Study of NVN1000 Topical Gel and Topical Gel Vehicle in the Treatment of Moderate to Severe Acne Vulgaris

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novan, Inc.
ClinicalTrials.gov Identifier:
NCT01556698
First received: March 14, 2012
Last updated: March 15, 2012
Last verified: March 2012
  Purpose

The primary objective of this study is to compare the tolerability, safety and efficacy of NVN1000 Topical Gel and Topical Gel Vehicle in the treatment of subjects with moderate to severe acne vulgaris.


Condition Intervention Phase
Acne Vulgaris
Acne
Drug: NVN1000 Topical Gel
Drug: Topical Gel Vehicle
Phase 1
Phase 2

Study Type: Interventional

Resource links provided by NLM:


Further study details as provided by Novan, Inc.:

Study Start Date: July 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NVN1000 Topical Gel Drug: NVN1000 Topical Gel
Placebo Comparator: Topical Gel Vehicle Drug: Topical Gel Vehicle
Placebo

  Eligibility

Ages Eligible for Study:   12 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Baseline IGA score of moderate (3) or severe (4)
  • Minimum of 20 but no more than 40 facial inflammatory lesions
  • Minimum of 20 but not more than 60 facial non-inflammatory lesions
  • No more than 2 facial nodules

Exclusion Criteria:

  • Dermatological conditions on the face that could interfere with clinical evaluations
  • Underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive
  • History of experiencing significant burning or stinging when applying any facial treatment
  • Female subjects, if they are pregnant,nursing mothers, or planning to become pregnant during the study
  • Have used estrogens or oral contraceptives for less than 90 days immediately preceding the Baseline visit, discontinued use of estrogens or oral contraceptives less than 90 days prior to Baseline,or planning to begin or discontinue use of this therapy during the treatment period
  • Have used medications and/or vitamins which are reported to exacerbate acne during the 180 days immediately preceding the Baseline visit
  • Use concomitantly over-the-counter (OTC) products that contain ingredients such as benzoyl peroxide,salicylic acid,alpha-hydroxy acid,retinol or glycolic acids
  • Have not undergone the specified washouts for topical preparations,systemic medications and procedures noted in the protocol
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01556698

Locations
Dominican Republic
Instituto Dermatologico
Santo Domingo, Dominican Republic
Sponsors and Collaborators
Novan, Inc.
Investigators
Principal Investigator: Daisy Blanco, MD Instituto Dermatológico
  More Information

No publications provided

Responsible Party: Novan, Inc.
ClinicalTrials.gov Identifier: NCT01556698     History of Changes
Other Study ID Numbers: NI-AC001
Study First Received: March 14, 2012
Last Updated: March 15, 2012
Health Authority: Dominican Republic: Consejo Nacional de Bioetica en Salud

Keywords provided by Novan, Inc.:
Acne Vulgaris
Acne

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases

ClinicalTrials.gov processed this record on August 20, 2014