ADVANCED CLINIC P223 Pediatric Foaming Hand Soap Study for Teens – 2 Groups

Pediatric Foaming Hand Soap Study for Teens 

Inclusion criteria:

• Subject is male or female
• Subject is ages 8 to 17 years of age
• Subject has self-perceived non-sensitive skin
• Subject exhibits no edema, no greater than barely perceptible (±) erythema, and no greater than slight (1) dryness of the test sites at baseline. 
• Subject agrees to avoid excessive sun exposure and the use of artificial tanning methods.
• Subjects agrees to discontinue use of their current hand soap and only use the product provided for all hand washing needs at home during the course of the study.
• Subject’s parent/legal guardian agrees to refrain from applying any other products to the test sites, other than the provided test material, for the duration of the study. 
• Subject’s parent/legal guardian agrees not to introduce any new cosmetic or toiletry products during the study. 
• Subject’s parent/legal guardian is dependable and able to follow directions as outlined in the protocol and anticipates being available for all study visits. 
• Subject’s parent/legal guardian allows the subject to participate in all study evaluations. 

Exclusion criteria:

• Female subject (for those of age) is pregnant, nursing, planning a pregnancy, or not using adequate birth control. 
• 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.
• Subject has a history of acute or chronic dermatologic, medical, and/or physical conditions which would, in the opinion of the Principal Investigator, preclude application of the test material and/or could influence the outcome of the study. 
• Subject is currently taking certain medications which, in the opinion of the Principal Investigator, may interfere with the study. 
• Subject has known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs. 
• Subject has a history of skin cancer or is currently undergoing treatment for active cancer of any kind. 
• Subjects who are currently under the treatment for asthma and are currently taking medication (inhaler, breathing treatments). 
• Subject has insulin-dependent diabetes. 
• Subjects who are currently participating in a clinical research study or who have participated in a clinical study within the last seven (7) days. 

Study Groups and Dates: 

Group 1

V1   Tues.    9/10    20 min.

Tues.    9/24   no lab visit – mid study call in

V2   Tues.   10/08   20 min.

Group 2

V1   Fri.    9/13    20 min.

Fri.    9/27   no lab visit – mid study call in

V2   Fri.   10/11   20 min.