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Pharmacokinetics of Topical SB204 in Adolescents With Acne Vulgaris

N

Novan

Status and phase

Completed
Phase 1

Conditions

Acne Vulgaris

Treatments

Drug: SB204 4%

Study type

Interventional

Funder types

Industry

Identifiers

NCT02801903
NI-AC103

Details and patient eligibility

About

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

Full 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

Enrollment

18 patients

Sex

All

Ages

9 to 16 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

18 participants in 1 patient group

SB204 4%
Experimental group
Description:
Topically Once Daily (AM)
Treatment:
Drug: SB204 4%

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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