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

Cumulative Irritation and Sensitization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04624867
• Other study ID #: HP-1050-US-02
• Status: Recruiting
• Phase: Phase 1
• Start date: November 3, 2020
• Est. completion date: January 31, 2022

Study information

• Verified date: August 2021
• Source: Noven Therapeutics
• Contact: Study Director
• Phone: 305 253 5099
• Email: ClinicalTrials[@]noven.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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;

Related Conditions & MeSH terms

• Cumulative Irritation and Sensitization

Intervention

Drug:
• HP-1050 Patch
Both articles, HP-1050 and XULANE patch, will be applied simultaneously on the back of each subject.

Locations

Country	Name	City	State
United States	QPS Missouri	Springfield	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Noven Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin Irritation Evaluation	To evaluate skin irritation after exposure to HP-1050 compared to XULANE®	21 days
Primary	Sensitization Evaluation	To evaluate skin sensitization after exposure to HP-1050 compared to XULANE®	48 hours