Recruiting
Phase 1
Phase 2

Oral Agent

Sponsor:

Nexgen Dermatologics, Inc.

Code:

NCT01301586

Conditions

ACNE VULGARIS

Eligibility Criteria

Sex: Female

Age: 13 - 60

Healthy Volunteers: Accepted

Interventions

Doxycycline and S-equol

Doxycycline

Study Details

Brief summary:

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

Conditions

ACNE VULGARIS

Study ID

NCT01301586

Start date

Nov, 2010

Status verified date

Feb, 2011

Completion date

Sep, 2011

Anticipated

Primary completion date

Sep, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 13 - 60

Healthy Volunteers: Accepted

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

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Oral antibiotic plus soy extract

active comparator: Oral antibiotic

Interventions

Doxycycline and S-equol

Oral doxycycline and s-equol twice a day

Doxycycline

ORAL DOXYCYCLINE TWICE A DAY

Primary outcome measure

  • The mean number of Inflammatory Lesions on the face at the beginning and end of treatment [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

H G Berlin, ESQ

561-739-5252garyberlin17@hotmail.com

Locations

Palos Verdes Dermatology Associates

Recruiting

Rolling Hills Estates, California, United States, 90274

Contacts

Howard Fein, MD

310-541-7800

Principal Investigator:

HOWARD FEIN, MD

Berlin Center

Recruiting

Boynton Beach, Florida, United States, 33437

Contacts

H G Berlin, ESQ

561-739-5252garyberlin17@hotmail.com

Principal Investigator:

Joshua M Berlin, MD

More Information

Sponsor

Nexgen Dermatologics, Inc.

Last update posted

Feb 23, 2011

Last verified

Feb, 2011

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Nexgen Dermatologics, Inc. on 2011-02-23.