Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2025-12-24 @ 7:39 PM
NCT ID:
NCT02801903
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
9 Years
Maximum Age:
16 Years
Study:
NCT02801903
Study Brief:
Protocol Section:
NCT02801903