Evaluation of a Dry Shampoo
If you are eligible for the study and you choose to participate, you will:
PROCEDURES: Visit 1: Potential subjects will report to the Testing Facility at their scheduled appointment time and complete an ICF to become subjects. Subjects will complete a Medical History Form and a Baseline Qualification hair questionnaire to determine initial qualification. Subjects will be instructed to wash their hair once on Day-3 and to not wash or wet their hair again for the trial duration. They will also be instructed to avoid applying any products to their hair, hairline (including forehead), and scalp (with the exception of the test material), and to abstain from the use of all perfumes, fragranced, and medicated products for the trial duration. Visit 2 (Day 0): Subjects will report to the Testing Facility at their scheduled appointment time without having applied any products to their hair, hairline (including forehead), and scalp. Subjects will be asked if they currently have self-perceived oily or greasy roots. An Expert Grader will examine each subject’s scalp and hairline for evidence of redness, swelling, and dryness. Any subject exhibiting a score of ≥ 2 for any one parameter will be disqualified. One Expert Odor Evaluator will subjectively and independently evaluate scalp odor, using a 0-to-10-point scoring scale for odor intensity (Unpleasant Odor). Subjects presenting any level of pleasant odor (e.g., fragrance) detected by the Expert Odor Evaluator during the qualification procedure, indicating non-compliance with the written instructions, will not qualify. The Expert Odor Evaluator will evaluate the odor by placing the nose 2 to 3 inches from the scalp and provide the score for the odor evaluation. Final qualification of subjects will be achieved only if pre-treatment odor scores of at least “3” (based upon 0-10 odor evaluation scale above) are perceived by the Expert Odor Evaluator. Qualified subjects will equilibrate in the temperature controlled room for at least 30 minutes. Following equilibration, baseline sebum measurements will be captured at the test site, as previously described. Under clinical supervision, subjects will apply the test material according to the Sponsor-supplied use instructions. Subjects will be instructed to continue to refrain from washing or wetting their hair for the remainder of the trial. Subjects must also continue to avoid applying any products to their hair, hairline (including forehead), and scalp and to abstain from the use of all perfumes, fragranced, and medicated products for the trial duration. Subjects may not introduce any new cosmetic, toiletry, or personal care products during the trial. Subjects may not participate in any intense physical activity or activities that cause sweating (saunas, hot tubs, etc.) for the trial duration. Following test material application, subjects will continue to equilibrate in the temperature controlled room for at least 30 minutes. Following equilibration, odor evaluations will be conducted, and sebum measurements will be captured at the test site, as previously. Subjects will be administered a Sponsor-supplied questionnaire to complete. The questionnaire will be reviewed for completeness prior to subjects’ dismissal. Visit 3 (Day 1): Approximately 24 hours post application, subjects will report to the Testing Facility at their scheduled appointment time. Expert odor evaluations will be conducted, as previously described. Subjects will equilibrate in the temperature-controlled room for at least 30 minutes, as previously described. While equilibrating, subjects will be administered a Sponsor-supplied questionnaire to complete. The questionnaire will be reviewed for completeness prior to subjects’ dismissal. Following equilibration, Sebumeter® measurements will be captured at the test site, as previously described. Subjects will then be dismissed.
70 New Dutch Lane, Fairfield, NJ
973-359-5879
Monday - Thursday: 7:30AM - 7:30PM
Friday: 7:30AM - 7:00PM
If you do not qualify at visit 2, you will receive $10.