P336-22 BIO ANTI-GREY HAIR STUDY FOR MEN & WOMEN AGES 18 TO 55


P336-22 BIO ANTI-GREY HAIR STUDY FOR MEN & WOMEN AGES 18 TO 55
Posted  November 16, 2022

START DATE12/19/2022
QUALIFICATIONSMen & Women Ages 18 to 55
TIME REQUIREMENT5 Visits
COMPENSATION$450

NOTES: PRESCREENING IS REQUIRED with clean product-free hair.

  • Subjects must have at least 20-50% gray hair.
  • Subjects must maintain minimum of 3 inch hair length throughout the study.
  • Each subject must have natural, virgin hair over the last 3 months before the study start date.
  • Subjects must not have hair loss conditions or are undergoing treatment that could result in hair loss, alopecia, etc.
  • Subjects must undergo no hair coloring/treatment/mask or use functional shampoos within 2 months prior to the study start date, during the course of the conditioning phase and throughout the course of the study period.
  • No other hair studies while on this study.
  • Subject must sign a photography release form.
  • Masks are optional while at Eurofins|CRL. If you do wear a mask, you must remove it when requested for acclimation & photos.
  • Children are not allowed in the facility for visits 20 minutes or longer.

Please read Full Inclusion and Exclusion Criteria below carefully.

Study Hours:  8:40 a.m. to 12:20 p.m. & 2 to 3:40 p.m.

GROUP 1: (will keep the same appointment time for all visits)
V1:  Pickup/Baseline – Monday, 12/19 – 1.5 hours
V2: 
Week 4 – Monday, 1/16 – 1 hour
V3: 
Week 8 – Monday, 2/13 – 1 hour
V4:  Week 12 – Monday, 3/13 – 1 hour
V5:  Week 16 – Monday, 4/10 – 1 hour

GROUP 2: (will keep the same appointment time for all visits)
V1:  Pickup/Baseline – Tuesday, 12/20 – 1.5 hours
V2: 
Week 4 – Tuesday, 1/17 – 1 hour
V3: 
Week 8 – Tuesday, 2/14 – 1 hour
V4:  Week 12 – Tuesday, 3/14 – 1 hour
V5:  Week 16 – Tuesday, 4/11 – 1 hour

GROUP 3: (will keep the same appointment time for all visits)
V1:  Pickup/Baseline – Wednesday, 12/21 – 1.5 hours
V2: 
Week 4 – Wednesday, 1/18 – 1 hour
V3: 
Week 8 – Wednesday, 2/15 – 1 hour
V4:  Week 12 – Wednesday, 3/15 – 1 hour
V5:  Week 16 – Wednesday, 4/12 – 1 hour

Inclusions:
1. Subject is female or male between 18 and 55 years of age;
2. Study must finish with n=10 subjects in each of the Andre Walker Hair Types, I-IV.
3. Each subject must have at least 20-50% gray hair.
4. Subjects with all hair colors.
5. Study must finish with a minimum of n=7 subjects with red and blonde hair colors with minimum n=3 for each color; both red and blonde hair subjects can be recruited from any of the Walker Hair Types I-IV.
6. Subjects must maintain minimum of 3” hair length throughout the conditioning phase and throughout the course of the study.
7. Each subject must have natural, virgin hair over the last 3 months before the study start date.
8. Subject agrees not to introduce any new cosmetic or toiletry products to the testing site, during the study, like shampoo or conditioner;
9. Subject is dependable and able to follow directions as outlined in the protocol and anticipates being available for all study visits;
10. Subject is willing to participate in all study evaluations;
11. Subject is in generally good health and has a current Panelist Profile Form on file at CRL;
12. Subject agrees to sign a Photography Release Form and Model Release Form, providing consent for the capture of digital images for use in relation to this clinical study;
13. Subject has completed a HIPAA Authorization Form in conformance with 45 CFR Parts 160 and 164;
14. Subject understands and is willing to sign an Informed Consent Form in conformance with 21 CFR Part 50: “Protection of Human Subjects.”

Exclusions:
1. Subject is pregnant, nursing, planning a pregnancy, or not using adequate birth control;
2. Subjects with hair loss conditions or who are undergoing treatment that could result in hair loss, alopecia, etc.
3. Subjects must undergo no hair coloring/treatment/mask or use functional shampoos (shampoos TBD by sponsor) within 2 months prior to the study start date, during the course of the conditioning phase and throughout the course of the study period.
4. 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;
5. Subject has known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs;
6. 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;
7. Subject exhibits irritation, tattoos, sunburn, rashes, scratches, burn marks, scarring, etc. on the test sites, which might interfere with evaluations of test results;
8. Subject is currently taking any medications which, in the opinion of the Principal Investigator, may interfere with the study;
9. Subject has known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs;
10. Subject has a history of skin cancer, or is currently undergoing treatment for active cancer of any kind;
11. Subject has diabetes.




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