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Status unknownNCT01301586Updated Feb 23, 2011

A Novel Combination Oral Agent to Treat Acne Vulgaris

A Phase 1/2 interventional study of Doxycycline and S-equol and Doxycycline in ACNE VULGARIS, sponsored by Nexgen Dermatologics, Inc.. Status unknown at 2 sites in United States. Open to female participants aged 13 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-02-23.

Sponsored by Nexgen Dermatologics, Inc. · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2011), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
13 Years to 60 Years
Sex
Female
01

Study summary

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

02

Conditions studied

  • ACNE VULGARIS

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03

In context

Acne Vulgaris

730 studies on the registry are indexed under Acne Vulgaris; 86 are open to participants now.

This study's planned enrollment of 60 is below the median of 69 across 628 interventional studies indexed under Acne Vulgaris.

Browse Acne Vulgaris studies →

Lead sponsor

Nexgen Dermatologics, Inc. is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years to 60 Years
Sexes eligible
Female
Accepts 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

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Oral antibiotic plus soy extract

    Drug: Doxycycline and S-equol

  • Active comparator
    Oral antibiotic

    Drug: Doxycycline

Interventions

  • DrugDoxycycline and S-equol

    Oral doxycycline and s-equol twice a day

  • DrugDoxycycline

    ORAL DOXYCYCLINE TWICE A DAY

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 weeks

Secondary outcomes

  1. 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.

    Time frame: 12 weeks

07

Study locations

2 of 2 sites recruiting
  • Palos Verdes Dermatology Associates
    Rolling Hills Estates, California 90274, United States
    • Howard Fein, MD · Contact · 310-541-7800
    • HOWARD FEIN, MD · Principal investigator
    Recruiting
  • Berlin Center
    Boynton Beach, Florida 33437, United States
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01301586
Lead sponsor
Nexgen Dermatologics, Inc.
First posted
Feb 23, 2011
Start date
Nov 2010
Primary completion
Sep 2011 (estimated)
Completion
Sep 2011 (estimated)
Last update
Feb 23, 2011

Study contacts

H G Berlin, ESQ
Contact
garyberlin17@hotmail.com
561-739-5252
Joshua M Berlin, MD
principal investigator · Study Protocol, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.

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Discussion

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