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Trial record 46 of 164 for:    acne AND Vehicle

A 2 Period Cross-over Pharmacokinetic Study of SB204 in Acne Vulgaris

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02164084
Recruitment Status : Completed
First Posted : June 16, 2014
Last Update Posted : April 3, 2015
Information provided by (Responsible Party):
Novan, Inc.

Brief Summary:
This study will identify how much (if any) drug is absorbed from the skin of subjects with acne vulgaris after topical application of SB204.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: SB204 Drug: Vehicle Gel Phase 1

Detailed Description:
This is a single-center, double-blind, randomized, 2 period cross-over study to be conducted in 18 subjects (18 years of age and above) each of whom will receive SB204 8% and Vehicle Gel. Subjects who satisfy the entry criteria will be randomized to SB204 8% or Vehicle Gel in a 1:1 ratio for the first treatment period. Study drug will be applied to the face, upper chest, upper back and shoulders (approximately 17% BSA) twice daily on Days 1- 4 approximately 12 hours apart. On Day 5, the study drug will be applied to the same areas only once, in the morning. Pharmacokinetic (PK) profiling will be performed on Day 1 and Day 5. After a wash out period, subjects will be treated with the alternate product and undergo similar treatment and assessments. The primary assessment is the pharmacokinetic profile of nitrate and silicon as markers for systemic exposure to nitric oxide (nitrate) and NVN1000 (silicon) after topical application of SB204 8% to approximately 17% of the total body surface area.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1, Single-center, Double-blind, Randomized, Cross-over, Pharmacokinetics, Safety and Tolerability Study of SB204 8% (NVN1000 Gel) and Vehicle Gel
Study Start Date : June 2014
Actual Primary Completion Date : June 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: SB204
SB204 8% topically twice daily for 4 days and once on Day 5
Drug: SB204
SB204 Gel with hydrogel
Other Name: NVN1000

Placebo Comparator: Vehicle Gel
Vehicle Gel topically twice daily for 4 days and once on Day 5
Drug: Vehicle Gel
Vehicle Gel with hydrogel

Primary Outcome Measures :
  1. Pharmacokinetics of nitrate and silicon [ Time Frame: After single dose and multiple dose (Day 5) application ]
    Standard PK parameters including area under the curve (AUC) 0-∞, AUC0-t, Cmax, Cmin, and T1/2, for nitrate and silicon. Calculations may be based on actual and/or baseline-subtracted concentrations for nitrate.

Secondary Outcome Measures :
  1. Safety [ Time Frame: Safety will be assessed throughout the study duration (up to 7 weeks). ]
    Physical examinations including vital signs, EKGs, and laboratory assessments (serum chemistry, hematology and urinalysis) will be performed at Screening and during the study. Adverse events will be collected throughout the study.

Other Outcome Measures:
  1. Tolerability [ Time Frame: During both treatment periods, through last day of treatment. ]
    During the study, cutaneous tolerability assessments will be made at Day 1 and at the end of each treatment period (Day 5). Erythema, dryness, scaling, stinging/burning and itching will be assessed on a four point scale where 0 = none, 1 = mild, 2 = moderate, and 3 = severe.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male and female subjects with an acne severity of moderate or severe and a minimum of 20 inflammatory and 20 non-inflammatory lesions on the face, trunk and shoulders
  • 18 years of age and older

Exclusion Criteria:

  • Any subject with skin disorders of an acute or chronic nature including psoriasis, eczema, tinea versicolor, etc.
  • Subjects who smoke or use tobacco products
  • Subjects with methemoglobin level greater than 2% at Screening or Baseline by pulse co-oximeter.
  • Subjects with a previous history of methemoglobinemia
  • Subjects being treated with nitrates or any drug associated with methemoglobinemia
  • Subjects with a known history of HIV, hepatitis, or other blood-borne pathogens.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02164084

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United States, Wisconsin
Spaulding Clinical Research, LLC
West Bend, Wisconsin, United States, 53095
Sponsors and Collaborators
Novan, Inc.
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Principal Investigator: Carlos Sanabria, MD Spaulding Clinical Research LLC

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Responsible Party: Novan, Inc. Identifier: NCT02164084     History of Changes
Other Study ID Numbers: NI-AC101
First Posted: June 16, 2014    Key Record Dates
Last Update Posted: April 3, 2015
Last Verified: April 2015
Keywords provided by Novan, Inc.:
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases