Tags

Type your tag names separated by a space and hit enter

Tacrolimus ointment 0.03% shows efficacy and safety in pediatric and adult patients with mild to moderate atopic dermatitis.
J Am Acad Dermatol. 2005 Aug; 53(2 Suppl 2):S177-85.JA

Abstract

BACKGROUND/OBJECTIVE

Tacrolimus ointment is approved for the treatment of moderate to severe atopic dermatitis (AD). We sought to evaluate the efficacy and safety of tacrolimus ointment 0.03% compared with vehicle in the treatment of patients with mild to moderate AD.

METHODS

Two identically designed, independent, randomized, double-blind, 6-week studies--one pediatric and one adult--in patients with mild to moderate AD were conducted. Combined data from 617 patients were used in the analysis. The primary efficacy end point was percentage of patients with treatment success (defined as "clear" or "almost clear" on the Investigator's Global AD Assessment) at end of study.

RESULTS

As early as day 4, treatment success occurred in 17.7% of patients treated with tacrolimus compared with 9.8% of patients treated with vehicle (P = .003), and by study end had increased to 49.7% for tacrolimus versus 29.0% for vehicle (P < .0001). Tacrolimus was associated with significantly less application site pruritus than vehicle (29.0% vs 37.5%; P = .03). There was no difference between tacrolimus and vehicle in the incidence of application site skin burning and stinging.

CONCLUSION

Tacrolimus ointment 0.03% is effective and safe for the management of mild to moderate AD in both adult and pediatric patients, and has a rapid onset of action.

Authors+Show Affiliations

Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire 03756, USA. M.Shane.Chapman@Hitchcock.orgNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16021173

Citation

Chapman, M Shane, et al. "Tacrolimus Ointment 0.03% Shows Efficacy and Safety in Pediatric and Adult Patients With Mild to Moderate Atopic Dermatitis." Journal of the American Academy of Dermatology, vol. 53, no. 2 Suppl 2, 2005, pp. S177-85.
Chapman MS, Schachner LA, Breneman D, et al. Tacrolimus ointment 0.03% shows efficacy and safety in pediatric and adult patients with mild to moderate atopic dermatitis. J Am Acad Dermatol. 2005;53(2 Suppl 2):S177-85.
Chapman, M. S., Schachner, L. A., Breneman, D., Boguniewicz, M., Gold, M. H., Shull, T., Linowski, G. J., & Jaracz, E. (2005). Tacrolimus ointment 0.03% shows efficacy and safety in pediatric and adult patients with mild to moderate atopic dermatitis. Journal of the American Academy of Dermatology, 53(2 Suppl 2), S177-85.
Chapman MS, et al. Tacrolimus Ointment 0.03% Shows Efficacy and Safety in Pediatric and Adult Patients With Mild to Moderate Atopic Dermatitis. J Am Acad Dermatol. 2005;53(2 Suppl 2):S177-85. PubMed PMID: 16021173.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Tacrolimus ointment 0.03% shows efficacy and safety in pediatric and adult patients with mild to moderate atopic dermatitis. AU - Chapman,M Shane, AU - Schachner,Lawrence A, AU - Breneman,Debra, AU - Boguniewicz,Mark, AU - Gold,Michael H, AU - Shull,Toni, AU - Linowski,Gregory J, AU - Jaracz,Eileen, AU - ,, PY - 2005/7/16/pubmed PY - 2005/11/1/medline PY - 2005/7/16/entrez SP - S177 EP - 85 JF - Journal of the American Academy of Dermatology JO - J. Am. Acad. Dermatol. VL - 53 IS - 2 Suppl 2 N2 - BACKGROUND/OBJECTIVE: Tacrolimus ointment is approved for the treatment of moderate to severe atopic dermatitis (AD). We sought to evaluate the efficacy and safety of tacrolimus ointment 0.03% compared with vehicle in the treatment of patients with mild to moderate AD. METHODS: Two identically designed, independent, randomized, double-blind, 6-week studies--one pediatric and one adult--in patients with mild to moderate AD were conducted. Combined data from 617 patients were used in the analysis. The primary efficacy end point was percentage of patients with treatment success (defined as "clear" or "almost clear" on the Investigator's Global AD Assessment) at end of study. RESULTS: As early as day 4, treatment success occurred in 17.7% of patients treated with tacrolimus compared with 9.8% of patients treated with vehicle (P = .003), and by study end had increased to 49.7% for tacrolimus versus 29.0% for vehicle (P < .0001). Tacrolimus was associated with significantly less application site pruritus than vehicle (29.0% vs 37.5%; P = .03). There was no difference between tacrolimus and vehicle in the incidence of application site skin burning and stinging. CONCLUSION: Tacrolimus ointment 0.03% is effective and safe for the management of mild to moderate AD in both adult and pediatric patients, and has a rapid onset of action. SN - 1097-6787 UR - https://www.unboundmedicine.com/medline/citation/16021173/Tacrolimus_ointment_0_03_shows_efficacy_and_safety_in_pediatric_and_adult_patients_with_mild_to_moderate_atopic_dermatitis_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0190962205013447 DB - PRIME DP - Unbound Medicine ER -