NCT05555797

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2022

Shorter than P25 for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 27, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

October 30, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

October 18, 2022

Status Verified

October 1, 2022

Enrollment Period

11 months

First QC Date

September 17, 2022

Last Update Submit

October 15, 2022

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • dermoscopic role

    3 months

Study Arms (1)

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%

Device: 308nm Excimer laserDrug: Tazarotene Topical GelDrug: Betamethasone Valerate

Interventions

308nm Excimer laserDEVICE

Excimer laser will be (1-2 sessions/ week for 12 sessions according to induration protocol)

group of patients with psoriasis vulgaris
Tazarotene Topical GelDRUG

Tazarotene gel 0.1%(finger tip unit of the gel) will be applied once daily for weeks

group of patients with psoriasis vulgaris
Betamethasone ValerateDRUG

.Betamethasone valerate ointment 0.1% will be applied twice daily for 12 weeks.

group of patients with psoriasis vulgaris

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: ≥18 years.
  • Pattern: Patients with chronic plaque psoriasis not exceeding 10% of the body surface area.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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. eCollection 2016.

    PMID: 29387603RESULT

  • 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.

    PMID: 32508993RESULT

  • 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.

    PMID: 33352561RESULT

  • 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.

    PMID: 32738429RESULT

  • 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.

    PMID: 32129962RESULT

  • 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.

    PMID: 15389191RESULT

  • 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.

    PMID: 29448838RESULT

  • 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.

    PMID: 12810507RESULT

  • 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.

    PMID: 21284407RESULT

MeSH Terms

Conditions

Psoriasis

Interventions

Lasers, ExcimerBetamethasone Valerate

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and SuppliesBetamethasonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Central Study Contacts

Doaa S Sayed, professor

CONTACT

01143387171doaasamir1@yahoo.com

Eman F Ahmed, Doctor

CONTACT

01002258614emanfathey639@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 17, 2022

First Posted

September 27, 2022

Study Start

October 30, 2022

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

October 18, 2022

Record last verified: 2022-10