A noninferiority margin for acne lesion counts

Drug Information Journal

Volumn 42, Issue 6, 2008, Pages 607-615

  Gerlinger, Christoph ^a   Städtler, Gerald ^b   Götzelmann, Ralf ^a   Graupe, Klaus ^b   Endrikat, Jan ^c  

^a BAYER PHARMA AG   (Germany)

^b Intendis GmbH   (Germany)

^c Bayer Inc   (Canada)

Author keywords

Acne; Active control; Choice of delta; Noniferiority margin

Indexed keywords

AZELAIC ACID; DIANE; DIENOGEST PLUS ETHINYLESTRADIOL; DROSPIRENONE PLUS ETHINYLESTRADIOL; ETHINYLESTRADIOL PLUS NORGESTIMATE; FINACEA; UNCLASSIFIED DRUG;

ACNE; ADULT; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; DISEASE SEVERITY; DRUG EFFICACY; FEMALE; HUMAN; INFLAMMATION; MALE; META ANALYSIS; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SELF EVALUATION; SENSITIVITY AND SPECIFICITY; STATISTICAL ANALYSIS; SYSTEMATIC REVIEW; TREATMENT RESPONSE;

EID: 57449087983     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286150804200608     Document Type: Article

References (19)

1. James WD. Clinical practice: acne. N Engl J Med. 2005;352:1463-1472.
2. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. Clinical/ medical guidance for industry acne vulgaris: developing drugs for treatment. September 2005. Available at: http://www.fda.gov/cder/ guidance/6499dft.pdf, accessed January 16, 2007.
3. ICH (2000). International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH harmonised tripartite guideline. Choice of control group and related issues in clinical trials. Recommended for adoption at step 4 of the ICH process on July 20, 2000, by the ICH steering committee.
4. Committee for Medicinal Products for Human Use. Guideline on the Choice of the Non-Inferiority Margin. London, July 27, 2005. Doc. Ref. EMEA/ CPMP/EWP/2158/99. Available at: http://www.emea.eu.int/pdfs/human/ewp/ 215899en.pdf, accessed October 31, 2005.
5. Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977;33(1):159-174.
6. SAS Institute Inc. 2004. SAS/STAT® 9.1 User's Guide. Cary, NC: SAS Institute Inc.
7. SAS Institute Inc. Available at: www.sas.com.
8. Schmitt GJ. Scale development for clinical assessment. In: Schwindt AD, Maibaich HI, eds. Cutaneous Biometrics. New York: Kluwer; 2000.
9. Loock W. Double-blind, randomized, multicenter study with SH T 470 FA in comparison with Diane®-35 in women with acne over 9 treatment cycles. Schering AG internal research report number AM80, June 18, 1998.
10. van Vloten WA, van Haselen CW, van Zuuren EJ, Gerlinger C, Heithecker R. The effect of 2 combined oral contraceptives containing either drospirenone or cyproterone acetate on acne and seborrhea. Cutis. 2002;69(4 Suppl):2-15.
11. Alosh M, Wilkin J. Assessing the relationship between investigator global evaluation and acne lesion counts. Drug Inf J. 2004;38:343-351.
12. Lucky AW, Henderson TA, Olson WH, et al. Effectiveness of norgestimate and ethinyl estradiol in treating moderate acne vulgaris. J Am Acad Dermatol. 1997;37:746-754.
13. Redmond GP, Olson WH, Lippman JS, et al. Norgestimate and ethinyl estradiol in the treatment of acne vulgaris: a randomized, placebo-controlled trial. Obstet Gynecol. 1997;89: 615-622.
14. Bongartz M. Multicenter, double-blind, randomized parallel group study on efficacy of 0.03 mg ethinylestradiol and 2 mg dienogest in comparison to triphasic ethinylestradiol and norgestimate over six cycles in patients with acne papulopustulosa. Schering AG internal clinical study report number A07062, June 21, 2002.
15. Wack C. Multicenter, double-blind, randomized parallel group study on efficacy of 0.03 mg ethinylestradiol and 3 mg drospirenone (DRSP) in comparison to triphasic ethinylestradiol and norgestimate (NGM) over six cycles in patients with mild to moderate acne papulopustulosa. Schering AG internal clinical study report number A07148, February 25, 2003, as amended.
16. Schneider A. Multicenter, double-blind, randomized parallel group study on efficacy of 0.035 mg ethinylestradiol/2 mg cyproterone acetate and of 0.035 mg ethinylestradiol/2 mg cyproterone acetate in combination with 10 mg cyproterone acetate in comparison to triphasic ethinylestradiol/ norgestimate over 6 cycles in women with acne papulopustulosa. Schering AG internal clinical study report number A18566, July 2, 2004.
17. Zimmermann D. A 12-week, randomized, double-blind multicenter study comparing the clinical efficacy and safety of azelaic acid 15% gel (SH H 655 BA) with its vehicle (SH H 655 PBA) in patients with mild to moderate acne. Berlex Inc. internal clinical study report number A09241, September 16, 2004.
18. A 12-week, randomized, double-blind multicenter study comparing the clinical efficacy and safety of azelaic acid 15% gel (SH H 655 BA) with its vehicle (SH H 655 PBA) in patients with mild to moderate acne. Berlex Inc. internal clinical study report number A09242, September 16, 2004.
19. Gaupe K. An 8-week controlled, double-blind pilot study comparing the initial clinical effect of 15% azelaic acid hydrogel SH H 655 BA with 20% azelaic acid cream (Skinoren®) during twice-daily topical treatment of patients with papulopustular facial acne. Schering AG internal clinical study report number AU36, January 15, 1999.