A Novel Combination Oral Agent to Treat Acne Vulgaris

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

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01301586

Enrollment

Registered

2011-02-23

Start date

2010-11-30

Completion date

2011-09-30

Last updated

2011-02-23

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

Conditions

ACNE VULGARIS

Brief summary

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

Interventions

DRUGDoxycycline and S-equol

Oral doxycycline and s-equol twice a day

DRUGDoxycycline

ORAL DOXYCYCLINE TWICE A DAY

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

13 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Contacts

Primary ContactH G Berlin, ESQ

garyberlin17@hotmail.com561-739-5252

Outcome results

None listed

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