Psoriasis VulgarisPhase 4NCT06203470
Botox Versus Tacrolimus in Psoriasis Vulgaris
A Phase 4 study testing Botulinum Toxin-A and Tacrolimus in people with Psoriasis Vulgaris, run by Assiut University.
Trial summary
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%. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- Botulinum Toxin-A and Tacrolimus
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jun 2024to Oct 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- • 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 locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy and Safety of Mesobotox as a Potential New Therapeutic Modality of Psoriasis Vulgaris in Comparison/Combination With Topical Calcineurin Inhibitor
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.
Read the 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.
Tacrolimus, formerly known as FK506, is a macrolide antibiotic possessing immunosuppressive properties. Tacrolimus disrupts the intracellular activation of T-lymphocytes and inhibits the ability of calcineurin to regulate gene transcription. Thus, tacrolimus intervenes at an early stage of T-cell activation, leads to several secondary consequences providing effective and therapeutically efficient results to overcome problems associated with psoriatic skin disease.
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.
- Conditions
- Psoriasis Vulgaris
- Being tested
- Botulinum Toxin-A, Tacrolimus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin-ADrug
Botulinum Toxin-A (BoNT-A) is an injectable neuromodulator produced by Clostridium Botulinum, a Gram-positive bacillus that causes Botulism.
TacrolimusDrug
topical Calcineurin inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Botox group | Experimental | 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 Receives: Drug: Botulinum Toxin-A |
| Botox and Tacrolimus group | Experimental | Patients will receive a single intradermal injection of Mesobotox of the same dilution followed by topical application of Tacrolimus 0.03% ointment twice daily for 3 months. Receives: Drug: Botulinum Toxin-A; Drug: Tacrolimus |
| Tacrolimus group | Experimental | Patients will apply Tacrolimus (0.03%) as a monotherapeutic twice daily for 3 months Receives: Drug: Tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (2)
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.
Measured: 2 months
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study startJun 2024 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Psoriasis VulgarisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SNIsrael, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06203470
- Sponsor's protocol ID
- BTP
- Status last verified
- Jun 2024
- First submitted
- 15 Dec 2023
- Last updated
- 12 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Armstrong AW, Mehta MD, Schupp CW, Gondo GC, Bell SJ, Griffiths CEM. Psoriasis Prevalence in Adults in the United States. JAMA Dermatol. 2021 Aug 1;157(8):940-946. doi: 10.1001/jamadermatol.2021.2007.
PubMed 34190957Omar SS, Helaly HA. Prevalence of ocular findings in a sample of Egyptian patients with psoriasis. Indian J Dermatol Venereol Leprol. 2018 Jan-Feb;84(1):34-38. doi: 10.4103/ijdvl.IJDVL_1239_15.
PubMed 29067934Goff KL, Karimkhani C, Boyers LN, Weinstock MA, Lott JP, Hay RJ, Coffeng LE, Norton SA, Naldi L, Dunnick C, Armstrong AW, Dellavalle RP. The global burden of psoriatic skin disease. Br J Dermatol. 2015 Jun;172(6):1665-1668. doi: 10.1111/bjd.13715. Epub 2015 May 6. No abstract available.
PubMed 25645671Khattab FM, Samir MA. Botulinum toxin type-A versus 5-fluorouracil in the treatment of plaque psoriasis: Comparative study. J Cosmet Dermatol. 2021 Oct;20(10):3128-3132. doi: 10.1111/jocd.14306. Epub 2021 Jul 14.
PubMed 34146460Kubanov AA, Katunina OR, Chikin VV. Expression of Neuropeptides, Neurotrophins, and Neurotransmitters in the Skin of Patients with Atopic Dermatitis and Psoriasis. Bull Exp Biol Med. 2015 Jul;159(3):318-22. doi: 10.1007/s10517-015-2951-4. Epub 2015 Jul 24.
PubMed 26201903Popescu MN, Beiu C, Iliescu MG, Mihai MM, Popa LG, Stanescu AMA, Berteanu M. Botulinum Toxin Use for Modulating Neuroimmune Cutaneous Activity in Psoriasis. Medicina (Kaunas). 2022 Jun 16;58(6):813. doi: 10.3390/medicina58060813.
PubMed 35744076Khattab FM. Evaluation of Botulinum Toxin A as an Optional Treatment for Atopic Dermatitis. J Clin Aesthet Dermatol. 2020 Jul;13(7):32-35. Epub 2020 Jul 1.
PubMed 32983334Gonzalez C, Franco M, Londono A, Valenzuela F. Breaking paradigms in the treatment of psoriasis: Use of botulinum toxin for the treatment of plaque psoriasis. Dermatol Ther. 2020 Nov;33(6):e14319. doi: 10.1111/dth.14319. Epub 2020 Oct 8.
PubMed 32949180Zhang Y, Zhang H, Jiang B, Yan S, Lu J. A promising therapeutic target for psoriasis: Neuropeptides in human skin. Int Immunopharmacol. 2020 Oct;87:106755. doi: 10.1016/j.intimp.2020.106755. Epub 2020 Jul 28.
PubMed 32736190Chen SQ, Chen XY, Cui YZ, Yan BX, Zhou Y, Wang ZY, Xu F, Huang YZ, Zheng YX, Man XY. Cutaneous nerve fibers participate in the progression of psoriasis by linking epidermal keratinocytes and immunocytes. Cell Mol Life Sci. 2022 Apr 30;79(5):267. doi: 10.1007/s00018-022-04299-x.
PubMed 35488965Amalia SN, Uchiyama A, Baral H, Inoue Y, Yamazaki S, Fujiwara C, Sekiguchi A, Yokoyama Y, Ogino S, Torii R, Hosoi M, Ishikawa O, Motegi SI. Suppression of neuropeptide by botulinum toxin improves imiquimod-induced psoriasis-like dermatitis via the regulation of neuroimmune system. J Dermatol Sci. 2021 Jan;101(1):58-68. doi: 10.1016/j.jdermsci.2020.11.003. Epub 2020 Nov 6.
PubMed 33176965Barros PO, Ferreira TB, Vieira MM, Almeida CR, Araujo-Lima CF, Silva-Filho RG, Hygino J, Andrade RM, Andrade AF, Bento CA. Substance P enhances Th17 phenotype in individuals with generalized anxiety disorder: an event resistant to glucocorticoid inhibition. J Clin Immunol. 2011 Feb;31(1):51-9. doi: 10.1007/s10875-010-9466-6. Epub 2010 Sep 24.
PubMed 20865305Bera MM, Lu B, Martin TR, Cui S, Rhein LM, Gerard C, Gerard NP. Th17 cytokines are critical for respiratory syncytial virus-associated airway hyperreponsiveness through regulation by complement C3a and tachykinins. J Immunol. 2011 Oct 15;187(8):4245-55. doi: 10.4049/jimmunol.1101789. Epub 2011 Sep 14.
PubMed 21918196Wollina U, Tirant M, Vojvodic A, Lotti T. Treatment of Psoriasis: Novel Approaches to Topical Delivery. Open Access Maced J Med Sci. 2019 Aug 30;7(18):3018-3025. doi: 10.3889/oamjms.2019.414. eCollection 2019 Sep 30.
PubMed 31850114Kattimani V, Tiwari RVC, Gufran K, Wasan B, Shilpa PH, Khader AA. Botulinum Toxin Application in Facial Esthetics and Recent Treatment Indications (2013-2018). J Int Soc Prev Community Dent. 2019 Mar-Apr;9(2):99-105. doi: 10.4103/jispcd.JISPCD_430_18. Epub 2019 Apr 12.
PubMed 31058058
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Mesobotox as a Potential New Therapeutic Modality of Psoriasis Vulgaris in Comparison/Combination With Topical Calcineurin Inhibitor
- ClinicalTrials.gov ID
- NCT06203470
- Acronym / sponsor ID
- BTP
- Conditions
- Psoriasis Vulgaris
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 12 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Tacrolimus, formerly known as FK506, is a macrolide antibiotic possessing immunosuppressive properties. Tacrolimus disrupts the intracellular activation of T-lymphocytes and inhibits the ability of calcineurin to regulate gene transcription. Thus, tacrolimus intervenes at an early stage of T-cell activation, leads to several secondary consequences providing effective and therapeutically efficient results to overcome problems associated with psoriatic skin disease.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Botox group | Experimental | Drug: Botulinum Toxin-APatients 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 |
| Botox and Tacrolimus group | Experimental | Drug: Botulinum Toxin-A, Drug: TacrolimusPatients will receive a single intradermal injection of Mesobotox of the same dilution followed by topical application of Tacrolimus 0.03% ointment twice daily for 3 months. |
| Tacrolimus group | Experimental | Drug: TacrolimusPatients will apply Tacrolimus (0.03%) as a monotherapeutic twice daily for 3 months |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- • Psoriasis vulgaris involving > 10% of the body surface area, pustular or erythrodermic psoriasis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum Toxin-ABotulinum Toxin-A (BoNT-A) is an injectable neuromodulator produced by Clostridium Botulinum, a Gram-positive bacillus that causes Botulism. | Drug | Botox and Tacrolimus group, Botox group |
| Tacrolimustopical Calcineurin inhibitor | Drug | Botox and Tacrolimus group, Tacrolimus group |
Primary outcome
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.
Time frame: 6 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.
2 secondary outcomes
To explore the treatment effects on the histopathological features of psoriasis.
Time frame: 2 months
To explore the treatment effects on the immunohistochemical features of psoriasis.
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Background: PubMed 34190957Armstrong AW, Mehta MD, Schupp CW, Gondo GC, Bell SJ, Griffiths CEM. Psoriasis Prevalence in Adults in the United States. JAMA Dermatol. 2021 Aug 1;157(8):940-946. doi: 10.1001/jamadermatol.2021.2007.
- Background: PubMed 29067934Omar SS, Helaly HA. Prevalence of ocular findings in a sample of Egyptian patients with psoriasis. Indian J Dermatol Venereol Leprol. 2018 Jan-Feb;84(1):34-38. doi: 10.4103/ijdvl.IJDVL_1239_15.
- Background: PubMed 25645671Goff KL, Karimkhani C, Boyers LN, Weinstock MA, Lott JP, Hay RJ, Coffeng LE, Norton SA, Naldi L, Dunnick C, Armstrong AW, Dellavalle RP. The global burden of psoriatic skin disease. Br J Dermatol. 2015 Jun;172(6):1665-1668. doi: 10.1111/bjd.13715. Epub 2015 May 6. No abstract available.
- Background: PubMed 34146460Khattab FM, Samir MA. Botulinum toxin type-A versus 5-fluorouracil in the treatment of plaque psoriasis: Comparative study. J Cosmet Dermatol. 2021 Oct;20(10):3128-3132. doi: 10.1111/jocd.14306. Epub 2021 Jul 14.
- Background: PubMed 26201903Kubanov AA, Katunina OR, Chikin VV. Expression of Neuropeptides, Neurotrophins, and Neurotransmitters in the Skin of Patients with Atopic Dermatitis and Psoriasis. Bull Exp Biol Med. 2015 Jul;159(3):318-22. doi: 10.1007/s10517-015-2951-4. Epub 2015 Jul 24.
- Background: PubMed 35744076Popescu MN, Beiu C, Iliescu MG, Mihai MM, Popa LG, Stanescu AMA, Berteanu M. Botulinum Toxin Use for Modulating Neuroimmune Cutaneous Activity in Psoriasis. Medicina (Kaunas). 2022 Jun 16;58(6):813. doi: 10.3390/medicina58060813.
- Background: PubMed 32983334Khattab FM. Evaluation of Botulinum Toxin A as an Optional Treatment for Atopic Dermatitis. J Clin Aesthet Dermatol. 2020 Jul;13(7):32-35. Epub 2020 Jul 1.
- Background: PubMed 32949180Gonzalez C, Franco M, Londono A, Valenzuela F. Breaking paradigms in the treatment of psoriasis: Use of botulinum toxin for the treatment of plaque psoriasis. Dermatol Ther. 2020 Nov;33(6):e14319. doi: 10.1111/dth.14319. Epub 2020 Oct 8.
- Background: PubMed 32736190Zhang Y, Zhang H, Jiang B, Yan S, Lu J. A promising therapeutic target for psoriasis: Neuropeptides in human skin. Int Immunopharmacol. 2020 Oct;87:106755. doi: 10.1016/j.intimp.2020.106755. Epub 2020 Jul 28.
- Background: PubMed 35488965Chen SQ, Chen XY, Cui YZ, Yan BX, Zhou Y, Wang ZY, Xu F, Huang YZ, Zheng YX, Man XY. Cutaneous nerve fibers participate in the progression of psoriasis by linking epidermal keratinocytes and immunocytes. Cell Mol Life Sci. 2022 Apr 30;79(5):267. doi: 10.1007/s00018-022-04299-x.
- Background: PubMed 33176965Amalia SN, Uchiyama A, Baral H, Inoue Y, Yamazaki S, Fujiwara C, Sekiguchi A, Yokoyama Y, Ogino S, Torii R, Hosoi M, Ishikawa O, Motegi SI. Suppression of neuropeptide by botulinum toxin improves imiquimod-induced psoriasis-like dermatitis via the regulation of neuroimmune system. J Dermatol Sci. 2021 Jan;101(1):58-68. doi: 10.1016/j.jdermsci.2020.11.003. Epub 2020 Nov 6.
- Background: PubMed 20865305Barros PO, Ferreira TB, Vieira MM, Almeida CR, Araujo-Lima CF, Silva-Filho RG, Hygino J, Andrade RM, Andrade AF, Bento CA. Substance P enhances Th17 phenotype in individuals with generalized anxiety disorder: an event resistant to glucocorticoid inhibition. J Clin Immunol. 2011 Feb;31(1):51-9. doi: 10.1007/s10875-010-9466-6. Epub 2010 Sep 24.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Botulinum Toxin-A and Tacrolimus in people with Psoriasis Vulgaris, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amira Ali, MD (0201005263721, amiraali21@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06203470, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2024.