eczema as an adverse effect of anti-TNFα therapy in psoriasis and other Th1-mediated diseases: a review. [2018]

11. Canada pubmed.ncbi.nlm.nih.gov

Treatment of hand eczema. [2004]

12. England pubmed.ncbi.nlm.nih.gov

Medium-dose ultraviolet (UV) A1 vs. narrowband UVB phototherapy in atopic eczema: a randomized crossover study. [2009]

13. Australia pubmed.ncbi.nlm.nih.gov

Atopic eczema of adult type in Japan. [2019]

14. Germany pubmed.ncbi.nlm.nih.gov

[Ultraviolet therapy in patients with chronic hand eczema]. [2021]

15. Australia pubmed.ncbi.nlm.nih.gov

Management of chronic hand and foot eczema. An Australia/New Zealand Clinical narrative. [2021]