PsoriasisPhase 4NCT04971239
Topical Methotrexate Microemulsion in the Treatment of Plaque Psoriasis
A Phase 4 study testing topical methotrexate micoemulsion, Excimer light and Narrow band ultraviolet B in people with Psoriasis and Methotrexate, run by Assiut University.
Trial summary
Psoriasis is a chronic relapsing dermatological disease which often necessitates a long-term therapy and occurs in a significant percent of the population . It affects the skin and sometimes the nails and joints of patients . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis, Methotrexate
- What is being tested?
- topical methotrexate micoemulsion, Excimer light and Narrow band ultraviolet B
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2021to 1 Oct 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Thirty patients with mild psoriasis will be recruited from the Dermatology Outpatient Clinic, Assiut University Hospital.
- The diagnosis will be based upon the clinical characteristics of plaque psoriasis.
- Patients will be included after they have stopped any systemic therapy for at least 8 weeks and topical therapy for at least 2 weeks.
Who cannot join
- Patients having cardiovascular, renal or liver diseases.
- Patients with photosensitive or psychological disorders or immunodeficient patients.
- Pregnant or lactating woman
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Efficacy and Safety of Topical Methotrexate Microemulsion in Combination With Excimer Light and Narrow Band-ultraviolet B in the Treatment of Plaque Psoriasis
- Psoriasis is a chronic relapsing dermatological disease which often necessitates a long-term therapy and occurs in a significant percent of the population . It affects the skin and sometimes the nails and joints of patients .
- Psoriatic patients are frequently categorized into two groups: mild or moderate to severe psoriasis, depending on the clinical severity of the lesions, the percentage of affected body surface area, and patient quality of life .
- Topical drug therapy is the cornerstone in the treatment of mild to moderate psoriasis. It offers a direct targeting of affected skin by avoiding systemic adverse events .
- Several topical therapies are available for the treatment of psoriasis such as topical steroid , topical vitamin D3 analogues (calcipotriol),tar, anthraline, topical tacrolimus (a non-steroidal calcineurin inhibitor) and tazarotene (a third-generation retinoid) . However, they do not provide an adequate response owing to the inadequate percutaneous absorption and poor patient compliance caused by greasiness and stickiness of some formulations, and some patients even remain untreated .
- So that, patient satisfaction with available topical treatments remains modest .
Read the detailed description
- Methotrexate was US Food and Drug Administration approved for the treatment of psoriasis, and is currently recommended for practically all forms of moderate or severe psoriasis, including psoriatic arthritis .
- Methotrexate competitively inhibits dihydrofolate reductase enzyme which converts dihydrofolate to tetrahydrofolate (fully reduced folic acid); the latter being a necessary cofactor in the synthesis of DNA . Because systemic Methotrexate is associated with several adverse effects, topical Methotrexate has become a more-interesting alternative .
- However, the topical action of Methotrexate is challenging, since it suffers limited percutaneous diffusivity owing to its aqueous solubility, its ionization at physiological pH, and unfavorable lipid/water coefficient .
- A remedy to this problem might be the utilization of a suitable customized nano-based delivery system for enhancing the topical percutaneous penetration of MTX for treatment of psoriasis .
- Micro emulsions are among the most promising nanocarriers, being composed of aqueous and oily phases in addition to surfactants and cosurfactants . Only one study used micro emulsion as a topical nanocarrier for MTX, and jojoba oil will be selected as the oily phase of the micro emulsion since it exhibits moisturizing and anti-inflammatory effects which are beneficial in psoriasis treatment .
- The physical therapies used for the treatment of psoriasis include PUVA, broad band ultraviolet ray, Narrowband ultraviolet B and monochromatic excimer laser and light.
- Narrowband ultraviolet B (307-311 nm) showed efficacy in the treatment of psoriasis. This therapeutic approach considers that psoriasis patients undergoing phototherapy usually receive high cumulative doses of radiation during their lives, thus leading to secondary cutaneous disorders, like photoaging, telangiectasias, excessive tanning .
- On the contrary, The monochromatic excimer light device delivers ultraviolet B wavelength at 308 nm only to the lesional skin, could lower all these collateral effects dramatically and decreasing the total dose of radiation. Moreover, the treatment may be tailored to each affected area with different doses of ultraviolet makes monochromatic excimer laser and light mostly appreciated to a large part of patients, thus increasing treatment compliance, which is particularly useful when we have to deal with long-lasting therapeutic protocols.
- Finally, the possibility to focus the radiations on skin lesions is believed to reduces the risks of acute and chronic side effects in the uninvolved safe skin
- Several studies showed its effectiveness in the treatment of psoriasis as a monotherapy or in combination with several topical therapies such as flumetasone, dithranol, calcipotriol , but no study investigate its efficacy in combination with topical methotrexate yet.
- In recent years, the new biological therapies (monoclonal antibodies, receptor fusion proteins and similar) have been developed to manage psoriasis in its inner mechanisms of immune regulation. However, the legal (i.e. FDA and EMA-approved use of biologics in psoriasis) and scientific limitations (i.e. guidelines) for the use of biologics, together with the major possible medical involvements connected to this category of therapeutic agents and their expensive cost, make of them a treatment dedicated to a few well-chosen patients .
- Conditions
- Psoriasis, Methotrexate
- Being tested
- topical methotrexate micoemulsion, Excimer light, Narrow band ultraviolet B
- Keywords
- psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topical methotrexate micoemulsionDrug
Also called Methotrexate nano-emulsion
The selected microemulsion composition consists of 40% Jojoba oil, 45% Tween-80 and Span-85 at a ratio of 3:1 as surfactant and co surfactant, respectively and 15% water. The chosen concentration was based on preliminary studies conducted which delineated that these ratios provided the best skin deposition based on factorial skin modelling.The prepared microemulsions contains 0.1% methotrexate
Excimer lightDevice
the excimer laser will be done twice weekly for a total treatment course of 12 weeks.
Narrow band ultraviolet BDevice
Also called NB-UVB
the Narrow band ultraviolet B will be done twice weekly for a total treatment course of 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| topical methotrexate microemulsion | Active comparator | Group(A): topical methotrexate micro emulsion formulation, each patient will be instructed to apply a very thin film of 0.5 ml of it over the three psoriatic plaques three times weekly . Receives: Drug: topical methotrexate micoemulsion |
| combination of topical methotrexate microemulsion and excimer light | Experimental | Group(B) : excimer laser will be done twice weekly on a different psoriatic plaques in combination with topical methotrexate micro emulsion for a total treatment course of 12 weeks. Receives: Drug: topical methotrexate micoemulsion; Device: Excimer light |
| combination of topical methotrexate microemulsion and narrow band-ultraviolet B | Experimental | Group(C) : Narrow band ultraviolet B will be done twice weekly on a different psoriatic plaques in combination with topical methotrexate micro emulsion for a total treatment course of 12 weeks Receives: Drug: topical methotrexate micoemulsion; Device: Narrow band ultraviolet B |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of clinically improved patients using psoriasis severity index
clinical assessment using psoriasis severity index
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start1 Oct 2021 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies 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
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayat Mahmoud Abdelsalam, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04971239
- Sponsor's protocol ID
- MTXPSORIASIS
- Status last verified
- Jul 2021
- First submitted
- 12 Jul 2021
- Last updated
- 21 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Goff 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 25645671Mrowietz U, Kragballe K, Reich K, Spuls P, Griffiths CE, Nast A, Franke J, Antoniou C, Arenberger P, Balieva F, Bylaite M, Correia O, Dauden E, Gisondi P, Iversen L, Kemeny L, Lahfa M, Nijsten T, Rantanen T, Reich A, Rosenbach T, Segaert S, Smith C, Talme T, Volc-Platzer B, Yawalkar N. Definition of treatment goals for moderate to severe psoriasis: a European consensus. Arch Dermatol Res. 2011 Jan;303(1):1-10. doi: 10.1007/s00403-010-1080-1. Epub 2010 Sep 21.
PubMed 20857129Wollina 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 31850114Abdelgawad R, Nasr M, Moftah NH, Hamza MY. Phospholipid membrane tubulation using ceramide doping "Cerosomes": Characterization and clinical application in psoriasis treatment. Eur J Pharm Sci. 2017 Apr 1;101:258-268. doi: 10.1016/j.ejps.2017.02.030. Epub 2017 Feb 21.
PubMed 28232140Florek AG, Wang CJ, Armstrong AW. Treatment preferences and treatment satisfaction among psoriasis patients: a systematic review. Arch Dermatol Res. 2018 May;310(4):271-319. doi: 10.1007/s00403-018-1808-x. Epub 2018 Feb 13.
PubMed 29442137Carretero G, Puig L, Dehesa L, Carrascosa JM, Ribera M, Sanchez-Regana M, Dauden E, Vidal D, Alsina M, Munoz-Santos C, Lopez-Estebaranz JL, Notario J, Ferrandiz C, Vanaclocha F, Garcia-Bustinduy M, Taberner R, Belinchon I, Sanchez-Carazo J, Moreno JC; Grupo de Psoriasis de la AEDV. [Guidelines on the use of methotrexate in psoriasis]. Actas Dermosifiliogr. 2010 Sep;101(7):600-13. Spanish.
PubMed 20858386Ramez SA, Soliman MM, Fadel M, Nour El-Deen F, Nasr M, Youness ER, Aboel-Fadl DM. Novel methotrexate soft nanocarrier/fractional erbium YAG laser combination for clinical treatment of plaque psoriasis. Artif Cells Nanomed Biotechnol. 2018;46(sup1):996-1002. doi: 10.1080/21691401.2018.1440236. Epub 2018 Feb 15.
PubMed 29448838Ali MF, Salah M, Rafea M, Saleh N. Liposomal methotrexate hydrogel for treatment of localized psoriasis: preparation, characterization and laser targeting. Med Sci Monit. 2008 Dec;14(12):PI66-74.
PubMed 19043379Wong TW, Zhao YL, Sen A, Hui SW. Pilot study of topical delivery of methotrexate by electroporation. Br J Dermatol. 2005 Mar;152(3):524-30. doi: 10.1111/j.1365-2133.2005.06455.x.
PubMed 15787822Nasr M, Abdel-Hamid S, Moftah NH, Fadel M, Alyoussef AA. Jojoba Oil Soft Colloidal Nanocarrier of a Synthetic Retinoid: Preparation, Characterization and Clinical Efficacy in Psoriatic Patients. Curr Drug Deliv. 2017;14(3):426-432. doi: 10.2174/1567201813666160513132321.
PubMed 27174314Gianfaldoni S, Gianfaldoni R, Wollina U, Lotti J, Tchernev G, Lotti T. An Overview on Radiotherapy: From Its History to Its Current Applications in Dermatology. Open Access Maced J Med Sci. 2017 Jul 18;5(4):521-525. doi: 10.3889/oamjms.2017.122. eCollection 2017 Jul 25.
PubMed 28785349Mehraban S, Feily A. 308nm excimer laser in dermatology. J Lasers Med Sci. 2014 Winter;5(1):8-12.
PubMed 25606333Langley RG, Ellis CN. Evaluating psoriasis with Psoriasis Area and Severity Index, Psoriasis Global Assessment, and Lattice System Physician's Global Assessment. J Am Acad Dermatol. 2004 Oct;51(4):563-9. doi: 10.1016/j.jaad.2004.04.012.
PubMed 15389191
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Topical Methotrexate Microemulsion in Combination With Excimer Light and Narrow Band-ultraviolet B in the Treatment of Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT04971239
- Acronym / sponsor ID
- MTXPSORIASIS
- Conditions
- Psoriasis, Methotrexate
- Keywords
- psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 21 Jul 2021 (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 chronic relapsing dermatological disease which often necessitates a long-term therapy and occurs in a significant percent of the population . It affects the skin and sometimes the nails and joints of patients .
- Psoriatic patients are frequently categorized into two groups: mild or moderate to severe psoriasis, depending on the clinical severity of the lesions, the percentage of affected body surface area, and patient quality of life .
- Topical drug therapy is the cornerstone in the treatment of mild to moderate psoriasis. It offers a direct targeting of affected skin by avoiding systemic adverse events .
- Several topical therapies are available for the treatment of psoriasis such as topical steroid , topical vitamin D3 analogues (calcipotriol),tar, anthraline, topical tacrolimus (a non-steroidal calcineurin inhibitor) and tazarotene (a third-generation retinoid) . However, they do not provide an adequate response owing to the inadequate percutaneous absorption and poor patient compliance caused by greasiness and stickiness of some formulations, and some patients even remain untreated .
- So that, patient satisfaction with available topical treatments remains modest .
Detailed description
- Methotrexate was US Food and Drug Administration approved for the treatment of psoriasis, and is currently recommended for practically all forms of moderate or severe psoriasis, including psoriatic arthritis .
- Methotrexate competitively inhibits dihydrofolate reductase enzyme which converts dihydrofolate to tetrahydrofolate (fully reduced folic acid); the latter being a necessary cofactor in the synthesis of DNA . Because systemic Methotrexate is associated with several adverse effects, topical Methotrexate has become a more-interesting alternative .
- However, the topical action of Methotrexate is challenging, since it suffers limited percutaneous diffusivity owing to its aqueous solubility, its ionization at physiological pH, and unfavorable lipid/water coefficient .
- A remedy to this problem might be the utilization of a suitable customized nano-based delivery system for enhancing the topical percutaneous penetration of MTX for treatment of psoriasis .
- Micro emulsions are among the most promising nanocarriers, being composed of aqueous and oily phases in addition to surfactants and cosurfactants . Only one study used micro emulsion as a topical nanocarrier for MTX, and jojoba oil will be selected as the oily phase of the micro emulsion since it exhibits moisturizing and anti-inflammatory effects which are beneficial in psoriasis treatment .
- The physical therapies used for the treatment of psoriasis include PUVA, broad band ultraviolet ray, Narrowband ultraviolet B and monochromatic excimer laser and light.
- Narrowband ultraviolet B (307-311 nm) showed efficacy in the treatment of psoriasis. This therapeutic approach considers that psoriasis patients undergoing phototherapy usually receive high cumulative doses of radiation during their lives, thus leading to secondary cutaneous disorders, like photoaging, telangiectasias, excessive tanning .
- On the contrary, The monochromatic excimer light device delivers ultraviolet B wavelength at 308 nm only to the lesional skin, could lower all these collateral effects dramatically and decreasing the total dose of radiation. Moreover, the treatment may be tailored to each affected area with different doses of ultraviolet makes monochromatic excimer laser and light mostly appreciated to a large part of patients, thus increasing treatment compliance, which is particularly useful when we have to deal with long-lasting therapeutic protocols.
- Finally, the possibility to focus the radiations on skin lesions is believed to reduces the risks of acute and chronic side effects in the uninvolved safe skin
- Several studies showed its effectiveness in the treatment of psoriasis as a monotherapy or in combination with several topical therapies such as flumetasone, dithranol, calcipotriol , but no study investigate its efficacy in combination with topical methotrexate yet.
- In recent years, the new biological therapies (monoclonal antibodies, receptor fusion proteins and similar) have been developed to manage psoriasis in its inner mechanisms of immune regulation. However, the legal (i.e. FDA and EMA-approved use of biologics in psoriasis) and scientific limitations (i.e. guidelines) for the use of biologics, together with the major possible medical involvements connected to this category of therapeutic agents and their expensive cost, make of them a treatment dedicated to a few well-chosen patients .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| topical methotrexate microemulsion | Active comparator | Drug: topical methotrexate micoemulsionGroup(A): topical methotrexate micro emulsion formulation, each patient will be instructed to apply a very thin film of 0.5 ml of it over the three psoriatic plaques three times weekly . |
| combination of topical methotrexate microemulsion and excimer light | Experimental | Drug: topical methotrexate micoemulsion, Device: Excimer lightGroup(B) : excimer laser will be done twice weekly on a different psoriatic plaques in combination with topical methotrexate micro emulsion for a total treatment course of 12 weeks. |
| combination of topical methotrexate microemulsion and narrow band-ultraviolet B | Experimental | Drug: topical methotrexate micoemulsion, Device: Narrow band ultraviolet BGroup(C) : Narrow band ultraviolet B will be done twice weekly on a different psoriatic plaques in combination with topical methotrexate micro emulsion for a total treatment course of 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Thirty patients with mild psoriasis will be recruited from the Dermatology Outpatient Clinic, Assiut University Hospital.
- The diagnosis will be based upon the clinical characteristics of plaque psoriasis.
- Patients will be included after they have stopped any systemic therapy for at least 8 weeks and topical therapy for at least 2 weeks.
Key exclusion criteria (3 listed)
- Patients having cardiovascular, renal or liver diseases.
- Patients with photosensitive or psychological disorders or immunodeficient patients.
- Pregnant or lactating woman
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 |
|---|---|---|
| topical methotrexate micoemulsionAlso: Methotrexate nano-emulsionThe selected microemulsion composition consists of 40% Jojoba oil, 45% Tween-80 and Span-85 at a ratio of 3:1 as surfactant and co surfactant, respectively and 15% water. The chosen concentration was based on preliminary studies conducted which delineated that these ratios provided the best skin deposition based on factorial skin modelling.The prepared microemulsions contains 0.1% methotrexate | Drug | combination of topical methotrexate microemulsion and excimer light, combination of topical methotrexate microemulsion and narrow band-ultraviolet B, topical methotrexate microemulsion |
| Excimer lightthe excimer laser will be done twice weekly for a total treatment course of 12 weeks. | Device | combination of topical methotrexate microemulsion and excimer light |
| Narrow band ultraviolet BAlso: NB-UVBthe Narrow band ultraviolet B will be done twice weekly for a total treatment course of 12 weeks. | Device | combination of topical methotrexate microemulsion and narrow band-ultraviolet B |
Primary outcome
percentage of clinically improved patients using psoriasis severity index
Time frame: three months
clinical assessment using psoriasis severity index
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
- Results publication: 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.
- Results publication: PubMed 20857129Mrowietz U, Kragballe K, Reich K, Spuls P, Griffiths CE, Nast A, Franke J, Antoniou C, Arenberger P, Balieva F, Bylaite M, Correia O, Dauden E, Gisondi P, Iversen L, Kemeny L, Lahfa M, Nijsten T, Rantanen T, Reich A, Rosenbach T, Segaert S, Smith C, Talme T, Volc-Platzer B, Yawalkar N. Definition of treatment goals for moderate to severe psoriasis: a European consensus. Arch Dermatol Res. 2011 Jan;303(1):1-10. doi: 10.1007/s00403-010-1080-1. Epub 2010 Sep 21.
- Results publication: PubMed 31850114Wollina 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.
- Results publication: PubMed 28232140Abdelgawad R, Nasr M, Moftah NH, Hamza MY. Phospholipid membrane tubulation using ceramide doping "Cerosomes": Characterization and clinical application in psoriasis treatment. Eur J Pharm Sci. 2017 Apr 1;101:258-268. doi: 10.1016/j.ejps.2017.02.030. Epub 2017 Feb 21.
- Results publication: PubMed 29442137Florek AG, Wang CJ, Armstrong AW. Treatment preferences and treatment satisfaction among psoriasis patients: a systematic review. Arch Dermatol Res. 2018 May;310(4):271-319. doi: 10.1007/s00403-018-1808-x. Epub 2018 Feb 13.
- Results publication: PubMed 20858386Carretero G, Puig L, Dehesa L, Carrascosa JM, Ribera M, Sanchez-Regana M, Dauden E, Vidal D, Alsina M, Munoz-Santos C, Lopez-Estebaranz JL, Notario J, Ferrandiz C, Vanaclocha F, Garcia-Bustinduy M, Taberner R, Belinchon I, Sanchez-Carazo J, Moreno JC; Grupo de Psoriasis de la AEDV. [Guidelines on the use of methotrexate in psoriasis]. Actas Dermosifiliogr. 2010 Sep;101(7):600-13. Spanish.
- Results publication: PubMed 29448838Ramez SA, Soliman MM, Fadel M, Nour El-Deen F, Nasr M, Youness ER, Aboel-Fadl DM. Novel methotrexate soft nanocarrier/fractional erbium YAG laser combination for clinical treatment of plaque psoriasis. Artif Cells Nanomed Biotechnol. 2018;46(sup1):996-1002. doi: 10.1080/21691401.2018.1440236. Epub 2018 Feb 15.
- Results publication: PubMed 19043379Ali MF, Salah M, Rafea M, Saleh N. Liposomal methotrexate hydrogel for treatment of localized psoriasis: preparation, characterization and laser targeting. Med Sci Monit. 2008 Dec;14(12):PI66-74.
- Results publication: PubMed 15787822Wong TW, Zhao YL, Sen A, Hui SW. Pilot study of topical delivery of methotrexate by electroporation. Br J Dermatol. 2005 Mar;152(3):524-30. doi: 10.1111/j.1365-2133.2005.06455.x.
- Results publication: PubMed 27174314Nasr M, Abdel-Hamid S, Moftah NH, Fadel M, Alyoussef AA. Jojoba Oil Soft Colloidal Nanocarrier of a Synthetic Retinoid: Preparation, Characterization and Clinical Efficacy in Psoriatic Patients. Curr Drug Deliv. 2017;14(3):426-432. doi: 10.2174/1567201813666160513132321.
- Results publication: PubMed 28785349Gianfaldoni S, Gianfaldoni R, Wollina U, Lotti J, Tchernev G, Lotti T. An Overview on Radiotherapy: From Its History to Its Current Applications in Dermatology. Open Access Maced J Med Sci. 2017 Jul 18;5(4):521-525. doi: 10.3889/oamjms.2017.122. eCollection 2017 Jul 25.
- Results publication: PubMed 25606333Mehraban S, Feily A. 308nm excimer laser in dermatology. J Lasers Med Sci. 2014 Winter;5(1):8-12.
- 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 topical methotrexate micoemulsion, Excimer light and Narrow band ultraviolet B in people with Psoriasis and Methotrexate, 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 3 inclusion and 3 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 21 Jul 2021. 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 Dalia A Ahmed, professor (+201005677229, daliaattallah@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of clinically improved patients using psoriasis severity index (time frame: three 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 NCT04971239, which also lists 13 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 21 Jul 2021.