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

Sponsor
Jinnah Postgraduate Medical Centre (Other)
Overall Status
Completed
CT.gov ID
NCT06015152
Collaborator
(none)
90
1
2
6
14.9

Study Details

Study Description

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. .

Condition or Disease Intervention/Treatment Phase
  • Drug: Tazarotene 0.045% Topical Application Lotion [ARAZLO]
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparison Of The Efficacy Of Tazarotene 0.045% Versus Halobetasol Propionate 0.01% Lotion For the Treatment of Scalp Psoriasis
Actual Study Start Date :
Aug 1, 2022
Actual Primary Completion Date :
Dec 1, 2022
Actual Study Completion Date :
Feb 1, 2023

Arms and Interventions

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]

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 JPMC Karachi Sindh Pakistan

Sponsors and Collaborators

  • Jinnah Postgraduate Medical Centre

Investigators

  • Principal Investigator: PARISA SANAWAR, FCPS, JPMC
  • Principal Investigator: KHADIJA ASADULLAH, FCPS, JPMC
  • Principal Investigator: FAIZA INAM, FCPS, JPMC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nazia Jabeen, Principal Investigator, Jinnah Postgraduate Medical Centre
ClinicalTrials.gov Identifier:
NCT06015152
Other Study ID Numbers:
  • NO.F.2-81/2022-GENL/251/JPMC
First Posted:
Aug 29, 2023
Last Update Posted:
Aug 29, 2023
Last Verified:
Aug 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 29, 2023