Safety Studies - Skin

Patch Tests (Sensitization, Irritation, Comedogenicity), Safety-In-Use, and Acne

Safety studies are designed to assess a product's potential to cause irritation/sensitization or acneform type effects under exaggerated (patch) or normal use conditions. After reviewing your responses, someone from RCTS will contact you. If you have any questions, please contact Barry Reece at 972-871-4371 (office), 972-841-2916 (cell), or by email at barry.reece@alsglobal.com.

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* 1. Please tell us how we can contact you:

Name

Company

Address

Address 2

City/Town

State/Province

ZIP/Postal Code

Country

Email Address

Phone Number

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* 2. Your company's website:

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* 3. Product Category: Please choose as many of interest to you.

Cosmetic - Skin Care

Cosmetic - Color (makeup, eye area)

Hair Care

Baby Care (Shampoos, lotions, wipes, etc.)

Drug (IND, Prescription) - Dermatological/Topical

Drug (IND, Prescription) - Other (describe below)

Drug (OTC) - Dermatological/Topical

Drug (OTC) - Other (describe below)

Antimicrobial Handwash

Medical Device

Feminine Hygiene

Other (please specify)

Question Title

* 4. Human Repeat Insult Test (HRIPT)/Photosensitization. Check all that apply.

Protocol: Modified Draize

Protocol: Jordan-King

Shared Studies

Exclusive Studies

Skin Type: Normal Skin

Skin Type: Sensitive Skin

Number (N) of Subjects = 50

Number (N) of Subjects = 100

Number (N) of Subjects = 200

Standard Number of Photoirritation/Photosensitization Subjects (25 )

Different protocol or number of subjects than shown above. Someone from RCTS will contact you to discuss.

Questions or Comments:

Question Title

* 5. Cumulative Irritation Test (CIT)

Skin Type: Normal Skin

Skin Type: Sensitive Skin

Standard Number of Subjects (25)

Custom designed CIT. Someone from RCTS will contact you to discuss.

Questions or Comments

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* 6. Acute Irritation

Skin Type: Normal Skin

Skin Type: Sensitive Skin

Standard Number of Subjects (25 )

Custom designed Acute Irritation Test. Someone from RCTS will contact you to discuss.

Questions or Comments

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* 7. Comedogenicity

Number of Subjects (Standard Number of Subjects = 15)

Questions or Comments

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* 8. Safety-In-Use Study Options: Please choose all that apply

Dermatological (Standard Number of Subjects = 30)

Ophthalmological (Standard Number of Subjects = 30)

Gynecological (Standard Number of Subjects = 30)

Pediatric (Standard Number of Subjects = 30) (Note: IRB required for all pediatric studies)

Acne (Standard Number of Subjects = 30)

SKIN TYPE: Normal Skin

SKIN TYPE: Sensitive Skin

Custom designed Safety-in-Use. Someone from RCTS will contact you to discuss.

Questions or Comments

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* 9. Institutional Review Board

Optional

Required

TBD

I am interested in both IRB and non-IRB studies.

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* 10. Study Start Date, Month and Year

	Month	Year
Month and Year	Month and Year Month menu	Month and Year Year menu

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* 11. Study Start Date, Quarter and Year (If unsure about month)

	Quarter	Year
Quarter and Year	Quarter and Year Quarter menu	Quarter and Year Year menu

Question Title

* 1. Please tell us how we can contact you:

Question Title

* 2. Your company's website:

Question Title

* 3. Product Category: Please choose as many of interest to you.

Question Title

* 4. Human Repeat Insult Test (HRIPT)/Photosensitization. Check all that apply.

Question Title

* 5. Cumulative Irritation Test (CIT)

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* 6. Acute Irritation

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* 7. Comedogenicity

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* 8. Safety-In-Use Study Options: Please choose all that apply

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* 9. Institutional Review Board

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* 10. Study Start Date, Month and Year

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* 11. Study Start Date, Quarter and Year (If unsure about month)

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* 12. Do you have any other comments or questions about our skin safety study services?