Topical Calcipotriol /Betamethasone Ointment in the Treatment of Plaque Psoriasis

NCT06011083 | Completed

• 1 other identifier: psoriasis vulgaris
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

comparing the clinical efficacy of topical ointment containing calcipotriol and betamethasone dipropionate used alone with the simultaneous use of fractional carbon dioxide laser and the same topical ointment containing these two ingredients as treatment modalities for plaque psoriasis. Additionally, looking into how both therapy modalities affect individuals with psoriasis in terms of how their quality of life is improved.

Conditions

Psoriasis Vulgaris; Fractional CO2 Laser

Keywords

psoriasis vulgaris; fractional CO2 laser; Calcipotriol /Betamethasone Ointment

Outcome Measures

Primary Outcomes (2)

• Evaluating the reduction in the severity of the treated psoriatic plaques using Psoriasis severity (TES) score before treatment and after the treatment course in both groups.

  Group A included 20 patients who were treated with Topical Ointment containing Calcipotriol 0.05 mg/gm and Betamethasone dipropionate 0.5 mg/gm applied twice daily as a monotherapy for 3 months over a selected psoriatic plaque while Group B included 20 patients who were treated with fractional CO2 laser sessions once per month followed by application of the same topical ointment twice daily for 3 months over a similar psoriatic plaque \[as regard anatomical site, size and TES (thickness, erythema, scales) score\]. We used a physician-based, four-point scoring system in which the thickness, erythema, and scale within each plaque was rated from 0 (none) to 3 (severe) to evaluate the changes in the severity of individual psoriatic plaques before treatment and with each visit till the end of the treatment course. The TES score is the sum of the scores given to each individual parameter (thickness, erythema and scale)

  6 month

• to look into how both therapy modalities affect individuals with psoriasis in terms of how their quality of life is improved.

  Dermatology Life Quality Index (DLQI) is used for quality of life assessment. The DLQI is a validated, 10-question, self-reported questionnaire. It was done to evaluate the patient's perception of the impact of psoriasis on quality of life before and at the end of the treatment course of both groups (14, 15). The DLQI questionnaire was divided into 6 commonly identified categories. The DLQI was rated on a 4-point scale (0 = not at all to 3 = very much). The highest possible total score for the DLQI is 30 and higher scores indicate more severe impact on quality of life (16). According to the score of the DLQI the impact of psoriasis on QOL is then graded into: no effect at all on patient's life (0-1), small effect (2-5), moderate effect (6-10), very large effect (11-20) and extremely large effect on patient's life (21-30).

  6 month

Study Arms (2)

Group A

ACTIVE COMPARATOR

20 patients who were treated with Topical Ointment containing Calcipotriol 0.05 mg/gm and Betamethasone dipropionate 0.5 mg/gm twice daily as a monotherapy for 3 months over a selected psoriatic plaque

Drug: Topical Ointment containing Calcipotriol 0.05 mg/gm and Betamethasone dipropionate 0.5 mg/gm

Group B

ACTIVE COMPARATOR

20 patients who were treated with fractional CO2 laser sessions once per month followed by application of the same Topical Ointment twice daily for 3 months over a similar psoriatic plaque

Drug: Topical Ointment containing Calcipotriol 0.05 mg/gm and Betamethasone dipropionate 0.5 mg/gm; Device: Fractional carbon dioxide (CO2) laser

Interventions

Topical Ointment containing Calcipotriol 0.05 mg/gm and Betamethasone dipropionate 0.5 mg/gm DRUG

using topical ointment containing calcipotriol and betamethasone dipropionate for plaque psoriasis.

Group A; Group B

Fractional carbon dioxide (CO2) laser DEVICE

fractional CO2 laser sessions once per month for 3 months over a similar psoriatic plaque

Group B

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with chronic plaque psoriasis of either sex.
• Aged more than 18 years of age.

You may not qualify if:

• Pregnant and lactating women.
• Patients with severe skin infection.
• Patients who are under systemic ttt or phototherapy in the last 3 months.
• Immunosuppression or being under any kind of treatment causingabsolute or relative immunosuppression
• History of any bleeding, clotting disorder or using anticoagulants.
• Chronic systemic diseases such as chronic renal failure, hepatic insufficiency, and cardiovascular disorders.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, 71511, Egypt

Location

Related Publications (1)

• Griffiths CEM, Armstrong AW, Gudjonsson JE, Barker JNWN. Psoriasis. Lancet. 2021 Apr 3;397(10281):1301-1315. doi: 10.1016/S0140-6736(20)32549-6.

  PMID: 33812489 BACKGROUND

MeSH Terms

Interventions

betamethasone-17,21-dipropionate; Lasers

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: August 25, 2023
• Study Start: August 1, 2022
• Primary Completion: February 28, 2023
• Study Completion: August 1, 2023
• Last Updated: August 25, 2023

Record last verified: 2023-08

Locations

EG (1)