A Novel Combination Oral Agent to Treat Acne Vulgaris

ACNE VULGARIS Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01301586
• Other study ID #: 11022006
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: February 16, 2011
• Last updated: February 18, 2011
• Start date: November 2010
• Est. completion date: September 2011

Study information

• Verified date: February 2011
• Source: Nexgen Dermatologics, Inc.
• Contact: H G Berlin, ESQ
• Phone: 561-739-5252
• Email: garyberlin17[@]hotmail.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 13 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• ACNE VULGARIS

Intervention

Drug:
• Doxycycline and S-equol
Oral doxycycline and s-equol twice a day
• Doxycycline
ORAL DOXYCYCLINE TWICE A DAY

Locations

Country	Name	City	State
United States	Berlin Center	Boynton Beach	Florida
United States	Palos Verdes Dermatology Associates	Rolling Hills Estates	California

Sponsors (1)

Lead Sponsor	Collaborator
Nexgen Dermatologics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The mean number of Inflammatory Lesions on the face at the beginning and end of treatment	The number of inflammatory lesions will be counted by a trained investigator at the beginning and end of treatment.	12 weeks	No
Secondary	The mean number of Comedones will be evaluated at the beginning and end of treatment	A trained investigator will count the number of comedones at the beginning and end of treatment.	12 weeks	No