Posted  March 19, 2021

START DATE04/06/2021
QUALIFICATIONSMen & Women Ages 18 to 65, with dry, flaking scalp

NOTES: PRESCREENING IS REQUIRED – Must have mild to moderate dandruff / flakes in hair.
* Will need to wash hair every other day while on study.
* You must wear a face mask/covering while at ECRL except when required to remove it for photographs.

*Children, purses and other personal bags are not permitted in the facility at this time.

Study Hours:  8 a.m. to 4 p.m. – All visits are the same appointment times.
Group 2:
Visit 1: Wednesday, April 7th – 1.5 hours
Visit 2: Friday, April 16th – 45 min.
Visit 3: Tuesday, April 27th – 45 min.

Group 3:
Visit 1: Tuesday, April 13th – 1.5 hours
Visit 2: Thursday, April 22nd – 45 min.
Visit 3: Friday, May 3rd – 45 min.

Group 4:
Visit 1: Tuesday, April 20th – 1.5 hours
Visit 2: Thursday, April 29th – 45 min.
Visit 3: Monday, May 10th – 45 min.

Group 5:
Visit 1: Wednesday, April 28th – 1.5 hours
Visit 2: Friday, May 7th – 45 min.
Visit 3: Tuesday, May 18th – 45 min.

Inclusion Criteria:

  • Subject is male (25%) or female (75%) between 18 and 65 years of age;
  • Subject has mild to moderate dandruff / flakes in hair;
  • Subject has refrained from using any anti-dandruff products 2 weeks prior to the beginning of the usage period;
  • Subject agrees to replace shampoo with test product and continue using regular conditioner throughout study;
  • Subject agrees not to introduce any new cosmetic or toiletry products during the study;
  • Subject agrees to discontinue use of dandruff treatments and anti-dandruff hair care products for the duration of the study;
  • Subject agrees not to get a haircut for the study duration;
  • Subject is dependable and able to follow directions as outlined in the protocol;
  • Subject is willing to participate in all study evaluations;
  • Subject is in generally good health and has a current Panelist Profile Form on file at CRL;
  • Subject agrees to sign a Photography Release Form, providing consent for the capture of digital images for use in relation to this clinical study;
  • Subject has completed a HIPAA Authorization Form in conformance with 45 CFR Parts 160 and 164;
  • Subject 18 years of age or older understands and is willing to sign an Informed Consent Form in conformance with 21 CFR Part 50: “Protection of Human Subjects”.

Exclusion Criteria:

  • Female subject 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 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 used anti-dandruff products in the last two weeks;
  • 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;
  • Subject has diabetes.

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