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Clinical Trials/NCT01301586
NCT01301586
Unknown
Phase 1

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

Nexgen Dermatologics, Inc.2 sites in 1 country60 target enrollmentNovember 2010
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ConditionsACNE VULGARIS
InterventionsDoxycycline and S-equolDoxycycline
DrugsDoxycycline and S-equolDoxycycline

Overview

Phase
Phase 1
Intervention
Doxycycline and S-equol
Conditions
ACNE VULGARIS
Sponsor
Nexgen Dermatologics, Inc.
Enrollment
60
Locations
2
Primary Endpoint
The mean number of Inflammatory Lesions on the face at the beginning and end of treatment
Last Updated
15 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
November 2010
End Date
September 2011
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Eligibility Criteria

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

Arms & Interventions

Oral antibiotic plus soy extract

Intervention: Doxycycline and S-equol

Oral antibiotic

Intervention: Doxycycline

Outcomes

Primary Outcomes

The mean number of Inflammatory Lesions on the face at the beginning and end of treatment

Time Frame: 12 weeks

The number of inflammatory lesions will be counted by a trained investigator at the beginning and end of treatment.

Secondary Outcomes

  • The mean number of Comedones will be evaluated at the beginning and end of treatment(12 weeks)

Study Sites (2)

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