P245 Bio Acne Spot Treatment – Rolling Recruit – NEW DATES


P245 Bio Acne Spot Treatment – Rolling Recruit – NEW DATES
Posted  February 25, 2021

START DATE04/07/2021
QUALIFICATIONSMale/Female ages 13 through 40 African American, Hispanic/Latino, Asian/Indian/Pakistani/Pacific Rim, Caucasian
FITZPATRICK TYPES1 2 3 4 5 
TIME REQUIREMENT4 visits approximately 1 hour in duration - first 2 visits on the same day.
COMPENSATION$150

NOTES: ALL MINORS 13 TO 17 MUST BE ACCOMPANIED BY THEIR PARENT OR LEGAL GUARDIAN TO THE FIRST AND LAST STUDY VISIT.
* All minors, parents or guardians must wear a face mask/face covering to all study visits.
* Study participants must be willing to remove their masks for photos to be used with the study.
*Minor children other than the study participant are not permitted in the facility at this time.
* All study participants must be willing to
* Visits 1 and 2 will take place on the same date, 2 hours apart.  During this time, the subject MUST LEAVE the facility , to return 2       hours later.
* purses, other personal bags of any sort are not permitted in the facility at this time.
* All study participants must have Moderate acne on both sides of their face.
* all study participants MUST STOP USING their usual acne products 14 days prior to the start of this study.
* All study participants must be willing to sign a Model Photo release form  for the use of digital images in marketing materials and a QVC Affidavit
* Prescreening is required for this study.

Study Hours:  9 a.m. to 12 p.m.

Group 5: 
Visit 1:  Wednesday, 4/14 – 1.5 hours
Visit 2:  Wednesday (same day, 2 hours post application), 4/14 – 45 minutes
Visit 3:  Friday, 4/16 – 1 hour
Visit 4:  Wednesday, 4/28 – 1 hour

Group 6: 
Visit 1:  Tuesday, 4/20 – 1.5 hours
Visit 2:  Tuesday (same day, 2 hours post application), 4/20 – 45 minutes
Visit 3:  Thursday, 4/22 – 1 hour
Visit 4:  Tuesday, 5/4 – 1 hour

SPEAK WITH BIO REGARDING TIME CHANGES DUE TO SCHOOL ATTENDANCE

You MUST:

  • be male or female, 13 & 40 years of age, in general good health, with oily skin.
  • be Latino/Hispanic, Caucasian, African , Asian/Indian/Pakistani/Pacific Rim.
  • have moderate acne and visible pores; have or does not have fungal acne; may present with post-inflammatory hyperpigmentation (not all subjects need to have post-inflammatory hyperpigmentation); (yes or N/A)
  • have not used acne products 14 (+/3 days) prior to their baseline visit;
  • agree to remove face mask for the acclimation period (within socially distanced proximity of other subjects) and for study evaluations (including image captures), and to replace the face mask as directed by study staff;
  • agree not to introduce any new cosmetic or toiletry products during the study;
  • agree to discontinue use of current acne treatments, moisturizers and products with moisturizing ingredients for the conditioning phase and for the duration of the study;
  • be dependable and able to follow directions as given, be willing to participate in all study evaluations; be willing to sign a QVC Affidavit;
  • Subject and parent/legal guardian (as applicable) agrees to sign a Photography Release Form, providing consent for the capture of digital images for use in relation to this clinical study;
  • be willing to sign a Model Photo Release Form, providing consent for use of digital images in marketing materials;

You MUST NOT:

  • Female subject: be pregnant, nursing, planning a pregnancy, or using inadequate birth control;
  • have 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;
  • have a history of acute or chronic dermatologic, medical, and/or physical conditions which would preclude application of the test material or could influence the outcome of the study;
  • be currently taking certain medications which may interfere with the study;
  • be currently taking or has taken within the last 30 days oral or topical prescription medications for acne such as Doxycycline, Minocycline, Clindamycin, Bactrim, Tetracycline, Erythrocycin, Vibramycin and topical tretinoin (Retin A Renova, Adapalene, Tazarotene), Azelaic acid, benzoyl peroxide, Dapsone, Sodium sulfacetamide, Differin, Epiduo;
  • be currently taking or has taken within the last six months oral isotretinoin (Accutane);
  • have known sensitivity or allergy to cosmetics/toiletry products, salicylic acid, benzoyl peroxide, sulfur, and/or any topically applied medications;
  • have participated in any clinical study which involved the face within two weeks of study initiation;
  • have known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs.
  • have a history of skin cancer, or is currently undergoing treatment for active cancer of any kind;
  • have diabetes.

 

 




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