Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 89 of 293 for:    acne AND moderate

Pharmacokinetics of Topical SB204 in Adolescents With 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.
 
ClinicalTrials.gov Identifier: NCT02801903
Recruitment Status : Completed
First Posted : June 16, 2016
Last Update Posted : October 12, 2018
Sponsor:
Collaborator:
WCCT Global
Information provided by (Responsible Party):
Novan, Inc.

Brief Summary:
A Phase 1, Single-center, Open-label, Pharmacokinetic, Safety and Tolerability Study of SB204 in Adolescents with Moderate to Severe Acne Vulgaris

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: SB204 4% Phase 1

Detailed Description:
This is a single-center, open-label study to be conducted in 18 otherwise healthy adolescents with moderate to severe acne vulgaris. Repeat blood samples will be obtained on Day 1 and Day 21 pre and post treatment to characterize systemic exposure to hMAP3 and nitrate. Subjects will receive a low-nitrate diet for 12 hours prior to and during the PK sampling period

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Single-center, Open-label Pharmacokinetic, Safety and Tolerability Study of SB204 in Adolescents With Moderate to Severe Acne Vulgaris
Actual Study Start Date : June 7, 2016
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 25, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: SB204 4%
Topically Once Daily (AM)
Drug: SB204 4%
Topically Once Daily (AM)
Other Name: NVN1000




Primary Outcome Measures :
  1. Pharmacokinetics of hMAP3 as measured by the maximum observed plasma concentration [ Time Frame: Day 21 ]
    Maximum plasma concentration of plasma hMAP3 on Day 21

  2. AUC - area under the plasma concentration time curve for hMAP3 [ Time Frame: Day 21 ]
    AUC; area under the plasma concentration time curve from t=0 to the last measurable concentration for plasma hMAP3 on Day 21


Secondary Outcome Measures :
  1. Pharmacokinetics as measured by maximum concentration of nitrate [ Time Frame: Day 21 ]
    Cmax: maximum plasma concentration of plasma nitrate on Day 21

  2. Pharmacokinetics (AUC) - area under the plasma concentration time curve for hMAP3 [ Time Frame: Day 21 ]
    AUC; area under the plasma concentration time curve from t=0 to the last measurable concentration for plasma nitrate on Day 21

  3. Safety profile (Reported adverse events) [ Time Frame: Day 21/End of Treatment ]
    Reported adverse events

  4. Tolerability (Scores on tolerability assessment) [ Time Frame: Day 21/End of treatment ]
    Scores on tolerability assessment during treatment



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   9 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Otherwise healthy male and female adolescent subjects with moderate to severe acne vulgaris on a 5 point IGA scale
  • At least 20 total inflammatory lesions (papules and pustules), and at least 20 total non-inflammatory lesions (open and closed comedones) on the face, chest, back, and shoulders
  • Age 9-16 years, 11 months inclusive
  • Subjects with methemoglobin level less than 3% at Screening and Baseline by pulse co-oximeter

Exclusion Criteria:

  • Subjects with any other acne-like dermatological conditions such as severe, recalcitrant nodulocystic acne, acne conglobata, acne fulminans, acne secondary to medications or other medical conditions, perioral dermatitis, clinically significant rosacea, or gram-negative folliculitis;
  • Any subject with skin disorders of an acute or chronic nature including psoriasis, eczema, tinea versicolor, etc.
  • Subjects who reside in a dwelling that relies on well water for a primary drinking source
  • Subjects with facial hair (beards, mustaches, etc.), tattoos or other facial markings that would interfere with assessments and study drug application
  • Transgender subjects receiving hormone supplement (male to female or female to male)
  • Subjects with a previous history of methemoglobinemia or taking medications known to be associated with methemoglobinemia
  • Subjects with a known history of HIV, hepatitis, or other blood-borne pathogens
  • Females who are pregnant, planning a pregnancy or breastfeeding
  • Subjects previously treated with NVN1000 Gel / SB204

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 ClinicalTrials.gov identifier (NCT number): NCT02801903


Locations
Layout table for location information
United States, Texas
WCCT #1
Austin, Texas, United States, 78759
Sponsors and Collaborators
Novan, Inc.
WCCT Global
Investigators
Layout table for investigator information
Study Director: M. Joyce Rico, MD Novan, Inc.

Layout table for additonal information
Responsible Party: Novan, Inc.
ClinicalTrials.gov Identifier: NCT02801903     History of Changes
Other Study ID Numbers: NI-AC103
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases