Pre-Teen/Teen Acne Serum Study for Self-Perceived/Parent Perceived Acne Prone Skin

PROCEDURES:

Visit 1: Potential subjects will report to the Testing Facility with a clean face, at their scheduled appointment time. Subjects aged 8 – 17 will execute an Adolescent Assent Form after their parent/legal guardian has executed an ICF. Subjects aged 18 will complete an ICF to become subjects. A Medical History Form will be completed to determine initial qualification, and subject demographics will be collected.

A Board-Certified Dermatologist will evaluate each subject’s face for evidence of redness, swelling, and dryness. Subjects presenting a score of 2 or greater for at least one parameter will be disqualified. All evaluation scores will be recorded on CRFs. Qualified subjects will be provided with a 4-week supply of the pre-weighed test material and a daily diary to document use. Subjects will be provided written and verbal instructions for use and restrictions, supplied by the Sponsor.

Parent/legal guardians may not introduce any new cosmetic, toiletry, or personal care product into the child’s (the subject’s) routine during the trial.

Visit 2:

After 4 weeks of test material use, subjects will report to the Testing Facility with a clean face, at their scheduled appointment time. Subjects under 18 must be accompanied by their parent/legal guardian. Any unused test material and completed daily diaries will be returned. Diaries will be reviewed for compliance. Test materials will be reweighed.

The Board-Certified Dermatologist will conduct a final evaluation of each subject’s face for evidence of redness, swelling, and dryness. Subjects will then be dismissed.