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

Comparison Of The Efficacy Of Tazarotene 0.045% Versus Halobetasol Propionate 0.01% Lotion For the Treatment of Scalp Psoriasis

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. .

Study Overview

• Status: Completed
• Conditions: Scalp Psoriasis
• Intervention / Treatment: Drug: Tazarotene 0.045% Topical Application Lotion [ARAZLO]

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan
      • JPMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GROUP A Tazarotene 0.045%; 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.	Drug: Tazarotene 0.045% Topical Application Lotion [ARAZLO]; [ARAZLO]
Experimental: GROUP B Halobetasol Propionate 0.01%; 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. .	Drug: Tazarotene 0.045% Topical Application Lotion [ARAZLO]; [ARAZLO]

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The efficacy of Tazarotene 0.045% in Scalp Psoriasis	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	Efficacy will be assessed after 02 weeks

Collaborators and Investigators

• Sponsor: Jinnah Postgraduate Medical Centre
• Investigators: Principal Investigator: KHADIJA ASADULLAH, FCPS, JPMC; Principal Investigator: FAIZA INAM, FCPS, JPMC; Principal Investigator: PARISA SANAWAR, FCPS, JPMC

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: March 25, 2023
• First Submitted That Met QC Criteria: August 28, 2023
• First Posted (Actual): August 29, 2023

Study Record Updates

• Last Update Posted (Actual): August 29, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Dermatologic Agents; Keratolytic Agents; Tazarotene
• Other Study ID Numbers: NO.F.2-81/2022-GENL/251/JPMC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No