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Topical Calcipotriol /Betamethasone Ointment in the Treatment of Plaque Psoriasis

Primary Purpose

Psoriasis Vulgaris, Fractional CO2 Laser

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Topical Ointment containing Calcipotriol 0.05 mg/gm and Betamethasone dipropionate 0.5 mg/gm
Fractional carbon dioxide (CO2) laser
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis Vulgaris focused on measuring psoriasis vulgaris, fractional CO2 laser, Calcipotriol /Betamethasone Ointment

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with chronic plaque psoriasis of either sex. Aged more than 18 years of age. Exclusion Criteria: 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.

Sites / Locations

  • Assiut University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group A

Group B

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)
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).

Secondary Outcome Measures

Full Information

First Posted
August 21, 2023
Last Updated
August 23, 2023
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT06011083
Brief Title
Topical Calcipotriol /Betamethasone Ointment in the Treatment of Plaque Psoriasis
Official Title
Calcipotriol /Betamethasone Ointment Versus Fractional CO2 Laser Plus Calcipotriol /Betamethasone Ointment in the Treatment of Plaque Psoriasis: Randomized Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
February 28, 2023 (Actual)
Study Completion Date
August 1, 2023 (Actual)

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

5. Study Description

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.
Detailed Description
Psoriasis is a widespread, persistent papulosquamous skin condition that can affect anyone at any age and places a heavy strain on both the individual and society. It is linked to a number of serious medical disorders, such as cardiometabolic syndrome, depression, and psoriatic arthritis (1). Patients with psoriasis indicate that the condition interferes with their ability to sleep and rest, limits their everyday activities, particularly their mobility, and stigmatises them and causes problems in their social lives. Additionally, psoriasis can negatively impact mental health. Many psoriasis sufferers struggle with addiction, anxiety, and depression (2, 3). Topical medicines continue to be the basis of treatment for those with mild psoriasis, and they include topical corticosteroids, vitamin D analogues, calcineurin inhibitors, and keratolytics (4). For the topical management of mild psoriasis, preparations containing calcipotriol in combination with betamethasone (in the form of betamethasone dipropionate) are available (5). In comparison to the effects of these active substances when given separately, pharmacodynamic investigations demonstrated the synergy between the anti-inflammatory and immunoregulatory actions of calcipotriol and betamethasone dipropionate (6). The synergistic activity of the two drugs is what makes calcipotriol/betamethasone dipropionate combinations successful. Betamethasone impacts inflammatory processes and lessens skin irritation and pruritus following calcipotriol administration, while calcipotriol alters keratinocyte differentiation (7). Fractional lasers were used in the treatment of dermatological diseases. They create tiny ablation channels in the skin that act as shunts for topically applied medications, particularly those with high molecular weights (8), by ablation of the skin in the form of fractions and splitting laser beams into microbeams (9).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis Vulgaris, Fractional CO2 Laser
Keywords
psoriasis vulgaris, fractional CO2 laser, Calcipotriol /Betamethasone Ointment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
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
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Topical Ointment containing Calcipotriol 0.05 mg/gm and Betamethasone dipropionate 0.5 mg/gm
Intervention Description
using topical ointment containing calcipotriol and betamethasone dipropionate for plaque psoriasis.
Intervention Type
Device
Intervention Name(s)
Fractional carbon dioxide (CO2) laser
Intervention Description
fractional CO2 laser sessions once per month for 3 months over a similar psoriatic plaque
Primary Outcome Measure Information:
Title
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.
Description
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)
Time Frame
6 month
Title
to look into how both therapy modalities affect individuals with psoriasis in terms of how their quality of life is improved.
Description
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).
Time Frame
6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with chronic plaque psoriasis of either sex. Aged more than 18 years of age. Exclusion Criteria: 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.
Facility Information:
Facility Name
Assiut University
City
Assiut
ZIP/Postal Code
71511
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
33812489
Citation
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.
Results Reference
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Topical Calcipotriol /Betamethasone Ointment in the Treatment of Plaque Psoriasis

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