Excimer Laser With Topical Agents in Psoriasis Vulgaris
Primary Purpose
Psoriasis
Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
308nm Excimer laser
Tazarotene Topical Gel
Betamethasone Valerate
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis
Eligibility Criteria
Inclusion Criteria:
- Age: ≥18 years.
- Pattern: Patients with chronic plaque psoriasis not exceeding 10% of the body surface area.
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
group of patients with psoriasis vulgaris
Arm Description
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%
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05555797
Brief Title
Excimer Laser With Topical Agents in Psoriasis Vulgaris
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 30, 2022 (Anticipated)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group of patients with psoriasis vulgaris
Arm Type
Experimental
Arm Description
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%
Intervention Type
Device
Intervention Name(s)
308nm Excimer laser
Intervention Description
Excimer laser will be (1-2 sessions/ week for 12 sessions according to induration protocol)
Intervention Type
Drug
Intervention Name(s)
Tazarotene Topical Gel
Intervention Description
Tazarotene gel 0.1%(finger tip unit of the gel) will be applied once daily for weeks
Intervention Type
Drug
Intervention Name(s)
Betamethasone Valerate
Intervention Description
.Betamethasone valerate ointment 0.1% will be applied twice daily for 12 weeks.
Primary Outcome Measure Information:
Title
detection of improvement of psoriasis
Description
detection of improvement of psoriasis in response to excimer laser alone versus its combination with either topical tazarotene gel or betamethasone valerate ointment
Time Frame
3 months
Secondary Outcome Measure Information:
Title
dermoscopic role
Description
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.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age: ≥18 years.
Pattern: Patients with chronic plaque psoriasis not exceeding 10% of the body surface area.
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Doaa S Sayed, professor
Phone
01143387171
Email
doaasamir1@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Eman F Ahmed, Doctor
Phone
01002258614
Email
emanfathey639@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29387603
Citation
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.
Results Reference
result
PubMed Identifier
32508993
Citation
Ardeleanu 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 Reference
result
PubMed Identifier
33352561
Citation
He 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 Reference
result
PubMed Identifier
32738429
Citation
Elmets 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 Reference
result
PubMed Identifier
32129962
Citation
Nestor 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 Reference
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PubMed Identifier
15389191
Citation
Langley 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.
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Citation
Ramez 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 Reference
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PubMed Identifier
12810507
Citation
Taneja 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.
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Citation
Naldi 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.
Results Reference
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Excimer Laser With Topical Agents in Psoriasis Vulgaris
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