Clinical trial NCT06011083: 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
Overall status: COMPLETED
Phase: NA
Conditions: Psoriasis Vulgaris
Fractional CO2 Laser
Keywords: psoriasis vulgaris
fractional CO2 laser
Calcipotriol /Betamethasone Ointment
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-08-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: 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.
timeFrame: 6 month
measure: to look into how both therapy modalities affect individuals with psoriasis in terms of how their quality of life is improved.
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
References:
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.