Clinical Evaluation of Deodorant Efficacy
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 to determine initial qualification. For 7 days prior to the Test Phase, 8/24/26) of the trial, subjects will receive a fragrance-free soap, supplied by the Testing Facility, and will be instructed to abstain from use of all deodorants, antiperspirants, perfumed/fragranced, or medicated products, and to use the fragrance-free soap for all bathing until completion of the trial. A Conditioning Phase daily diary will be provided to each subject to document each washing. The day prior to the Test Phase, subjects will wash both underarms with their fragrance-free soap in the morning only 8/23/26. Subjects will not wash their underarms during the rest of the day, evening nor in the morning of the Test Phase (8/24/26). Visit 2: Subjects will report to the Testing Facility with underarms unwashed, wearing a sleeveless shirt for evaluations. The underarms will be visually examined by an Expert Grader for redness, swelling, and dryness, or any other abnormalities. One Expert Odor Evaluator will subjectively and independently evaluate underarm odor, using a 0-to-10 point scoring scale for odor intensity (Unpleasant Perspiration 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 not smoke or eat at least 1 hour prior to odor evaluations. The Expert Odor Evaluator will independently and privately evaluate the underarm odor of each subject, one at a time, as the subjects file by at brief intervals, in random order. Prior to the Expert Odor Evaluations, subjects will be instructed to tightly hold their right and left arms against their sides. During all odor evaluations, the subject will elevate alternately the left arm and right arm to an almost vertical position. As the arm is elevated, the Expert Odor Evaluator will evaluate the odor first for the left underarm area by placing the nose 2 to 3 inches from the underarm surface. Each underarm will be evaluated and scored by the Expert Odor Evaluator alternating sniffing evaluations from one underarm to the other. As each underarm is being evaluated, the Expert Odor Evaluator will state the arm being evaluated and 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 in each underarm by the Expert Odor Evaluator. These assigned scores represent the initial readings for the odor evaluations (Baseline Scores). In order to avoid olfactory fatigue, odor evaluations will take place during periods of approximately 15 minutes, followed by at least a 5-minute recess, before the Expert Odor Evaluator proceeds with the next set of evaluations. If necessary, the same procedure can again be followed after 15 minutes of axillary odor evaluations. Immediately after pre-treatment (baseline) evaluations, qualified subjects will receive randomized application of the test material conducted by a trained technician. The test material will be applied directly from the container to the underarm. Containers will be weighed prior to and post-application to ensure the appropriate amount of the test material has been applied. Approximately half of the subjects will receive test material to the left underarm, while the right underarm will remain untreated. The remaining subjects will receive the reverse application allocation. The order of application will follow a randomization developed by the Testing Facility. Subjects will also be visually examined for evidence of redness, swelling, dryness and any abnormalities approximately 2 minutes post-application. In addition, odor evaluations will be completed, as previously described. Any post-treatment adverse effects in or around the underarms will be recorded. Subjects will be instructed to avoid washing or wetting their underarms (i.e., during bathing or showering) and to abstain from the use of any antiperspirant or deodorants until completion of the trial. Subjects will be required to wear the same clothing (a sleeveless shirt) at all evaluations. Subjects will be discontinued from the trial if they present with any level of fragrance on their clothing. If a sleeveless shirt is not worn, the shirt will be removed, and the subject will be issued a sleeveless paper cape to wear. Visit 3 (Day 2): Approximately 48 hours post-application, subjects will return to the Testing Facility wearing a sleeveless shirt. Both underarms will be visually examined by a clinical technician for redness, swelling and dryness, or any other abnormalities, as previously described. Following visual evaluations, odor evaluations for the subjects will be conducted by the Expert Odor Evaluator, as previously described. Visit 4: Approximately 72 hours post-application, subjects will return to the Testing Facility wearing a sleeveless shirt. Both underarms will be visually examined by a clinical technician for redness, swelling and dryness, or any other abnormalities, as previously described Following visual evaluations, odor evaluations for the subjects will be conducted by the Expert Odor Evaluator, as previously described. Subjects will then be dismissed. **After subjects have been qualified and test material has been applied, subjects will not be permitted to use antiperspirants, deodorants, wash, wet or shave their underarms until after the final 72 hr. odor evaluation has been conducted on 8/27/26.
70 New Dutch Lane, Fairfield, NJ
973-359-5879
Monday - Thursday: 7:30AM - 7:30PM
Friday: 7:30AM - 7:00PM
$10 if you do not qualify for visit 2.