A multicentre, randomized, placebo-controlled trial establishing the treatment effect of TDT 068, a topical formulation containing drug-free ultra-deformable phospholipid vesicles, on the primary features of erythematotelangiectatic rosacea

Journal of the European Academy of Dermatology and Venereology

Volumn 29, Issue 2, 2015, Pages 283-290

  Luger, T ^a   Peukert, N ^b   Rother, M ^c  

^a UNIVERSITY HOSPITAL MÜNSTER   (Germany)

^b Aestheso   (Germany)

^c IMR Partner GmbH   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

DERMATOLOGICAL AGENT; TDT 068; UNCLASSIFIED DRUG; PHOSPHOLIPID; PLACEBO;

ADULT; APPLICATION SITE IRRITATION; ARTICLE; CLINICAL ARTICLE; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG SAFETY; DRUG WITHDRAWAL; EMOTION; ERYTHEMA; ERYTHEMATOTELANGIECTATIC ROSACEA; FEMALE; HUMAN; MALE; MEDICAL PHOTOGRAPHY; MULTICENTER STUDY; PHOSPHOLIPID VESICLE; PRIORITY JOURNAL; PRURITUS; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; ROSACEA; TELANGIECTASIA; AGED; CLINICAL TRIAL; MIDDLE AGED; TOPICAL DRUG ADMINISTRATION; VERY ELDERLY; YOUNG ADULT;

ADMINISTRATION, TOPICAL; ADULT; AGED; AGED, 80 AND OVER; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; MIDDLE AGED; PHOSPHOLIPIDS; PLACEBOS; ROSACEA; YOUNG ADULT;

EID: 84921596049     PISSN: 09269959     EISSN: 14683083     Source Type: Journal    
DOI: 10.1111/jdv.12520     Document Type: Article

References (18)

1. Fallen RS, Gooderham M,. Rosacea: update on management and emerging therapies. Skin Therapy Lett 2012; 17: 1-4.
2. Steinhoff M, Buddenkotte J, Aubert J, et al,. Clinical, cellular, and molecular aspects in the pathophysiology of rosacea. J Investig Dermatol Symp Proc 2011; 15: 2-11.
3. Tan J, Blume-Peytavi U, Ortonne JP, et al,. An observational cross-sectional survey of rosacea: clinical associations and progression between subtypes. Br J Dermatol 2013; 169: 555-562.
4. Culp B, Scheinfeld N,. Rosacea: a review. Pharmacol Ther 2009; 34: 38-45.
5. Van Onselen J,. Rosacea: symptoms and support. Br J Nurs 2012; 21: 1252-1255.
6. van Zuuren EJ, Kramer SF, Carter BR, Graber MA, Fedorowicz Z,. Effective and evidence-based management strategies for rosacea: summary of a Cochrane systematic review. Br J Dermatol 2011; 165: 760-781.
7. Shanler SD, Ondo AL,. Successful treatment of the erythema and flushing of rosacea using a topically applied selective alpha1-adrenergic receptor agonist, oxymetazoline. Arch Dermatol 2007; 143: 1369-1371.
8. ®) in patients with onychomycosis. Br J Dermatol 2012; 166: 1360-1362.
9. Kneer W, Rother I, Rother M, Seidel E,. IDEA-033-III-01 Study Group. A multiple-dose, open-label, safety, compliance, and usage evaluation study of epicutaneously applied Diractin (ketoprofen in Transfersome) in joint/musculoskeletal pain or soft tissue inflammation. Curr Drug Saf 2009; 4: 5-10.
10. ® (IDEA-068) and the drug-free vehicle (TDT 068) all showed significant treatment effects in a randomised psoriasis plaque study. J Invest Dermatol 2013; 133 (Suppl. 1): S163. Abstract 956.
11. Wilkin J, Dahl M, Detmar M, et al,. Standard grading system for rosacea: report of the National Rosacea Society Expert Committee on the classification and staging of rosacea. J Am Acad Dermatol 2004; 50: 907-912.
12. Nicholson K, Abramova L, Chren MM, Yeung J, Chon SY, Chen SC,. A pilot quality-of-life instrument for acne rosacea. J Am Acad Dermatol 2007; 57: 213-221.
13. ® (IDEA-070) and drug-free vehicle (TDT 070) improved symptoms in patients with inflammatory skin disease. J Invest Dermatol 2013; 133 (Suppl. 1): S163. Abstract 955.
14. Bikowski J,. Rosacea therapy: current approaches and future directions. Pract Dermatol 2012; 31-32.
15. Fowler J, Jarratt M, Moore A, et al,. Once-daily topical brimonidine tartrate gel 0·5% is a novel treatment for moderate to severe facial erythema of rosacea: results of two multicentre, randomized and vehicle-controlled studies. Br J Dermatol 2012; 166: 633-641.
16. Fowler J Jr, Jackson M, Moore A, et al,. Efficacy and safety of once-daily topical brimonidine tartrate gel 0.5% for the treatment of moderate to severe facial erythema of rosacea: results of two randomized, double-blind, and vehicle-controlled pivotal studies. J Drugs Dermatol 2013; 12: 650-656.
17. Ramey JT, Bailen E, Lockey RF,. Rhinitis medicamentosa. J Investig Allergol Clin Immunol 2006; 16: 148-155.
18. Graf P,. Long-term use of oxy- and xylometazoline nasal sprays induces rebound swelling, tolerance, and nasal hyperreactivity. Rhinology 1996; 34: 9-13.