Botox Versus Calcipotriol in Psoriasis Vulgaris

January 2, 2024 updated by: SNIsrael, Assiut University

Efficacy and Safety of Mesobotox as a Potential New Therapeutic Modality of Psoriasis Vulgaris in Comparison/Combination With Topical Calcipotriol

Psoriasis is a systemic chronic relapsing immune-mediated disease which often requires a long-term therapy. Psoriasis occurs in around 2-3% of the total global population. In Egypt, the prevalence of psoriasis ranges between 0.19% and 3%.

Besides, it could have profound implications on the patients' psychological state and quality of life.

It is presented by erythematous, scaly plaques over the preferred sites. The pathogenesis of this highly complex disease is still far from being fully understood. Keratinocytes' hyperproliferation and immune system dysfunctions are well recognized contributors, with numerous treatments targeting these unique immunologic dysfunctions.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Neurogenic inflammation has been suggested as an etiopathogenic factor of psoriasis. Previous reports revealed an increased concentration of nerve fibers as well as a high level of neuropeptides of cutaneous sensory nerve origin, primarily Substance P and calcitonin gene-related peptide (CGRP).

Some investigators reported improvement of psoriatic plaques after injuries that compromised peripheral nerves. Hence, it was postulated that cutaneous sensory afferent neurons are involved in the etiopathogenesis of psoriasis and may serve as a potential therapeutic target.

Substance P (SP) is a neuropeptide of sensory nerve origin that can influence the immune cell functions and the inflammatory responses in psoriasis. By binding to NK1R on T cells, SP can stimulate Th17 cell differentiation and production of interleukin-17A cytokine (IL-17A). IL-17A is a key effector cytokine in psoriasis, by releasing several pro-inflammatory cytokines, such as TNF alpha, stimulating abnormal keratinocytes' proliferation and promoting angiogenesis.

Topical drug therapy is the cornerstone of the treatment of mild to moderate psoriasis. It offers a direct skin targeting and avoids systemic adverse events. Several topical therapies are currently available for the treatment of psoriasis such as topical steroids, topical vitamin D3 analogues e.g. Calcipotriol, tar, anthraline, topical calcineurin inhibitors and tazarotene.

Vitamin D exerts a number of actions in the skin as: regulation of cell proliferation & differentiation, apoptosis and immunomodulation. As a consequence of the anti-proliferative and anti-inflammatory actions of vitamin D, it can reverse the abnormal psoriatic epidermal dysfunctions. Consequently, active forms of Vitamin D as well as its analogues have proved to be effective therapeutics.

Botulinum Toxin-A (BoNT-A) is an injectable neuromodulator produced by Clostridium Botulinum, a Gram-positive bacillus that causes Botulism . The clinical utility of BoNT-A originates from the ability to block muscular contractions by inhibiting neurotransmission between peripheral nerve cells and muscle fibers. Currently, BoNT-A is widely used for multiple aesthetic concerns that can be alleviated by local muscle relaxation, such as upper facial dynamic rhytides .

Botulinum Toxin-A can inhibit the release of neurotransmitters e.g. SP from the sensory motor neurons. SP is an important neuropeptide in the pathophysiological process of cutaneous neurogenic inflammation. Thus, it was hypothesized that BoNT-A can potentially be used for treating several inflammatory skin diseases, including psoriasis .

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with clinical diagnosis of mild to moderate psoriasis vulgaris
  • Patients who stopped any systemic therapy or phototherapy for at least 3 months and topical therapy for at least 4 weeks prior to enrollment.

Exclusion Criteria:

  • • Psoriasis vulgaris involving > 10% of the body surface area, pustular or erythrodermic psoriasis.

    • Patients with neuromuscular disease or history of epilepsy.
    • Pregnant or lactating females.
    • Patients with any current dermatological disease.
    • Patients with any current systemic disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Botox group

Patients will receive a single intradermal injection of Mesobotox as a monotherapy.

Botulinum toxin injection: Botox injections will be intradermal. Concentration will be 100 U to be diluted with 5-ml sterile physiological sodium chloride solution. Each patient will receive individual injections of 1 U using a grid with points set at a distance of 1 cm apart. Up to two plaques per patient will be selected, whose diameter would not exceed 5-10 cm2. Each patient will receive a single BoNT-A injection
Drug: Botulinum Toxin-A
Botulinum Toxin-A (BoNT-A) is an injectable neuromodulator produced by Clostridium Botulinum, a Gram-positive bacillus that causes Botulism.
Experimental: Botox and calcipotriol group
Patients will receive a single intradermal injection of Mesobotox of the same dilution followed by topical application of Calcipotriol 0.005% ointment once daily for 3 months.
Drug: Botulinum Toxin-A
Botulinum Toxin-A (BoNT-A) is an injectable neuromodulator produced by Clostridium Botulinum, a Gram-positive bacillus that causes Botulism.
Drug: calcipotriol
topical vitamin D3 analogues
Experimental: calcipotriol group
Patients will apply Calcipotriol (0.005%) as a monotherapeutic control once daily for 3 months
Drug: calcipotriol
topical vitamin D3 analogues

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the efficacy and safety of Mesobotox for treatment of plaque psoriasis as a monotherapy versus its combination with a topical Calcipotriol 0.005% ointment and topical Calcipotriol 0.005% ointment alone.
Time Frame: 4 months
This will be evaluated by measuring the (Psoriasis severity (TES) score) which is a physician-based, four-point scoring system in which the thickness, erythema, and scales within each plaque will be rated from 0 (none) to 3 (severe) to evaluate the therapeutic outcome within different groups before and after treatment.
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To explore the treatment effects on the histopathological features of psoriasis.
Time Frame: 2 months
Three millimeter-punch biopsy specimens will be obtained before treatment, under local anesthesia from each patient and after 2 months of treatment. The biopsy specimens will be preserved in 10% formalin solution. Histopathological evaluation of treatment response will be performed using Hematoxylin and Eosin (H&E) stain.
2 months
To explore the treatment effects on the immunohistochemical features of psoriasis.
Time Frame: 2 months
Immunohistochemical evaluation will be done using a special stain to detect SP before and 2 months after tratment.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

December 15, 2023

First Submitted That Met QC Criteria

January 2, 2024

First Posted (Actual)

January 12, 2024

Study Record Updates

Last Update Posted (Actual)

January 12, 2024

Last Update Submitted That Met QC Criteria

January 2, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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