Document zz8ewL0r7MvoQ2DyXJ1GyyygR

~ .% CLINICAL TEST AUTHORIZATION FOR ADULT To POIDERING es STUDY TO fi| OBJECTIVE OF CLINICACLINL ICAL STUDY REASONIS FOR Assessment of whole body powdering . PAGE REQUESTING MANAGER G. LEE AND POINTISI TO BE of adults with OF 1 PROVEN BY STUDYI JOHNSON'S Baby PROJECT NUMBER CTA NO 6429.12 Powder 49" following showering PREPARATION TO BE TESTED INAME FORMULA NO STRENGTH OR CCSE ZE JONISON'S Baby Powder 499 2636.01 DATE 1/10/77 aged TEST PREPARATION PREPARATION OF APPLICABLE INCLUDE QUANTITY AND DESCRIPTION OF 22 9 oz containers from the same lot for at PREPARATION PREPARATION TO BE EMPLOYED EMPLOYED FOR CONTROL TYPE OF CONTAINER AND CONTENT CONCENTRATION least 5 months at room temperature MONTH AT 100 s{_] NONE C3 QUANTITY AND DESCRIPTION OF CONTROL PREPARATION OF APPLICABLE INCLUDE CONCENTRATION TYPE OF CONTAINER AND CONTENT CLARIFY STUDY DESIGN ENTRIES IF NECESSARY THERAPY FACTORS DOSE FREQ & CURATION (7) Uncontrolled Crossoves Randomized As SPECIAL STUDY CONSID- protocol protocol per TYPE POPULATION Inpatient (2) Inpatient NO OF Test STUDY DESIGN ([] Single Blind {_) Double Blind Crossoves Controlled PATIENTS SEX RESTRICTIONIS Mole Female As per Mixed Mixed AGE RESTRICTION RESTRICTION NO YES Limits YES Limits Outpatient Controls Subjects Prep.:20 | Outpatient POPULATION CONTRAINDICATION CONDITION HISTORY CONCOMITANT THERAPY TO BE AVOIDED AND CONDITION DISEASE AND DIAGNOSIS REC'D FOR STUDY Adults ERATIONS protocol As As per protocol protocol As per URINALYSIS URINALYSIS DETAIL HISTORY INFO PHYSICAL EXAM SPECIAL EMPHASIS AND LAB WORK - CBC SMA ETC. INDICATE FREQ { i ' MEDICAL HISTORY PHYSICAL EXAM As per protocol : LAB DATA REQ'D ; PROTOCOL FORMAT REQUIRED A COMPLETION DATE TOTAL EXP LIMIT FOA STATUS IInnd d To To IInndd Study None . Be filed Filed 1572 1573 : Restrictions ASRP S - 1 & Specific AUTHORIZATION THIS AUTHORIZATION IS SJ Supplements (CJ Supersedes ! 4303,5256 cations to Amends Previous Authorization carn be met NEW Has no effect on Previous Auth COMMENTS ~ PROPOSED LABEL FOR TEST PREPARATION JOHNSON & JOHNSON Department of Clinical Research New Brunswick N.J. PROPOSED LABEL FOR CONTROL PREPARATION JOHNSON & JOHNSON Deportment of Clinical Research New Brunswick N.J. Control # 9 9 oz Product JOHNSON'S Eaby Powder 499 For Investigational use only JOHNSON & JOFIISON Baby Products Company Medical & Regulatory Affairs 55 .. S. Route 202 Paritan M. J. 08869 C--flASIGNATURE DIRECTOR RES SIGNATURE DATE - MANAGER AFFAIRS SIGNATURE ' - ot APPROVAL DATE FORM 39-63 NEW 9/74 es DANZA MED JOHNSON & JOHNSON BRUNSWICK N.J. 1974 0146018 JNJ 000295138