Excimer Laser With Topical Agents in Psoriasis Vulgaris

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05555797
• Other study ID #: EXCTBVPS
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: October 30, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: October 2022
• Source: Assiut University
• Contact: Doaa S Sayed, professor
• Phone: 01143387171
• Email: doaasamir1[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Age: =18 years.

2. Pattern: Patients with chronic plaque psoriasis not exceeding 10% of the body surface area.

Exclusion Criteria:

1. History of retinoid use either topical or systemic in the previous 16 weeks, phototherapy or topical psoriasis treatment within the last 4 weeks.

2. Allergy to any ingredients of tretinoin or betamethasone drugs.

3. Renal, hepatic disease, cardiovascular , Immunosuppressive therapy, endocrine and blood disease or mental illness.

4. Pregnancy, breast-feeding or women planning to become pregnant within 3 months.

5. Psoriasis exceeding 10% of body surface area or other severe types of psoriasis requiring systemic treatment.

6. Patients with other diseases and requiring treatment that would affect the study

Related Conditions & MeSH terms

• Psoriasis

Intervention

Device:
• 308nm Excimer laser
Excimer laser will be (1-2 sessions/ week for 12 sessions according to induration protocol)

Drug:
• Tazarotene Topical Gel
Tazarotene gel 0.1%(finger tip unit of the gel) will be applied once daily for weeks
• Betamethasone Valerate
.Betamethasone valerate ointment 0.1% will be applied twice daily for 12 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (9)

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. eColle — View 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. — View 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, — View 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, — View 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. — View 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 — View 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 — View 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):996-100 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 months
Secondary	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.	3 months