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

Scalp Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06015152
• Other study ID #: NO.F.2-81/2022-GENL/251/JPMC
• Status: Completed
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: February 1, 2023

Study information

• Verified date: August 2023
• Source: Jinnah Postgraduate Medical Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. .

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis
• Scalp Psoriasis

Intervention

Drug:
• Tazarotene 0.045% Topical Application Lotion [ARAZLO]
[ARAZLO]

Locations

Country	Name	City	State
Pakistan	JPMC	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Jinnah Postgraduate Medical Centre

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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