Evaluation of Adrenal Suppression Potential and Pharmacokinetics of Halobetasol Lotion 0.05%

NCT03212963 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 177-0551-201
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 3

Brief Summary

The objective of this open-label multicentric study is to determine the adrenal suppression potential and the pharmacokinetic (PK) properties of halobetasol lotion (HBP) applied twice daily for up to two weeks in subjects aged 12 to 16 years 11 months with stable plaque psoriasis. Subject enrollment will continue until at least 20 subjects with both screening and end of study (EOS) serum cortisol data (pre- and pos-tcosyntropin stimulation) have completed the study without any significant protocol violations (evaluable subjects). This may require the enrollment of approximately 25 subjects.

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (4)

• Investigator's Global Assessment

  The IGA score (5-point scale of 0 to 4: 0\[clear\]; 1\[almost clear\]; 2\[mild\]; 3\[moderate\]; 4\[severe\]) is an evaluation of the overall severity of a subject's psoriasis in the Treatment Area and takes into consideration the 3 individual characteristics of psoriasis (scaling, erythema, and plaque elevation).

  Day 15

• Percent BSA Affected With Disease

  The Percent Body Surface Area (BSA) Affected with Disease was defined as the BSA which was affected with psoriasis within the Treatment Area.

  Day 15

• Percent Body Surface Area Treated With Test Article

  The Percent Body Surface Area Treated with Test Article was defined as the BSA which was affected with psoriasis within the Treatment Area that was treated.

  Day 8

• Number of Subjects With Abnormal Hypothalamus-Pituitary-Adrenal Axis Response

  An abnormal Hypothalamus-Pituitary-Adrenal (HPA) axis was response was defined as a 30-minute post-stimulation serum cortisol level of ≤18 μg/dL at end of study (EOS)

  Day 15

Study Arms (1)

Halobetasol lotion treatment arm

EXPERIMENTAL

All subjects will receive Halobetasol Topical Lotion, 0.05%.

Drug: Halobetasol Topical Lotion

Interventions

Halobetasol Topical Lotion DRUG

Halobetasol Lotion 0.05%, applied twice daily in subjects aged 12 to 16 years 11 months with stable plaque psoriasis.

Also known as: Halobetasol topical lotion 0.05%

Halobetasol lotion treatment arm

Eligibility Criteria

• Age: 12 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Subject is male or non-pregnant female and is 12 to 16 years 11 months of age.
• Subject has provided written informed assent and was accompanied by the parent or legal guardian at the time of assent/consent signing. The parent or legal guardian has provided informed consent for the subject. 3. Subject has a clinical diagnosis of stable plaque psoriasis involving a minimum of 10% body surface area (BSA) within the Treatment Area. The "Treatment Area" is defined as the entire body exclusive of the face, scalp, groin, axillae, and other intertriginous areas.
• \. Subject has an Investigator's Global Assessment (IGA) score of at least three (3 = moderate) at the Baseline Visit.
• \. Subject is willing and able to apply the test article as directed, comply with study instructions and commit to all follow-up visits for the duration of the study.
• \. Females must have a negative urine pregnancy test (UPT) at the Screening and Baseline Visits and agree to use an effective form of birth control for the duration of the study.

You may not qualify if:

• Subject has spontaneously improving or rapidly deteriorating plaque psoriasis.
• Subject has guttate, pustular, erythrodermic or other non-plaque forms of psoriasis.
• Subject has a physical condition which, in the investigator's opinion, might impair evaluation of plaque psoriasis, adrenal axis function (e.g., Addison's Disease, Cushing's Syndrome) or which exposes the subject to an unacceptable risk by study participation.
• Subject has used any phototherapy (including laser), photochemotherapy or systemic psoriasis therapy including methotrexate, retinoids, cyclosporine or biologics within 30 days prior to the initiation of treatment with the test article.
• Subject has used systemic corticosteroids (including oral or intramuscular) or topical, inhaled or intranasal corticosteroids within 30 or 14 days, respectively, prior to Part B of the Screening Visit and/or the subject has used systemic or topical corticosteroids between Part B of the Screening Visit and the initiation of treatment.
• Subject has had prolonged exposure to natural or artificial sources of ultraviolet radiation within 30 days prior to the initiation of treatment or is intending to have such exposure during the study that is thought by the investigator to likely modify the subject's disease.
• Subject has used topical psoriatic therapy including tar, anthralin, retinoids, vitamin D analogs (e.g., Dovonex®) within 14 days prior to the initiation of treatment with the test article.
• Subject has used emollients/moisturizers on areas to be treated within one day prior to the initiation of treatment with the test article.
• Subject is currently using lithium or Plaquenil (hydroxychloroquine).
• Subject is currently using a beta-blocking medication (e.g., propranolol) or angiotensin converting enzyme (ACE) inhibitors (e.g., lisinopril) at a dose that has not been stabilized, in the opinion of the investigator.
• Subject has a history of sensitivity to any of the ingredients in the test article.
• Subject is pregnant, lactating, or is planning to become pregnant during the study.
• Subject is currently enrolled in an investigational drug or device study.
• Subject has used an investigational drug or investigational device treatment within 30 days prior to Visit 1 (Screening).
• Subject has been previously enrolled in this study and treated with the test article.

Sponsors & Collaborators

• Sun Pharmaceutical Industries Limited: lead

Study Sites (3)

First OC Dermatology

Fountain Valley, California, 92708, United States

Location

Power MD Clinical Research Institute

Hialeah, Florida, 33012, United States

Location

MediSearch Clinical Trials

Saint Joseph, Missouri, 64506, United States

Location

Results Point of Contact

• Title: Head, Clinical Development
• Organization: Sun Pharma Advanced Research Company Ltd.

clinical.trials@sparcmail.com

912266455645

Study Officials

• Stephanie Magajna, MS

  Therapeutics, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label study to evaluate adrenal suppression potential and pharmacokinetics of halobetasol lotion 0.05%

Study Record Dates

• First Submitted: April 18, 2017
• First Posted: July 11, 2017
• Study Start: March 21, 2017
• Primary Completion: August 12, 2019
• Study Completion: August 12, 2019
• Last Updated: December 7, 2021
• Results First Posted: December 7, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)