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Botox Versus Calcipotriol in Psoriasis Vulgaris

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 60 Years
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06203470
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Assiut University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Psoriasis Vulgaris
Additional Details

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 .

Arms & Interventions

Arms

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

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.

Experimental: calcipotriol group

Patients will apply Calcipotriol (0.005%) as a monotherapeutic control once daily for 3 months

Interventions

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

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Amira Ali, MD

amiraali21@yahoo.com

0201005263721

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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