A phase IV, open-label study evaluating the use of triple-combination therapy with minocycline HCl extended-release tablets, a topical antibiotic/retinoid preparation and benzoyl peroxide in patients with moderate to severe acne vulgaris

Andrea L. Zaenglein, Ava Shamban, Guy Webster, James Del Rosso, Jeffrey S. Dover, Leonard Swinyer, Linda Stein, Xiaoming Lin, Zoe Draelos, Michael Gold, Diane Thiboutot

Research output: Contribution to journalArticle

10 Citations (Scopus)

Abstract

Background: Moderate to severe acne vulgaris is often treated with a combination of an oral antibiotic, topical antibiotic/retinoid, and benzoyl peroxide (BP), but data are limited on the efficacy of this and other combination regimens that incorporate both oral and topical therapies. Methods: Patients were required to be aged 12-30 years with moderate to severe acne (grades 3-4 acne on the Investigator's Global Assessment [IGA]) and deemed potential candidates for treatment with isotretinoin. Enrolled patients were given triple-combination therapy, defined in this study as oral minocycline HCl extended release ?1 mg/kg QD, 6% BP foaming cloths used QD, and clindamycin phosphate 1.2%/tretinoin 0.025% gel applied QD, and were evaluated at baseline and weeks 2, 4, 8, and 12. Results: A total of 97 patients were enrolled in the study. At week 12, 89% of patients had at least a one-grade improvement from baseline IGA and 96% had at least a one-grade improvement from baseline Global Aesthetic Improvement Scale score. Mean±SD inflammatory, non-inflammatory, and total lesion counts decreased from baseline by 61.8%±38.3%, 48.8%±34.5%, and 56.5%±29.9%, respectively. The percentage of patients evaluated as candidates for isotretinoin by independent photographic review was 77% (69/90) at baseline and only 16% (14/90) at week 12. Treatment-related adverse events (AEs) occurred in eight of 97 (8%) patients. Triple-combination therapy was not associated with any serious AEs or AEs leading to discontinuation. Conclusion: Triple-combination therapy was well tolerated and substantially reduced facial acne lesion counts, with 84% of patients judged to no longer be candidates for isotretinoin therapy by study end. These data support the clinical observation that a triple-combination regimen incorporating oral minocycline (dosed by patient weight), BP foaming cloths 6% QD, and clindamycin phosphate 1.2%/tretinoin 0.025% gel QD can substantially improve moderate to severe acne vulgaris.

Original languageEnglish (US)
Pages (from-to)619-625
Number of pages7
JournalJournal of Drugs in Dermatology
Volume12
Issue number6
StatePublished - Jun 1 2013

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Benzoyl Peroxide
Minocycline
Retinoids
Acne Vulgaris
Tablets
Anti-Bacterial Agents
Isotretinoin
Therapeutics
Tretinoin
Gels
Research Personnel
Esthetics
Weights and Measures

All Science Journal Classification (ASJC) codes

  • Dermatology

Cite this

@article{72ae5449359340a5b10c9f27f6efeaaf,
title = "A phase IV, open-label study evaluating the use of triple-combination therapy with minocycline HCl extended-release tablets, a topical antibiotic/retinoid preparation and benzoyl peroxide in patients with moderate to severe acne vulgaris",
abstract = "Background: Moderate to severe acne vulgaris is often treated with a combination of an oral antibiotic, topical antibiotic/retinoid, and benzoyl peroxide (BP), but data are limited on the efficacy of this and other combination regimens that incorporate both oral and topical therapies. Methods: Patients were required to be aged 12-30 years with moderate to severe acne (grades 3-4 acne on the Investigator's Global Assessment [IGA]) and deemed potential candidates for treatment with isotretinoin. Enrolled patients were given triple-combination therapy, defined in this study as oral minocycline HCl extended release ?1 mg/kg QD, 6{\%} BP foaming cloths used QD, and clindamycin phosphate 1.2{\%}/tretinoin 0.025{\%} gel applied QD, and were evaluated at baseline and weeks 2, 4, 8, and 12. Results: A total of 97 patients were enrolled in the study. At week 12, 89{\%} of patients had at least a one-grade improvement from baseline IGA and 96{\%} had at least a one-grade improvement from baseline Global Aesthetic Improvement Scale score. Mean±SD inflammatory, non-inflammatory, and total lesion counts decreased from baseline by 61.8{\%}±38.3{\%}, 48.8{\%}±34.5{\%}, and 56.5{\%}±29.9{\%}, respectively. The percentage of patients evaluated as candidates for isotretinoin by independent photographic review was 77{\%} (69/90) at baseline and only 16{\%} (14/90) at week 12. Treatment-related adverse events (AEs) occurred in eight of 97 (8{\%}) patients. Triple-combination therapy was not associated with any serious AEs or AEs leading to discontinuation. Conclusion: Triple-combination therapy was well tolerated and substantially reduced facial acne lesion counts, with 84{\%} of patients judged to no longer be candidates for isotretinoin therapy by study end. These data support the clinical observation that a triple-combination regimen incorporating oral minocycline (dosed by patient weight), BP foaming cloths 6{\%} QD, and clindamycin phosphate 1.2{\%}/tretinoin 0.025{\%} gel QD can substantially improve moderate to severe acne vulgaris.",
author = "Zaenglein, {Andrea L.} and Ava Shamban and Guy Webster and {Del Rosso}, James and Dover, {Jeffrey S.} and Leonard Swinyer and Linda Stein and Xiaoming Lin and Zoe Draelos and Michael Gold and Diane Thiboutot",
year = "2013",
month = "6",
day = "1",
language = "English (US)",
volume = "12",
pages = "619--625",
journal = "Journal of Drugs in Dermatology",
issn = "1545-9616",
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}

A phase IV, open-label study evaluating the use of triple-combination therapy with minocycline HCl extended-release tablets, a topical antibiotic/retinoid preparation and benzoyl peroxide in patients with moderate to severe acne vulgaris. / Zaenglein, Andrea L.; Shamban, Ava; Webster, Guy; Del Rosso, James; Dover, Jeffrey S.; Swinyer, Leonard; Stein, Linda; Lin, Xiaoming; Draelos, Zoe; Gold, Michael; Thiboutot, Diane.

In: Journal of Drugs in Dermatology, Vol. 12, No. 6, 01.06.2013, p. 619-625.

Research output: Contribution to journalArticle

TY - JOUR

T1 - A phase IV, open-label study evaluating the use of triple-combination therapy with minocycline HCl extended-release tablets, a topical antibiotic/retinoid preparation and benzoyl peroxide in patients with moderate to severe acne vulgaris

AU - Zaenglein, Andrea L.

AU - Shamban, Ava

AU - Webster, Guy

AU - Del Rosso, James

AU - Dover, Jeffrey S.

AU - Swinyer, Leonard

AU - Stein, Linda

AU - Lin, Xiaoming

AU - Draelos, Zoe

AU - Gold, Michael

AU - Thiboutot, Diane

PY - 2013/6/1

Y1 - 2013/6/1

N2 - Background: Moderate to severe acne vulgaris is often treated with a combination of an oral antibiotic, topical antibiotic/retinoid, and benzoyl peroxide (BP), but data are limited on the efficacy of this and other combination regimens that incorporate both oral and topical therapies. Methods: Patients were required to be aged 12-30 years with moderate to severe acne (grades 3-4 acne on the Investigator's Global Assessment [IGA]) and deemed potential candidates for treatment with isotretinoin. Enrolled patients were given triple-combination therapy, defined in this study as oral minocycline HCl extended release ?1 mg/kg QD, 6% BP foaming cloths used QD, and clindamycin phosphate 1.2%/tretinoin 0.025% gel applied QD, and were evaluated at baseline and weeks 2, 4, 8, and 12. Results: A total of 97 patients were enrolled in the study. At week 12, 89% of patients had at least a one-grade improvement from baseline IGA and 96% had at least a one-grade improvement from baseline Global Aesthetic Improvement Scale score. Mean±SD inflammatory, non-inflammatory, and total lesion counts decreased from baseline by 61.8%±38.3%, 48.8%±34.5%, and 56.5%±29.9%, respectively. The percentage of patients evaluated as candidates for isotretinoin by independent photographic review was 77% (69/90) at baseline and only 16% (14/90) at week 12. Treatment-related adverse events (AEs) occurred in eight of 97 (8%) patients. Triple-combination therapy was not associated with any serious AEs or AEs leading to discontinuation. Conclusion: Triple-combination therapy was well tolerated and substantially reduced facial acne lesion counts, with 84% of patients judged to no longer be candidates for isotretinoin therapy by study end. These data support the clinical observation that a triple-combination regimen incorporating oral minocycline (dosed by patient weight), BP foaming cloths 6% QD, and clindamycin phosphate 1.2%/tretinoin 0.025% gel QD can substantially improve moderate to severe acne vulgaris.

AB - Background: Moderate to severe acne vulgaris is often treated with a combination of an oral antibiotic, topical antibiotic/retinoid, and benzoyl peroxide (BP), but data are limited on the efficacy of this and other combination regimens that incorporate both oral and topical therapies. Methods: Patients were required to be aged 12-30 years with moderate to severe acne (grades 3-4 acne on the Investigator's Global Assessment [IGA]) and deemed potential candidates for treatment with isotretinoin. Enrolled patients were given triple-combination therapy, defined in this study as oral minocycline HCl extended release ?1 mg/kg QD, 6% BP foaming cloths used QD, and clindamycin phosphate 1.2%/tretinoin 0.025% gel applied QD, and were evaluated at baseline and weeks 2, 4, 8, and 12. Results: A total of 97 patients were enrolled in the study. At week 12, 89% of patients had at least a one-grade improvement from baseline IGA and 96% had at least a one-grade improvement from baseline Global Aesthetic Improvement Scale score. Mean±SD inflammatory, non-inflammatory, and total lesion counts decreased from baseline by 61.8%±38.3%, 48.8%±34.5%, and 56.5%±29.9%, respectively. The percentage of patients evaluated as candidates for isotretinoin by independent photographic review was 77% (69/90) at baseline and only 16% (14/90) at week 12. Treatment-related adverse events (AEs) occurred in eight of 97 (8%) patients. Triple-combination therapy was not associated with any serious AEs or AEs leading to discontinuation. Conclusion: Triple-combination therapy was well tolerated and substantially reduced facial acne lesion counts, with 84% of patients judged to no longer be candidates for isotretinoin therapy by study end. These data support the clinical observation that a triple-combination regimen incorporating oral minocycline (dosed by patient weight), BP foaming cloths 6% QD, and clindamycin phosphate 1.2%/tretinoin 0.025% gel QD can substantially improve moderate to severe acne vulgaris.

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