PsoriasisPhase 4NCT05555797
Excimer Laser With Topical Agents in Psoriasis Vulgaris
A Phase 4 study testing 308nm Excimer laser, Tazarotene Topical Gel and Betamethasone Valerate in people with Psoriasis, run by Assiut University.
Trial summary
Psoriasis is a chronic, immune-mediated disease that affects approximately 2% of the population. The development and exacerbation of psoriasis involve an interaction between multiple genetic and environmental risk factors. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- 308nm Excimer laser, Tazarotene Topical Gel and Betamethasone Valerate
- 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
- 30 Oct 2022to 30 Sep 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: ≥18 years.
- Pattern: Patients with chronic plaque psoriasis not exceeding 10% of the body surface area.
Who cannot join
- History of retinoid use either topical or systemic in the previous 16 weeks, phototherapy or topical psoriasis treatment within the last 4 weeks.
- Allergy to any ingredients of tretinoin or betamethasone drugs.
- Renal, hepatic disease, cardiovascular , Immunosuppressive therapy, endocrine and blood disease or mental illness.
- Pregnancy, breast-feeding or women planning to become pregnant within 3 months.
- Psoriasis exceeding 10% of body surface area or other severe types of psoriasis requiring systemic treatment.
- Patients with other diseases and requiring treatment that would affect the study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy of Excimer Laser Combined With Either Topical Tazarotene or Topical Betamethasone Valerate Versus Excimer Laser Alone in Treatment of Localized Chronic Plaque Psoriasis; Clinical and Dermoscopic Study
Psoriasis is a chronic, immune-mediated disease that affects approximately 2% of the population. The development and exacerbation of psoriasis involve an interaction between multiple genetic and environmental risk factors.
Read the detailed description
Psoriasis presents as well-circumscribed, erythematous plaques with an overlying silvery white scales. It has an effect on various aspects of life including mental health, productivity and relationships.
Topical therapies as corticosteroids and vitamin D3 analogs are first-line treatments for mild plaque psoriasis; which involves less than 3% of the body surface area (BSA). Moderate-to-severe plaque psoriasis is usually managed with phototherapy, systemic or biologic therapies .
The American Academy of Dermatology gives a strength recommendation for the use of combination therapies for treatment of psoriasis with superior efficacy to monotherapy .
The 308-nm excimer laser has been widely used for many dermatological diseases. In psoriasis, it shows an efficacy in the treatment of localised plaques especially on the knees and elbows.
It is indicated in moderate to severe psoriasis that affects <10% of the body surface. Areas such as nose, ears and palpebral region can be easily accessed using the laser. It induces lymphocytic apoptosis and decreases the proliferation rate of keratinocytes . There are multiple protocols that evaluate the clinical response to Excimer laser; the induration protocol, the minimal erythema dose and the minimal blistering dose.
The induration protocol compared with the others, allows to modify the dose with treatment. With this protocol, plaques achieved Psoriasis area and severity index (PASI-75) after 10 treatments .
Tazarotene (TAZ) is a topical retinoid with retinoic acid receptor β / γ receptor specificity. It has been shown to be effective for psoriasis treatment. However, its topical application is limited by its irritation.
Studies have shown that combination with other lines may optimize the efficacy as well as minimize the local irritation due to TAZ.
Betamethasone valerate (BV) is a high-potency, synthetic corticosteroid which acts on the intracellular glucocorticoid receptor.
It also binds to membrane-bound receptors, enhancing its action. BV suppresses the production of inflammatory cytokines and reduces keratinocyte hyperproliferation.
- Conditions
- Psoriasis
- Being tested
- 308nm Excimer laser, Tazarotene Topical Gel, Betamethasone Valerate
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
308nm Excimer laserDevice
Excimer laser will be (1-2 sessions/ week for 12 sessions according to induration protocol)
Tazarotene Topical GelDrug
Tazarotene gel 0.1%(finger tip unit of the gel) will be applied once daily for weeks
Betamethasone ValerateDrug
.Betamethasone valerate ointment 0.1% will be applied twice daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| group of patients with psoriasis vulgaris | Experimental | in each patient lesions will be divided into 3 groups; Group 1: treated with Excimer laser alone(1-2 sessions/ week for 12 sessions according to induration protocol*).
Group 2: treated with Excimer laser combined with topical tazarotene gel 0.1% Group3: treated with Excimer laser combined with topical betamethasone valerate ointment 0.1% Receives: Device: 308nm Excimer laser; Drug: Tazarotene Topical Gel; Drug: Betamethasone Valerate |
What is being measured
The primary outcome is the main question the study is designed to answer.
detection of improvement of psoriasis
detection of improvement of psoriasis in response to excimer laser alone versus its combination with either topical tazarotene gel or betamethasone valerate ointment
Measured: 3 months
Secondary outcomes (1)
dermoscopic role
detection the role of the dermoscope in monitoring the response to treatment of psoriasis by excimer laser alone versus its combination with either topical tazarotene gel or betamethasone valerate ointment.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start30 Oct 2022 (estimated)
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)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
- Not applicable
- Intervention model
- Single group
- 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, Aliaa Effat Saied Sayed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05555797
- Sponsor's protocol ID
- EXCTBVPS
- Status last verified
- Oct 2022
- First submitted
- 17 Sep 2022
- Last updated
- 18 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Abrouk M, Levin E, Brodsky M, Gandy JR, Nakamura M, Zhu TH, Farahnik B, Koo J, Bhutani T. Excimer laser for the treatment of psoriasis: safety, efficacy, and patient acceptability. Psoriasis (Auckl). 2016 Dec 12;6:165-173. doi: 10.2147/PTT.S105047. eCollection 2016.
PubMed 29387603Ardeleanu V, Sabina Radaschin D, Tatu AL. Excimer laser for psoriasis treatment: A case report and short review. Exp Ther Med. 2020 Jul;20(1):52-55. doi: 10.3892/etm.2020.8529. Epub 2020 Feb 14.
PubMed 32508993He C, Jin H, Liu X, Hu F, Zhang L, Zhang S, He Y, Yang X, Chen H, Wang X, Ji C, Lv C, Miao G, Li X, Diao Q, Li L, Li X, Li Y, Wang R, Zhang L, Zhou X, Xia X, Yan M, Song J, Zhang R, Geng L, Zheng M, Lu Q, Lu T, Shi Y, Jing H, Zhang X, Shi J, Xia J, Gao Y, Wang Y. Tazarotene/Betamethasone Dipropionate Cream in Patients with Plaque Psoriasis: Results of a Prospective, Multicenter, Observational Study. Dermatology. 2021;237(4):603-610. doi: 10.1159/000511891. Epub 2020 Dec 22.
PubMed 33352561Elmets CA, Korman NJ, Prater EF, Wong EB, Rupani RN, Kivelevitch D, Armstrong AW, Connor C, Cordoro KM, Davis DMR, Elewski BE, Gelfand JM, Gordon KB, Gottlieb AB, Kaplan DH, Kavanaugh A, Kiselica M, Kroshinsky D, Lebwohl M, Leonardi CL, Lichten J, Lim HW, Mehta NN, Paller AS, Parra SL, Pathy AL, Siegel M, Stoff B, Strober B, Wu JJ, Hariharan V, Menter A. Joint AAD-NPF Guidelines of care for the management and treatment of psoriasis with topical therapy and alternative medicine modalities for psoriasis severity measures. J Am Acad Dermatol. 2021 Feb;84(2):432-470. doi: 10.1016/j.jaad.2020.07.087. Epub 2020 Jul 30.
PubMed 32738429Nestor MS, Fischer D, Arnold D. Randomized, Investigator-Blinded Study to Compare the Efficacy and Tolerance of a 650-microsecond, 1064-nm YAG Laser to a 308-nm Excimer Laser for the Treatment of Mild to Moderate Psoriasis Vulgaris. J Drugs Dermatol. 2020 Feb 1;19(2):176-183. doi: 10.36849/JDD.2020.4769.
PubMed 32129962Langley 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 15389191Ramez 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 29448838Taneja A, Trehan M, Taylor CR. 308-nm excimer laser for the treatment of psoriasis: induration-based dosimetry. Arch Dermatol. 2003 Jun;139(6):759-64. doi: 10.1001/archderm.139.6.759.
PubMed 12810507Naldi L, Yawalkar N, Kaszuba A, Ortonne JP, Morelli P, Rovati S, Mautone G. Efficacy and safety of the Betamethasone valerate 0.1% plaster in mild-to-moderate chronic plaque psoriasis: a randomized, parallel-group, active-controlled, phase III study. Am J Clin Dermatol. 2011 Jun 1;12(3):191-201. doi: 10.2165/11539780-000000000-00000.
PubMed 21284407
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Excimer Laser Combined With Either Topical Tazarotene or Topical Betamethasone Valerate Versus Excimer Laser Alone in Treatment of Localized Chronic Plaque Psoriasis; Clinical and Dermoscopic Study
- ClinicalTrials.gov ID
- NCT05555797
- Acronym / sponsor ID
- EXCTBVPS
- Conditions
- Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Oct 2022 (estimated)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 27 Sep 2022 (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, immune-mediated disease that affects approximately 2% of the population. The development and exacerbation of psoriasis involve an interaction between multiple genetic and environmental risk factors.
Detailed description
Psoriasis presents as well-circumscribed, erythematous plaques with an overlying silvery white scales. It has an effect on various aspects of life including mental health, productivity and relationships.
Topical therapies as corticosteroids and vitamin D3 analogs are first-line treatments for mild plaque psoriasis; which involves less than 3% of the body surface area (BSA). Moderate-to-severe plaque psoriasis is usually managed with phototherapy, systemic or biologic therapies .
The American Academy of Dermatology gives a strength recommendation for the use of combination therapies for treatment of psoriasis with superior efficacy to monotherapy .
The 308-nm excimer laser has been widely used for many dermatological diseases. In psoriasis, it shows an efficacy in the treatment of localised plaques especially on the knees and elbows.
It is indicated in moderate to severe psoriasis that affects <10% of the body surface. Areas such as nose, ears and palpebral region can be easily accessed using the laser. It induces lymphocytic apoptosis and decreases the proliferation rate of keratinocytes . There are multiple protocols that evaluate the clinical response to Excimer laser; the induration protocol, the minimal erythema dose and the minimal blistering dose.
The induration protocol compared with the others, allows to modify the dose with treatment. With this protocol, plaques achieved Psoriasis area and severity index (PASI-75) after 10 treatments .
Tazarotene (TAZ) is a topical retinoid with retinoic acid receptor β / γ receptor specificity. It has been shown to be effective for psoriasis treatment. However, its topical application is limited by its irritation.
Studies have shown that combination with other lines may optimize the efficacy as well as minimize the local irritation due to TAZ.
Betamethasone valerate (BV) is a high-potency, synthetic corticosteroid which acts on the intracellular glucocorticoid receptor.
It also binds to membrane-bound receptors, enhancing its action. BV suppresses the production of inflammatory cytokines and reduces keratinocyte hyperproliferation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| group of patients with psoriasis vulgaris | Experimental | Device: 308nm Excimer laser, Drug: Tazarotene Topical Gel, Drug: Betamethasone Valeratein each patient lesions will be divided into 3 groups; Group 1: treated with Excimer laser alone(1-2 sessions/ week for 12 sessions according to induration protocol*). Group 2: treated with Excimer laser combined with topical tazarotene gel 0.1% Group3: treated with Excimer laser combined with topical betamethasone valerate ointment 0.1% |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age: ≥18 years.
- Pattern: Patients with chronic plaque psoriasis not exceeding 10% of the body surface area.
Key exclusion criteria (6 listed)
- History of retinoid use either topical or systemic in the previous 16 weeks, phototherapy or topical psoriasis treatment within the last 4 weeks.
- Allergy to any ingredients of tretinoin or betamethasone drugs.
- Renal, hepatic disease, cardiovascular , Immunosuppressive therapy, endocrine and blood disease or mental illness.
- Pregnancy, breast-feeding or women planning to become pregnant within 3 months.
- Psoriasis exceeding 10% of body surface area or other severe types of psoriasis requiring systemic treatment.
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 |
|---|---|---|
| 308nm Excimer laserExcimer laser will be (1-2 sessions/ week for 12 sessions according to induration protocol) | Device | group of patients with psoriasis vulgaris |
| Tazarotene Topical GelTazarotene gel 0.1%(finger tip unit of the gel) will be applied once daily for weeks | Drug | group of patients with psoriasis vulgaris |
| Betamethasone Valerate.Betamethasone valerate ointment 0.1% will be applied twice daily for 12 weeks. | Drug | group of patients with psoriasis vulgaris |
Primary outcome
detection of improvement of psoriasis
Time frame: 3 months
detection of improvement of psoriasis in response to excimer laser alone versus its combination with either topical tazarotene gel or betamethasone valerate ointment
1 secondary outcome
dermoscopic role
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
- Results publication: PubMed 29387603Abrouk M, Levin E, Brodsky M, Gandy JR, Nakamura M, Zhu TH, Farahnik B, Koo J, Bhutani T. Excimer laser for the treatment of psoriasis: safety, efficacy, and patient acceptability. Psoriasis (Auckl). 2016 Dec 12;6:165-173. doi: 10.2147/PTT.S105047. eCollection 2016.
- Results publication: PubMed 32508993Ardeleanu V, Sabina Radaschin D, Tatu AL. Excimer laser for psoriasis treatment: A case report and short review. Exp Ther Med. 2020 Jul;20(1):52-55. doi: 10.3892/etm.2020.8529. Epub 2020 Feb 14.
- Results publication: PubMed 33352561He C, Jin H, Liu X, Hu F, Zhang L, Zhang S, He Y, Yang X, Chen H, Wang X, Ji C, Lv C, Miao G, Li X, Diao Q, Li L, Li X, Li Y, Wang R, Zhang L, Zhou X, Xia X, Yan M, Song J, Zhang R, Geng L, Zheng M, Lu Q, Lu T, Shi Y, Jing H, Zhang X, Shi J, Xia J, Gao Y, Wang Y. Tazarotene/Betamethasone Dipropionate Cream in Patients with Plaque Psoriasis: Results of a Prospective, Multicenter, Observational Study. Dermatology. 2021;237(4):603-610. doi: 10.1159/000511891. Epub 2020 Dec 22.
- Results publication: PubMed 32738429Elmets CA, Korman NJ, Prater EF, Wong EB, Rupani RN, Kivelevitch D, Armstrong AW, Connor C, Cordoro KM, Davis DMR, Elewski BE, Gelfand JM, Gordon KB, Gottlieb AB, Kaplan DH, Kavanaugh A, Kiselica M, Kroshinsky D, Lebwohl M, Leonardi CL, Lichten J, Lim HW, Mehta NN, Paller AS, Parra SL, Pathy AL, Siegel M, Stoff B, Strober B, Wu JJ, Hariharan V, Menter A. Joint AAD-NPF Guidelines of care for the management and treatment of psoriasis with topical therapy and alternative medicine modalities for psoriasis severity measures. J Am Acad Dermatol. 2021 Feb;84(2):432-470. doi: 10.1016/j.jaad.2020.07.087. Epub 2020 Jul 30.
- Results publication: PubMed 32129962Nestor MS, Fischer D, Arnold D. Randomized, Investigator-Blinded Study to Compare the Efficacy and Tolerance of a 650-microsecond, 1064-nm YAG Laser to a 308-nm Excimer Laser for the Treatment of Mild to Moderate Psoriasis Vulgaris. J Drugs Dermatol. 2020 Feb 1;19(2):176-183. doi: 10.36849/JDD.2020.4769.
- Results publication: PubMed 15389191Langley 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.
- 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 12810507Taneja A, Trehan M, Taylor CR. 308-nm excimer laser for the treatment of psoriasis: induration-based dosimetry. Arch Dermatol. 2003 Jun;139(6):759-64. doi: 10.1001/archderm.139.6.759.
- Results publication: PubMed 21284407Naldi L, Yawalkar N, Kaszuba A, Ortonne JP, Morelli P, Rovati S, Mautone G. Efficacy and safety of the Betamethasone valerate 0.1% plaster in mild-to-moderate chronic plaque psoriasis: a randomized, parallel-group, active-controlled, phase III study. Am J Clin Dermatol. 2011 Jun 1;12(3):191-201. doi: 10.2165/11539780-000000000-00000.
- Individual participant dataSharing planned: Undecided
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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 308nm Excimer laser, Tazarotene Topical Gel and Betamethasone Valerate in people with Psoriasis, 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 6 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 18 Oct 2022. 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 Doaa S Sayed, professor (01143387171, doaasamir1@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
detection of improvement of psoriasis (time frame: 3 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 NCT05555797, which also lists 9 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 18 Oct 2022.