A Novel Combination Oral Agent to Treat Acne Vulgaris

Phase 1

• Conditions: ACNE VULGARIS
• Interventions: Drug: Doxycycline and S-equol; Drug: Doxycycline

• Registration Number: NCT01301586
• Lead Sponsor: Nexgen Dermatologics, Inc.

Brief Summary

The purpose of this study is to evaluate a novel, combination product for the treatment of acne vulgaris in females

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Status Verified: 2011-02
• Study First Submitted: 2011-02-16
• Study First Submitted QC: 2011-02-18
• Last Update Submitted: 2011-02-18
• Study First Posted: 2011-02-23
• Last Update Posted: 2011-02-23
• Primary Completion: 2011-09
• Study Completion: 2011-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Healthy females 13 years of age or older
• Non-pregnant, non-lactating females
• Signed written informed consent form
• Must be able to understand and be willing to follow all study instructions
• Have a clinical diagnosis of acne vulgaris

Exclusion Criteria

• Female subjects who are pregnant or nursing
• Any concomitant dermatologic condition that may affect outcome measures
• Concurrent use of any other medication to treat acne vulgaris
• Have a history or clinical evidence of any other active acute or chronic medical disease or condition considered by the principal investigator as unsuitable for the study
• Are currently using any other investigational agent or device
• Have participated in any other clinical study within 90 days prior to enrollment
• Employees or family members of sponsor or research site

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral antibiotic plus soy extract	Doxycycline and S-equol	-
Oral antibiotic	Doxycycline	-

Primary Outcome Measures

Name	Time	Method
The mean number of Inflammatory Lesions on the face at the beginning and end of treatment	12 weeks	The number of inflammatory lesions will be counted by a trained investigator at the beginning and end of treatment.

Secondary Outcome Measures

Name	Time	Method
The mean number of Comedones will be evaluated at the beginning and end of treatment	12 weeks	A trained investigator will count the number of comedones at the beginning and end of treatment.

Trial Locations

Locations (2)

Berlin Center; 🇺🇸 Boynton Beach, Florida, United States

Palos Verdes Dermatology Associates; 🇺🇸 Rolling Hills Estates, California, United States