Health TrialsbyHealthPanel

Botox Versus Tacrolimus in Psoriasis Vulgaris

ConditionPsoriasis Vulgaris
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-60
SponsorAssiut University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

• 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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Botulinum Toxin-A

    Drug

    Botulinum Toxin-A (BoNT-A) is an injectable neuromodulator produced by Clostridium Botulinum, a Gram-positive bacillus that causes Botulism.

  • Tacrolimus

    Drug

    topical Calcineurin inhibitor

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Botox groupExperimental treatment 1 intervention
Group B: Botox and Tacrolimus groupExperimental treatment 2 interventions
Group C: Tacrolimus groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

To evaluate the efficacy and safety of Mesobotox for treatment of plaque psoriasis as a monotherapy versus its combination with a topical Calcineurin inhibitor 0.03% ointment and topical Calcineurin inhibitor 0.03% ointment alone.

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.

Time frame
6 months

Secondary outcomes

1

To explore the treatment effects on the histopathological features of psoriasis.

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.

Time frame
2 months
2

To explore the treatment effects on the immunohistochemical features of psoriasis.

Immunohistochemical evaluation will be done using a special stain to detect SP before and 2 months after tratment.

Time frame
2 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: