Comparison Of Efficacy Of Tazarotene 0.045% Vs Halobetasol Propionate 0.01% Lotion For Treatment of Scalp Psoriasis

Not Applicable

Completed

• Conditions: Scalp Psoriasis
• Interventions: Drug: Tazarotene 0.045% Topical Application Lotion [ARAZLO]

• Registration Number: NCT06015152
• Lead Sponsor: Jinnah Postgraduate Medical Centre

Brief Summary

Psoriasis is a serious, immune-driven illness that affects around 2% of the population and has a wide range of clinical manifestations 1-3 . Many patients have localized illness, and topical therapy can be an important part of treatment.

tazarotene is the first receptor-selective retinoid for the topical treatment of plaque psoriasis. On application, tazarotene is rapidly hydrolyzed to its main metabolite, tazarotenic acid, which binds to retinoic acid receptors (RARs) in the nucleus. Tazarotenic acid selectively binds to RARs b and g . The predominant type of RAR expressed in the human epidermis is RAR, indicating that it may be an important mediator of retinoid action in skin. .

Detailed Description

Topical Corticosteroids is commonly used in situations of mild to moderate disease severity. However, long-term safety is still an issue, especially when utilizing stronger formulations,which come with a higher risk of local cutaneous adverse events (AEs). Telangiectasia, suppression of the hypothalamic-pituitary-adrenal (HPA) axis, and skin shrinkage are some of these negative consequences. By regulating gene transcription, tazarotene normalizes abnormal keratinocyte differentiation, reduces epidermal hyperproliferation, and decreases inflammation, the three pathogenic factors in psoriasis, thereby producing a more normal expression of skin differentiation in psoriatic lesions

Study Timeline

• Study Start: 2022-08-01
• Primary Completion: 2022-12-01
• Study Completion: 2023-02-01
• Study First Submitted: 2023-03-25
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-28
• Last Update Submitted: 2023-08-28
• Study First Posted: 2023-08-29
• Last Update Posted: 2023-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Patients between 30-50 years of age, either gender presenting with scalp psoriasis as per operational definition will be included in the study.

Exclusion Criteria

• pustular psoriasis or had used phototherapy, photochemotherapy, or systemic psoriasis therapy within the last four weeks (or biologics within the last three months).
• Used topical treatment within 14 days prior to the baseline visit or who were diagnosed with skin conditions that would interfere with the interpretation of results were also excluded.

pregnant women, women attempting to become pregnant, lactation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GROUP A Tazarotene 0.045%	Tazarotene 0.045% Topical Application Lotion [ARAZLO]	Topical tazarotene 0.045% and halobetasol Propionate 0.01% . TAZ is the first receptor-selective retinoid used externally to treat plaque psoriasis . The major metabolite of tazarotene, tazarotenic acid, is quickly formed after application and binds to retinoic acid receptors (RARs) in the nucleus. Tazarotenic acid has a weak affinity for retinoid X receptors and prefers to bind to RARs b and g. Halobetasol propionate is a medication used to treat scalp psoriasis. It is a form of topical corticosteroid, which means it works by suppressing the immune system and reducing inflammation.
GROUP B Halobetasol Propionate 0.01%	Tazarotene 0.045% Topical Application Lotion [ARAZLO]	Topical tazarotene 0.045% and halobetasol Propionate 0.01% . TAZ is the first receptor-selective retinoid used externally to treat plaque psoriasis . The major metabolite of tazarotene, tazarotenic acid, is quickly formed after application and binds to retinoic acid receptors (RARs) in the nucleus. Tazarotenic acid has a weak affinity for retinoid X receptors and prefers to bind to RARs b and g. Halobetasol propionate is a medication used to treat scalp psoriasis. It is a form of topical corticosteroid, which means it works by suppressing the immune system and reducing inflammation. .

Primary Outcome Measures

Name	Time	Method
The efficacy of Tazarotene 0.045% in Scalp Psoriasis	Efficacy will be assessed after 02 weeks	Efficacy will be assessed by using Investigator's Global Assessment score for scalp psoriasis which is typically a 5-point scale from 0 to 4, with 0 = Clear/No Disease, 1 = Almost Clear, 2 = Mild, 3 = Moderate and 4 = Severe.; Mean diference of IGA score before and after treatment will be calculated

Trial Locations

Locations (1)

JPMC; 🇵🇰 Karachi, Sindh, Pakistan