Results of a phase III, double-blind, randomized, parallel-group, non-inferiority study evaluating the safety and efficacy of isotretinoin-lidose in patients with severe recalcitrant nodular acne

Journal of Drugs in Dermatology

Volumn 13, Issue 6, 2014, Pages 665-670

  Webster, Guy F ^a   Leyden, James J ^b   Gross, Jason A ^c  

^a THOMAS JEFFERSON UNIVERSITY   (United States)

^b UNIVERSITY OF PENNSYLVANIA   (United States)

^c Cipher Pharmaceutical Inc   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

ISOTRETINOIN; ISOTRETINOIN LIDOSE; UNCLASSIFIED DRUG; DERMATOLOGICAL AGENT; GENERIC DRUG;

ABDOMINAL PAIN; ACNE; ADOLESCENT; ADULT; ARTHRALGIA; ARTICLE; BACKACHE; CHILD; CONTACT DERMATITIS; CONTROLLED STUDY; DIET SUPPLEMENTATION; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG FORMULATION; DRUG SAFETY; DRUG SCREENING; DRY EYE; DRY SKIN; EPISTAXIS; FATIGUE; FEMALE; FOLLOW UP; HEADACHE; HUMAN; LIP DISEASE; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; MULTICENTER STUDY; MUSCULOSKELETAL PAIN; PHASE 3 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; RECALCITRANT NODULAR ACNE; SCHOOL CHILD; TREATMENT OUTCOME; YOUNG ADULT; ACNE VULGARIS; CLINICAL TRIAL; COMPARATIVE STUDY; FOOD DRUG INTERACTION; PATHOLOGY; SEVERITY OF ILLNESS INDEX;

ACNE VULGARIS; ADOLESCENT; ADULT; CHILD; DERMATOLOGIC AGENTS; DOUBLE-BLIND METHOD; DRUGS, GENERIC; FEMALE; FOOD-DRUG INTERACTIONS; HUMANS; ISOTRETINOIN; MALE; MIDDLE AGED; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84903383642     PISSN: 15459616     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (12)

1. Layton AM, Knaggs H, Taylor J, Cunliffe WJ. Isotretinoin for acne vulgaris - 10 years later: a safe and successful treatment. Br J Dermatol. 1993 Sep;129(3):292-296. (Pubitemid 23284001)
2. Spitzer RL, Williams JB, Gibbon M, First MB. The structured clinical interview for DSM-III-R (SCID). I: History, rationale, and description. Arch Gen Psychiatry. 1992 Aug;49(8):624-629.
3. Kroenke K, Spitzer RL, Williams JBW. The PHQ-9. J General Int Med. 2001;16(9):606-613.
4. Posner K, Brown GK, Stanley B, et al. The Columbia-Suicide Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry 2011;168(12):1266-1277.
5. Spitzer RL, Kroenke K, Williams JB, et al A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May;22;166(10):1092-1097.
6. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). Non-inferiority Clinical Trials. March 2010.
7. Moag-Stahlberg A. The State of Family Nutrition and Physical Activity: Are We Making Progress? Chicago, IL: Academy of Nutrition and Dietetics. January 2011.
8. Rampersaud GC, Pereira MA, Girard BL, Adams J, Metzl JD. Breakfast habits, nutritional status, body weight, and academic performance in children and adolescents. J Am Diet Assoc. 2005 May;105(5):743-762.
9. Deshmukh-Taskar PR, Nicklas TA, O'Neil CE, Keast DR, Radcliffe JD, Cho S. The relationship of breakfast skipping and type of breakfast consumption with nutrient intake and weight status in children and adolescents: the National Health and Nutrition Examination Survey 1999-2006. J Am Diet Assoc. 2010 Jun;110(6):869-878.
10. Deshmukh-Taskar PR, Radcliffe JD, Liu Y, Nicklas TA. Do breakfast skipping and breakfast type affect energy intake, nutrient intake, nutrient adequacy, and diet quality in young adults? NHANES 1999-2002. J Am Coll Nutr. 2010 Aug;29(4):407-418.
11. Jones DH, King K, Miller AJ, Cunliffe WJ. A dose-response study of I3-cisretinoic acid in acne vulgaris. Br J Dermatol. 1983 Mar;108(3):333-343. (Pubitemid 13152551)
12. Strauss JS, Rapini RP, Shalita AR, et al. Isotretinoin therapy for acne: results of a multicenter dose-response study. J Am Acad Dermatol. 1984 Mar;10(3):490-496. (Pubitemid 14150139)