Clobetasol Topical Oil for Children With Moderate to Severe Atopic Dermatitis

NCT03847389 | Terminated Phase 1 Results DMC FDA Drug

• 1 other identifier: CP0418 SS-P2 051
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 6

Brief Summary

Open-Label Study designed to evaluate the HPA axis suppression potential of Clobetasol Topical Oil and pharmacokinetic safety / systemic exposure to clobetasol when Clobetasol Topical Oil is applied to pediatric subjects with moderate to severe atopic dermatitis (AD) under maximal use conditions. The study duration for each subject will be up to 54 days (up to 38 days for Screening assessments, followed by up to 16 days of treatment and follow-up). Additional time will be required for subjects requiring additional hypothalamic-pituitary-adrenal \[HPA\] axis function testing due to an abnormal result at End of Treatment.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (2)

• Number of Participants With HPA Axis Suppression - Serum Cortisol Concentration (Cortrosyn Stimulation Test)

  30-minute Post-stimulation cortisol level ≤18 µg/100 mL at Day 0 means subject is not enrolled; 30-minute Post-stimulation cortisol level ≤18 µg/100 mL at end of treatment (Day 15) means subject had suppression.

  day 0 and day 15.

• Adverse Events, Including Treatment Emergent Adverse Events (TEAEs)

  number of events and percentage of subjects with AEs including TEAEs

  Days 0, 1, 8 and 15

Other Outcomes (2)

• ISGA Category

  Days 0, 1, 8 and 15 Efficacy assessment, including ISGA, was not performed due to premature termination of the study.

• Assessment of Burning/Stinging, Skin Atrophy, Striae, Folliculitis, and Telangiectasias (Tolerability Parameters).

  Days 1, 8 and 15

Study Arms (1)

clobetasol propionate topical oil

OTHER

clobetasol propionate 0.05% topical oil applied as thin film twice daily for 2 weeks

Drug: Clobetasol propionate 0.05% Topical Oil

Interventions

Clobetasol propionate 0.05% Topical Oil DRUG

thin film application of the oil twice daily

Also known as: clobetasol propionate topical solution

clobetasol propionate topical oil

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male or female subjects in good general health confirmed by medical history.
• Subjects with a clinical diagnosis of AD (according to the criteria of Hanifin and Rajka) of moderate to severe intensity (ISGA score of 3 or 4) involving ≥25% to ≤50% of total BSA located within treatable areas (Cohort 1), or ≥35% to ≤50% of total BSA located within treatable areas (Cohorts 2 and 3), with treatable areas including all but the face, axillae, groin, and scalp.
• Subjects with a normally functioning HPA axis, defined as a prestimulation serum cortisol level \>5 µg/100 mL, and a response to cosyntropin stimulation to \>18 µg/100 mL (after approximately 30 minutes); both blood draws for this test should be performed in the morning, if possible
• Female subjects of childbearing potential must have a negative urine pregnancy test, must not be breastfeeding, and must agree to use an acceptable form of birth control for the duration of the study. Female subjects of childbearing potential are defined as all female subjects who have reached menarche and are not two years postmenopausal or who have reached menarche and have not had a hysterectomy, bilateral tubal ligation, and/or complete bilateral oophorectomy

You may not qualify if:

• Subjects with an abnormal sleep schedule or who work at night.
• Subjects who have used topical dermal corticosteroids or topical immunomodulators (e.g., tacrolimus or pimecrolimus) within 3 weeks before Day 1, and subjects who are using any systemic medication known to affect cortisol levels or HPA axis integrity, systemic corticosteroids, an acute systemic course of corticosteroids, and/or any biological medication within 30 days before Day 1.
• Subjects with concomitant medical or dermatologic disorders (neurodermatitis, skin atrophy, striae, telangiectasia, etc.) that may interfere with study objectives and/or evaluations.
• Subjects with active skin infection.
• Subjects with any known significant endocrinological disorder that may require prohibited treatment, any known underlying disease that the investigator deems uncontrolled and poses a safety risk for the subject while participating in the study, known sensitivity to any ingredient of the study preparation, or a history of adverse responses to topical or systemic steroid therapy.
• Subjects who are pregnant or nursing.
• Subjects who have used bleach baths, phototherapy, and/or tanning beds, and/or who have had excessive sun exposure within 1 week before Day 1 and/or are planning to use any of these during the study.
• Subjects who have participated in a clinical drug or device research study and/or used any investigational treatment within the last 30 days before Day

Sponsors & Collaborators

• Hill Dermaceuticals, Inc.: lead
• Synteract, Inc.: collaborator
• Covance: collaborator

Study Sites (6)

International Clinical Research - US, LLC

Sanford, Florida, 32771, United States

Location

AeroAllergy Research Laboratories of Savannah, Inc

Savannah, Georgia, 31406, United States

Location

Paddington Testing Co., Inc.

Philadelphia, Pennsylvania, 19103, United States

Location

Spartanburg Medical Research

Spartanburg, South Carolina, 29303, United States

Location

Progressive Clinical Research

San Antonio, Texas, 78213, United States

Location

Clinical Research Partners, LLC

Richmond, Virginia, 23220, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Clobetasol; Oils

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Betamethasone; Steroids, Fluorinated; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Lipids

Limitations and Caveats

The study was terminated early due to the COVID pandemic with very low subject enrollment. Due to the small number of subjects that completed when the study was prematurely terminated, pharmacokinetic, exploratory, sensitivity, as well as some safety analyses was not completed under the SAP.

Results Point of Contact

• Title: Rosario G Ramirez, MD
• Organization: Hill Dermaceuticals, Inc.

nini.ramirez@hillderm.com

4073231887

Study Officials

• Rosario G Ramirez, MD

  Hill Dermaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: open-label, maximal use, in 3 successive age cohorts

Study Record Dates

• First Submitted: January 23, 2019
• First Posted: February 20, 2019
• Study Start: September 9, 2019
• Primary Completion: May 2, 2020
• Study Completion: July 28, 2020
• Last Updated: June 23, 2021
• Results First Posted: June 23, 2021

Record last verified: 2021-01

Locations

US (6)