A Novel Combination Oral Agent to Treat Acne Vulgaris

• Sponsor: Nexgen Dermatologics, Inc. (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT01301586
• Collaborator: (none)
• Enrollment: 60
• Locations: 2
• Arms: 2
• Duration (Months): 10
• Patients Per Site: 30
• Patients Per Site Per Month: 3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
ACNE VULGARIS	Drug: Doxycycline and S-equol; Drug: Doxycycline	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE SAFETY AND EFFICACY OF A NOVEL ORAL ACNE TREATMENT FOR THE TREATMENT OF ACNE VULGARIS
• Study Start Date: Nov 1, 2010
• Anticipated Primary Completion Date: Sep 1, 2011
• Anticipated Study Completion Date: Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Oral antibiotic plus soy extract	Drug: Doxycycline and S-equol; Oral doxycycline and s-equol twice a day
Active Comparator: Oral antibiotic	Drug: Doxycycline; ORAL DOXYCYCLINE TWICE A DAY

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 13 Years to 60 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Palos Verdes Dermatology Associates	Rolling Hills Estates	California	United States	90274
2	Berlin Center	Boynton Beach	Florida	United States	33437

Sponsors and Collaborators

• Nexgen Dermatologics, Inc.

Investigators

• Principal Investigator: Joshua M Berlin, MD, Study Protocol, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01301586
• Other Study ID Numbers: 11022006
• First Posted: Feb 23, 2011
• Last Update Posted: Feb 23, 2011
• Last Verified: Feb 1, 2011

• Additional relevant MeSH terms: Acne Vulgaris; Doxycycline

Study Results

No Results Posted as of Feb 23, 2011