P318-22 ADV. MALE INTIMATE POST-SHAVE BALM FOR MEN AGES 18 TO 54


P318-22 ADV. MALE INTIMATE POST-SHAVE BALM FOR MEN AGES 18 TO 54
Posted  November 18, 2022

START DATE12/02/2022
QUALIFICATIONSMen Ages 18 to 54 with sensitive skin
TIME REQUIREMENT3 Visits
COMPENSATION$100

NOTES: 

  • Subject has self-perceived sensitive skin.
  • Subject shaves their pubic region with a wet razor at least once per week.
  • Subject agrees to continue to wet shave their pubic region at least once per week with their current razor and shave prep.
  • No other studies for the male intimate area (pubic region).
  • Subject cannot have known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs.
  • Masks are optional while at Eurofins|CRL. If you do wear a mask, you must remove it when requested.
  • Children are not allowed in the facility for visits longer than 20 minutes.

Please read Full Inclusion and Exclusion Criteria below carefully.

Study Hours: 7:30 a.m. to 5 p.m.
Visit 1: 
Baseline – Friday, 12/2 – 20 minutes
Visit 2: 
Week 2 – Friday, 12/16 – 20 minutes
Visit 3: 
Final – Friday, 12/30 – 20 minutes

Inclusion Criteria:
a. Subject is male, ages 18-54.
b. Subject has self-perceived sensitive skin (100% of the study population).
c. Subject is of any Fitzpatrick (recorded in the demographics).
d. Subject is of any ethnicity (recorded in the demographics).
e. Subject exhibits no edema, no greater than barely perceptible (±) erythema, and no greater than slight (1) dryness of the test sites at baseline.
f. Subject shaves their pubic region with a wet razor at least once per week.
g. Subject agrees to continue to wet shave their pubic region (mons pubis, upper thigh/perigenital area, or scrotum) at least once per week with their current razor and shave prep.
h. Subject is willing to replace any post-shave moisturizer/balm/lotion with the test product.
i. Subject agrees not to introduce any new body products for the duration of the study (e.g., shampoo, body washes/soaps, shave preps etc.).
j. Subjects agrees to purchase and continue using the exact same brand and type of products they are currently using should they run out during the study.
k. Subject is willing to use the test product daily and wear the product for a minimum of 8 hours a day.
l. Subject agrees not to introduce any new cosmetic or toiletry products during the study.
m. Subject is dependable and able to follow directions as outlined in the protocol.
n. Subject is willing to participate in all study evaluations.
o. Subject is in generally good health and has a current Panelist Profile Form on file at CRL.
p. Subject has completed a HIPAA Authorization Form in conformance with 45 CFR Parts 160 and 164.
q. Subject understands and is willing to sign an Informed Consent Form in conformance with 21 CFR Part 50: “Protection of Human Subjects.”

Exclusion Criteria:
a. Subject has received treatment with sympathomimetics, antihistamines, vasoconstrictors, non-steroidal anti-inflammatory agents, and/or systemic or topical corticosteroids within one week prior to initiation of the study.
b. Subject has a history of acute or chronic dermatologic, medical, and/or physical conditions which would preclude application of the test material and/or could influence the outcome of the study.
c. Subject is currently taking certain medications which, in the opinion of the Principal Investigator, may interfere with the study.
d. Subject has known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs.
e. Subject has a history of skin cancer, or is currently undergoing treatment for active cancer of any kind.
f. Subject has insulin-dependent diabetes.




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