Efficacy and Safety of CIP-Isotretinoin in Patients With Severe Recalcitrant Nodular Acne

PHASE3CompletedINTERVENTIONAL
Enrollment

925

Participants

Timeline

Start Date

September 30, 2009

Primary Completion Date

May 31, 2011

Study Completion Date

May 31, 2011

Conditions
Severe Nodular Acne
Interventions
DRUG

CIP-Isotretinoin

0.5 mg/kg/day for 4 weeks, and 1 mg/kg/day for 16 weeks, taken orally, twice daily.

DRUG

Isotretinoin

0.5 mg/kg/day for 4 weeks, and 1 mg/kg/day for 16 weeks, taken orally, twice daily.

Trial Locations (49)

19103

Paddington Testing Company Inc., Philadelphia

29651

Radiant Research, Inc., Greer

30263

MedaPhase Inc., Newnan

30327

Peachtree Dermatology Associates, PC, Atlanta

32073

Park Avenue Dermatology, Orange Park

32174

Ameriderm Research, Ormond Beach

32204

North Florida Dermatology Associates, PA, Jacksonville

32216

Ameriderm Research, Jacksonville

35205

Total Skin & Beauty Dermatology Center, Birmingham

37215

Tennessee Clinical Research Center, Nashville

37934

Dermatology Associates of Knoxville, Knoxville

42303

Dermatology and Skin Cancer Specialists / Pediaresearch, LLC, Owensboro

44118

Haber Dermatology, Clinical Research Center, South Euclid

46168

The Indiana Clinical Trials Center, PC, Plainfield

46256

Dawes Fretzin Clinical Research, Indianapolis

46617

The South Bend Clinic, LLP, South Bend

48059

Hamzavi Dermatology, Fort Gratiot

48706

Great Lakes Research Group, Bay City

55432

Minnesota Clinical Study Center, Fridley

68144

Skin Specialists, PC, Omaha

71913

Burke Pharmaceutical Research, Hot Springs

76011

Arlington Center for Dermatology, Arlington

77056

Suzanne Bruce and Associates - The Center for Skin Research, Houston

78229

Progressive Clinical Research, San Antonio

Stephen Miller, MD, PA Dermatology, San Antonio

80220

Horizons Clinical Research Center, Denver

83687

Northwest Clinical Trials, Nampa

83704

Northwest Clinical Trials, Boise

84117

Dermatology Research Center, Salt Lake City

90045

Dermatology Research Associates, Los Angeles

92056

Dermatology Specialists, Oceanside

92117

Skin Surgery Medical Group, Inc., San Diego

94538

Center for Dermatology Clinical Research, Fremont

97210

Oregon Dermatology and Research Center, Portland

99204

Premier Clinical Research, Spokane

01830

ActivMed Practices & Research, Haverhill

08009

Comprehensive Clinical Research, Berlin

V5Z 3Y1

Derm Research @ 888 Inc., Vancouver

R3C 1R4

Dermadvances Research, Winnipeg

E1C 8X3

Durondel C.P. Inc, Moncton

A1C 2H5

Newlab Clinical Research Inc., St. John's

L4M 6L2

UltraNova Skincare, Barrie

L8N 1V6

Dermatrials Research, Hamilton

N6A 3H7

The Guenther Dermatology Research Centre, London

L3P 1A8

Lynderm Research Inc., Markham

P1B 3Z7

North Bay Dermatology Centre, North Bay

L6J 7W5

Institute of Cosmetic and Laser Surgery, Oakville

N2J 1C4

K. Papp Clinical Research, Waterloo

N8W 5L7

Windsor Clinical Research, Windsor

Sponsors
All Listed Sponsors
lead

Cipher Pharmaceuticals Inc.

INDUSTRY

NCT00975143 - Efficacy and Safety of CIP-Isotretinoin in Patients With Severe Recalcitrant Nodular Acne | Biotech Hunter | Biotech Hunter