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

NCT06015152 | Completed

• 1 other identifier: NO.F.2-81/2022-GENL/251/JPMC
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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. .

Conditions

Scalp Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

GROUP A Tazarotene 0.045%

EXPERIMENTAL

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]

GROUP B Halobetasol Propionate 0.01%

EXPERIMENTAL

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]

Interventions

Tazarotene 0.045% Topical Application Lotion [ARAZLO] DRUG

\[ARAZLO\]

GROUP A Tazarotene 0.045%; GROUP B Halobetasol Propionate 0.01%

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jinnah Postgraduate Medical Centre: lead

Study Sites (1)

JPMC

Karachi, Sindh, Pakistan

Location

MeSH Terms

Interventions

tazarotene

Study Officials

• PARISA SANAWAR, FCPS

  JPMC

  PRINCIPAL INVESTIGATOR

• KHADIJA ASADULLAH, FCPS

  JPMC

  PRINCIPAL INVESTIGATOR

• FAIZA INAM, FCPS

  JPMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 25, 2023
• First Posted: August 29, 2023
• Study Start: August 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: February 1, 2023
• Last Updated: August 29, 2023

Record last verified: 2023-08

Locations

PA (1)