Study Will Assess Skin Irritation and Sensitization for HP-1050 Patch

August 31, 2021 updated by: Noven Pharmaceuticals, Inc.

A Phase I Study to Assess Skin Irritation and Sensitization of HP-1050 Transdermal System Compared to XULANE in Healthy Adult Females

A randomized, evaluator-blinded study to assess skin irritation and skin sensitization of HP-1050 transdermal system (HP-1050) in comparison to XULANE patch in healthy female volunteers.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a dual-center, evaluator-blinded, randomized phase 1 study evaluating skin irritation and skin sensitization of HP-1050 transdermal system in comparison to XULANE patch in healthy female volunteers. The study will consist of a 4-week Screening Phase and a Treatment Phase. The Treatment Phase will consist of the following periods: an Induction Period, a Rest Period followed by a Challenge Period and if needed, a Re-Challenge Period.

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Missouri
      • Springfield, Missouri, United States, 65802
        • Recruiting
        • QPS Missouri
        • Contact:
          • Study Director

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Healthy non-pregnant, non-lactating females 18-35 years of age (inclusive0 and who are candidates for hormonal contraception;
  • Subjects who have previously used hormonal contraceptives without complications or naïve subjects for whom hormonal contraceptives are not contraindicated in the opinion of the Principal Investigator;
  • Subjects who are willing to stop using any current contraceptives for the duration of the study;

Exclusion Criteria:

  • Subjects who are currently taking or have taken oral hormonal contraceptives within 30 days prior to the first patch application;
  • Subjects who are currently using any long-acting hormonal method of contraception or has used them within the past 3 months;
  • Subjects who have a contraindication for estrogen or norelgestromin, or subjects who have a history of sensitivity to estrogen or norelgestromin or any related derivatives;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HP-1050 patch
HP-1050 and Xulane will be administered simultaneously.
Drug: HP-1050 Patch
Both articles, HP-1050 and XULANE patch, will be applied simultaneously on the back of each subject.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin Irritation Evaluation
Time Frame: 21 days
To evaluate skin irritation after exposure to HP-1050 compared to XULANE®
21 days
Sensitization Evaluation
Time Frame: 48 hours
To evaluate skin sensitization after exposure to HP-1050 compared to XULANE®
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Noven Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 3, 2020

Primary Completion (Anticipated)

January 31, 2022

Study Completion (Anticipated)

January 31, 2022

Study Registration Dates

First Submitted

October 22, 2020

First Submitted That Met QC Criteria

November 5, 2020

First Posted (Actual)

November 12, 2020

Study Record Updates

Last Update Posted (Actual)

September 1, 2021

Last Update Submitted That Met QC Criteria

August 31, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • HP-1050-US-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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