Topical Calcipotriol /Betamethasone Ointment in the Treatment of Plaque Psoriasis

NCT ID: NCT06011083

Last Updated: 2023-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2023-08-01

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).

Conditions

Psoriasis Vulgaris; Fractional CO2 Laser

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

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

Group B

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

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

Fractional carbon dioxide (CO2) laser

Intervention Type: DEVICE

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

Interventions

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

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

Intervention Type: DRUG

Fractional carbon dioxide (CO2) laser

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Heba Hasan Sayed

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Assiut University

Asyut, , Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 33812489 (View on PubMed)

Other Identifiers

psoriasis vulgaris

Identifier Type: -

Identifier Source: org_study_id