A Novel Combination Oral Agent to Treat Acne Vulgaris

Nexgen Dermatologics

Status and phase: Unknown; Phase 2; Phase 1

Conditions: ACNE VULGARIS

Treatments: Drug: Doxycycline; Drug: Doxycycline and S-equol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01301586

11022006

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: Female

Ages: 13 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Oral antibiotic plus soy extract

Active Comparator group

Treatment:

Drug: Doxycycline and S-equol

Oral antibiotic

Active Comparator group

Treatment:

Drug: Doxycycline