Topical Calcipotriol /Betamethasone Ointment in the Treatment of Plaque Psoriasis

• ClinicalTrials.gov Identifier: NCT06011083
• Recruitment Status: Completed
• First Posted: August 25, 2023
• Last Update Posted: August 25, 2023
• Sponsor: Assiut University
• Information provided by (Responsible Party): Heba Hasan Sayed, Assiut University

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.

Condition or disease	Intervention/treatment	Phase
Psoriasis Vulgaris; Fractional CO2 Laser	Drug: Topical Ointment containing Calcipotriol 0.05 mg/gm and Betamethasone dipropionate 0.5 mg/gm; Device: Fractional carbon dioxide (CO2) laser	Not Applicable

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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Calcipotriol /Betamethasone Ointment Versus Fractional CO2 Laser Plus Calcipotriol /Betamethasone Ointment in the Treatment of Plaque Psoriasis: Randomized Comparative Study
• Actual Study Start Date: August 1, 2022
• Actual Primary Completion Date: February 28, 2023
• Actual Study Completion Date: August 1, 2023

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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	Drug: 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.
Active Comparator: 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	Drug: 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.; Device: Fractional carbon dioxide (CO2) laser; fractional CO2 laser sessions once per month for 3 months over a similar psoriatic plaque

Outcome Measures

Primary Outcome Measures :

1. 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. [ Time Frame: 6 month ]

   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)

2. to look into how both therapy modalities affect individuals with psoriasis in terms of how their quality of life is improved. [ Time Frame: 6 month ]
   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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Egypt

Assiut University

Assiut, Egypt, 71511

Sponsors and Collaborators

Assiut University

More Information

Publications:

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.

• Responsible Party: Heba Hasan Sayed, Doctor, Assiut University
• ClinicalTrials.gov Identifier: NCT06011083
• Other Study ID Numbers: psoriasis vulgaris
• First Posted: August 25, 2023
• Last Update Posted: August 25, 2023
• Last Verified: August 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Heba Hasan Sayed, Assiut University:

psoriasis vulgaris; fractional CO2 laser; Calcipotriol /Betamethasone Ointment

Additional relevant MeSH terms:

Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Calcipotriene; Betamethasone sodium phosphate; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Anti-Asthmatic Agents; Respiratory System Agents; Dermatologic Agents