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

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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04624867

Enrollment

240

Registered

2020-11-12

Start date

2020-11-03

Completion date

2022-01-31

Last updated

2021-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cumulative Irritation and Sensitization

Brief 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.

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.

Interventions

DRUGHP-1050 Patch

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 35 Years

Healthy volunteers

Yes

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;

Design outcomes

Primary

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

Countries

United States

Contacts

Primary ContactStudy Director

ClinicalTrials@noven.com305 253 5099

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026