BPX-01 Minocycline Topical Gel Shows Promise for the Treatment of Moderate-to-severe Inflammatory Acne Vulgaris.

Autor:	Alexis A; Dr. Alexis is with Mount Sinai St. Luke's in New York, New York.; Dr. Del Rosso is with JDR Dermatology Research in Las Vegas, Nevada.; Dr. Desai is with ACRC Trials/Innovative Dermatology in Plano, Texas.; Dr. Downie is with Image Dermatology in Montclair, New Jersey.; Dr. Draelos is with Dermatology Consulting Services in High Point, North Carolina. Drs. Feser and Forconi are with International Clinical Research in Sanford, Florida.; Dr. Fowler is with DS Research in Louisville, Kentucky.; Dr. Gold is with the Tennessee Clinical Research Center in Nashville, Tennessee.; Dr. Kaufman-Janette is with the Skin Research Institute in Coral Gables, Florida.; Dr. Lain is with the Austin Institute for Clinical Research in Heatherwilde, Texas.; Dr. Lee is with Progressive Clinical Research in San Antonio, Texas.; Dr. Ling is with MedaPhase in Newnan, Georgia.; Dr. Shamban is with Medical and Cosmetic Dermatology in Santa Monica, California.; Dr. Werschler is with Premier Clinical Research in Spokane, Washington. Ms. Daniels is with BioPharmX in Menlo Park, California., Del Rosso JQ; Dr. Alexis is with Mount Sinai St. Luke's in New York, New York.; Dr. Del Rosso is with JDR Dermatology Research in Las Vegas, Nevada.; Dr. Desai is with ACRC Trials/Innovative Dermatology in Plano, Texas.; Dr. Downie is with Image Dermatology in Montclair, New Jersey.; Dr. Draelos is with Dermatology Consulting Services in High Point, North Carolina. Drs. Feser and Forconi are with International Clinical Research in Sanford, Florida.; Dr. Fowler is with DS Research in Louisville, Kentucky.; Dr. Gold is with the Tennessee Clinical Research Center in Nashville, Tennessee.; Dr. Kaufman-Janette is with the Skin Research Institute in Coral Gables, Florida.; Dr. Lain is with the Austin Institute for Clinical Research in Heatherwilde, Texas.; Dr. Lee is with Progressive Clinical Research in San Antonio, Texas.; Dr. Ling is with MedaPhase in Newnan, Georgia.; Dr. Shamban is with Medical and Cosmetic Dermatology in Santa Monica, California.; Dr. Werschler is with Premier Clinical Research in Spokane, Washington. Ms. Daniels is with BioPharmX in Menlo Park, California., Desai SR; Dr. Alexis is with Mount Sinai St. Luke's in New York, New York.; Dr. Del Rosso is with JDR Dermatology Research in Las Vegas, Nevada.; Dr. Desai is with ACRC Trials/Innovative Dermatology in Plano, Texas.; Dr. Downie is with Image Dermatology in Montclair, New Jersey.; Dr. Draelos is with Dermatology Consulting Services in High Point, North Carolina. Drs. Feser and Forconi are with International Clinical Research in Sanford, Florida.; Dr. Fowler is with DS Research in Louisville, Kentucky.; Dr. Gold is with the Tennessee Clinical Research Center in Nashville, Tennessee.; Dr. Kaufman-Janette is with the Skin Research Institute in Coral Gables, Florida.; Dr. Lain is with the Austin Institute for Clinical Research in Heatherwilde, Texas.; Dr. Lee is with Progressive Clinical Research in San Antonio, Texas.; Dr. Ling is with MedaPhase in Newnan, Georgia.; Dr. Shamban is with Medical and Cosmetic Dermatology in Santa Monica, California.; Dr. Werschler is with Premier Clinical Research in Spokane, Washington. Ms. Daniels is with BioPharmX in Menlo Park, California., Downie JB; Dr. Alexis is with Mount Sinai St. Luke's in New York, New York.; Dr. Del Rosso is with JDR Dermatology Research in Las Vegas, Nevada.; Dr. Desai is with ACRC Trials/Innovative Dermatology in Plano, Texas.; Dr. Downie is with Image Dermatology in Montclair, New Jersey.; Dr. Draelos is with Dermatology Consulting Services in High Point, North Carolina. Drs. Feser and Forconi are with International Clinical Research in Sanford, Florida.; Dr. Fowler is with DS Research in Louisville, Kentucky.; Dr. Gold is with the Tennessee Clinical Research Center in Nashville, Tennessee.; Dr. Kaufman-Janette is with the Skin Research Institute in Coral Gables, Florida.; Dr. Lain is with the Austin Institute for Clinical Research in Heatherwilde, Texas.; Dr. Lee is with Progressive Clinical Research in San Antonio, Texas.; Dr. Ling is with MedaPhase in Newnan, Georgia.; Dr. Shamban is with Medical and Cosmetic Dermatology in Santa Monica, California.; Dr. Werschler is with Premier Clinical Research in Spokane, Washington. Ms. Daniels is with BioPharmX in Menlo Park, California., Draelos ZD; Dr. Alexis is with Mount Sinai St. Luke's in New York, New York.; Dr. Del Rosso is with JDR Dermatology Research in Las Vegas, Nevada.; Dr. Desai is with ACRC Trials/Innovative Dermatology in Plano, Texas.; Dr. Downie is with Image Dermatology in Montclair, New Jersey.; Dr. Draelos is with Dermatology Consulting Services in High Point, North Carolina. Drs. Feser and Forconi are with International Clinical Research in Sanford, Florida.; Dr. Fowler is with DS Research in Louisville, Kentucky.; Dr. Gold is with the Tennessee Clinical Research Center in Nashville, Tennessee.; Dr. Kaufman-Janette is with the Skin Research Institute in Coral Gables, Florida.; Dr. Lain is with the Austin Institute for Clinical Research in Heatherwilde, Texas.; Dr. Lee is with Progressive Clinical Research in San Antonio, Texas.; Dr. Ling is with MedaPhase in Newnan, Georgia.; Dr. Shamban is with Medical and Cosmetic Dermatology in Santa Monica, California.; Dr. Werschler is with Premier Clinical Research in Spokane, Washington. Ms. Daniels is with BioPharmX in Menlo Park, California., Feser C; Dr. Alexis is with Mount Sinai St. Luke's in New York, New York.; Dr. Del Rosso is with JDR Dermatology Research in Las Vegas, Nevada.; Dr. Desai is with ACRC Trials/Innovative Dermatology in Plano, Texas.; Dr. Downie is with Image Dermatology in Montclair, New Jersey.; Dr. Draelos is with Dermatology Consulting Services in High Point, North Carolina. Drs. Feser and Forconi are with International Clinical Research in Sanford, Florida.; Dr. Fowler is with DS Research in Louisville, Kentucky.; Dr. Gold is with the Tennessee Clinical Research Center in Nashville, Tennessee.; Dr. Kaufman-Janette is with the Skin Research Institute in Coral Gables, Florida.; Dr. Lain is with the Austin Institute for Clinical Research in Heatherwilde, Texas.; Dr. Lee is with Progressive Clinical Research in San Antonio, Texas.; Dr. Ling is with MedaPhase in Newnan, Georgia.; Dr. Shamban is with Medical and Cosmetic Dermatology in Santa Monica, California.; Dr. Werschler is with Premier Clinical Research in Spokane, Washington. Ms. Daniels is with BioPharmX in Menlo Park, California., Forconi R; Dr. Alexis is with Mount Sinai St. Luke's in New York, New York.; Dr. Del Rosso is with JDR Dermatology Research in Las Vegas, Nevada.; Dr. Desai is with ACRC Trials/Innovative Dermatology in Plano, Texas.; Dr. Downie is with Image Dermatology in Montclair, New Jersey.; Dr. Draelos is with Dermatology Consulting Services in High Point, North Carolina. Drs. Feser and Forconi are with International Clinical Research in Sanford, Florida.; Dr. Fowler is with DS Research in Louisville, Kentucky.; Dr. Gold is with the Tennessee Clinical Research Center in Nashville, Tennessee.; Dr. Kaufman-Janette is with the Skin Research Institute in Coral Gables, Florida.; Dr. Lain is with the Austin Institute for Clinical Research in Heatherwilde, Texas.; Dr. Lee is with Progressive Clinical Research in San Antonio, Texas.; Dr. Ling is with MedaPhase in Newnan, Georgia.; Dr. Shamban is with Medical and Cosmetic Dermatology in Santa Monica, California.; Dr. Werschler is with Premier Clinical Research in Spokane, Washington. Ms. Daniels is with BioPharmX in Menlo Park, California., Fowler JF Jr; Dr. Alexis is with Mount Sinai St. Luke's in New York, New York.; Dr. Del Rosso is with JDR Dermatology Research in Las Vegas, Nevada.; Dr. Desai is with ACRC Trials/Innovative Dermatology in Plano, Texas.; Dr. Downie is with Image Dermatology in Montclair, New Jersey.; Dr. Draelos is with Dermatology Consulting Services in High Point, North Carolina. Drs. Feser and Forconi are with International Clinical Research in Sanford, Florida.; Dr. Fowler is with DS Research in Louisville, Kentucky.; Dr. Gold is with the Tennessee Clinical Research Center in Nashville, Tennessee.; Dr. Kaufman-Janette is with the Skin Research Institute in Coral Gables, Florida.; Dr. Lain is with the Austin Institute for Clinical Research in Heatherwilde, Texas.; Dr. Lee is with Progressive Clinical Research in San Antonio, Texas.; Dr. Ling is with MedaPhase in Newnan, Georgia.; Dr. Shamban is with Medical and Cosmetic Dermatology in Santa Monica, California.; Dr. Werschler is with Premier Clinical Research in Spokane, Washington. Ms. Daniels is with BioPharmX in Menlo Park, California., Gold M; Dr. Alexis is with Mount Sinai St. Luke's in New York, New York.; Dr. Del Rosso is with JDR Dermatology Research in Las Vegas, Nevada.; Dr. Desai is with ACRC Trials/Innovative Dermatology in Plano, Texas.; Dr. Downie is with Image Dermatology in Montclair, New Jersey.; Dr. Draelos is with Dermatology Consulting Services in High Point, North Carolina. Drs. Feser and Forconi are with International Clinical Research in Sanford, Florida.; Dr. Fowler is with DS Research in Louisville, Kentucky.; Dr. Gold is with the Tennessee Clinical Research Center in Nashville, Tennessee.; Dr. Kaufman-Janette is with the Skin Research Institute in Coral Gables, Florida.; Dr. Lain is with the Austin Institute for Clinical Research in Heatherwilde, Texas.; Dr. Lee is with Progressive Clinical Research in San Antonio, Texas.; Dr. Ling is with MedaPhase in Newnan, Georgia.; Dr. Shamban is with Medical and Cosmetic Dermatology in Santa Monica, California.; Dr. Werschler is with Premier Clinical Research in Spokane, Washington. Ms. Daniels is with BioPharmX in Menlo Park, California., Kaufman-Janette J; Dr. Alexis is with Mount Sinai St. Luke's in New York, New York.; Dr. Del Rosso is with JDR Dermatology Research in Las Vegas, Nevada.; Dr. Desai is with ACRC Trials/Innovative Dermatology in Plano, Texas.; Dr. Downie is with Image Dermatology in Montclair, New Jersey.; Dr. Draelos is with Dermatology Consulting Services in High Point, North Carolina. Drs. Feser and Forconi are with International Clinical Research in Sanford, Florida.; Dr. Fowler is with DS Research in Louisville, Kentucky.; Dr. Gold is with the Tennessee Clinical Research Center in Nashville, Tennessee.; Dr. Kaufman-Janette is with the Skin Research Institute in Coral Gables, Florida.; Dr. Lain is with the Austin Institute for Clinical Research in Heatherwilde, Texas.; Dr. Lee is with Progressive Clinical Research in San Antonio, Texas.; Dr. Ling is with MedaPhase in Newnan, Georgia.; Dr. Shamban is with Medical and Cosmetic Dermatology in Santa Monica, California.; Dr. Werschler is with Premier Clinical Research in Spokane, Washington. Ms. Daniels is with BioPharmX in Menlo Park, California., Lain E; Dr. Alexis is with Mount Sinai St. Luke's in New York, New York.; Dr. Del Rosso is with JDR Dermatology Research in Las Vegas, Nevada.; Dr. Desai is with ACRC Trials/Innovative Dermatology in Plano, Texas.; Dr. Downie is with Image Dermatology in Montclair, New Jersey.; Dr. Draelos is with Dermatology Consulting Services in High Point, North Carolina. Drs. Feser and Forconi are with International Clinical Research in Sanford, Florida.; Dr. Fowler is with DS Research in Louisville, Kentucky.; Dr. Gold is with the Tennessee Clinical Research Center in Nashville, Tennessee.; Dr. Kaufman-Janette is with the Skin Research Institute in Coral Gables, Florida.; Dr. Lain is with the Austin Institute for Clinical Research in Heatherwilde, Texas.; Dr. Lee is with Progressive Clinical Research in San Antonio, Texas.; Dr. Ling is with MedaPhase in Newnan, Georgia.; Dr. Shamban is with Medical and Cosmetic Dermatology in Santa Monica, California.; Dr. Werschler is with Premier Clinical Research in Spokane, Washington. Ms. Daniels is with BioPharmX in Menlo Park, California., Lee M; Dr. Alexis is with Mount Sinai St. Luke's in New York, New York.; Dr. Del Rosso is with JDR Dermatology Research in Las Vegas, Nevada.; Dr. Desai is with ACRC Trials/Innovative Dermatology in Plano, Texas.; Dr. Downie is with Image Dermatology in Montclair, New Jersey.; Dr. Draelos is with Dermatology Consulting Services in High Point, North Carolina. Drs. Feser and Forconi are with International Clinical Research in Sanford, Florida.; Dr. Fowler is with DS Research in Louisville, Kentucky.; Dr. Gold is with the Tennessee Clinical Research Center in Nashville, Tennessee.; Dr. Kaufman-Janette is with the Skin Research Institute in Coral Gables, Florida.; Dr. Lain is with the Austin Institute for Clinical Research in Heatherwilde, Texas.; Dr. Lee is with Progressive Clinical Research in San Antonio, Texas.; Dr. Ling is with MedaPhase in Newnan, Georgia.; Dr. Shamban is with Medical and Cosmetic Dermatology in Santa Monica, California.; Dr. Werschler is with Premier Clinical Research in Spokane, Washington. Ms. Daniels is with BioPharmX in Menlo Park, California., Ling M; Dr. Alexis is with Mount Sinai St. Luke's in New York, New York.; Dr. Del Rosso is with JDR Dermatology Research in Las Vegas, Nevada.; Dr. Desai is with ACRC Trials/Innovative Dermatology in Plano, Texas.; Dr. Downie is with Image Dermatology in Montclair, New Jersey.; Dr. Draelos is with Dermatology Consulting Services in High Point, North Carolina. Drs. Feser and Forconi are with International Clinical Research in Sanford, Florida.; Dr. Fowler is with DS Research in Louisville, Kentucky.; Dr. Gold is with the Tennessee Clinical Research Center in Nashville, Tennessee.; Dr. Kaufman-Janette is with the Skin Research Institute in Coral Gables, Florida.; Dr. Lain is with the Austin Institute for Clinical Research in Heatherwilde, Texas.; Dr. Lee is with Progressive Clinical Research in San Antonio, Texas.; Dr. Ling is with MedaPhase in Newnan, Georgia.; Dr. Shamban is with Medical and Cosmetic Dermatology in Santa Monica, California.; Dr. Werschler is with Premier Clinical Research in Spokane, Washington. Ms. Daniels is with BioPharmX in Menlo Park, California., Shamban AT; Dr. Alexis is with Mount Sinai St. Luke's in New York, New York.; Dr. Del Rosso is with JDR Dermatology Research in Las Vegas, Nevada.; Dr. Desai is with ACRC Trials/Innovative Dermatology in Plano, Texas.; Dr. Downie is with Image Dermatology in Montclair, New Jersey.; Dr. Draelos is with Dermatology Consulting Services in High Point, North Carolina. Drs. Feser and Forconi are with International Clinical Research in Sanford, Florida.; Dr. Fowler is with DS Research in Louisville, Kentucky.; Dr. Gold is with the Tennessee Clinical Research Center in Nashville, Tennessee.; Dr. Kaufman-Janette is with the Skin Research Institute in Coral Gables, Florida.; Dr. Lain is with the Austin Institute for Clinical Research in Heatherwilde, Texas.; Dr. Lee is with Progressive Clinical Research in San Antonio, Texas.; Dr. Ling is with MedaPhase in Newnan, Georgia.; Dr. Shamban is with Medical and Cosmetic Dermatology in Santa Monica, California.; Dr. Werschler is with Premier Clinical Research in Spokane, Washington. Ms. Daniels is with BioPharmX in Menlo Park, California., Werschler WP; Dr. Alexis is with Mount Sinai St. Luke's in New York, New York.; Dr. Del Rosso is with JDR Dermatology Research in Las Vegas, Nevada.; Dr. Desai is with ACRC Trials/Innovative Dermatology in Plano, Texas.; Dr. Downie is with Image Dermatology in Montclair, New Jersey.; Dr. Draelos is with Dermatology Consulting Services in High Point, North Carolina. Drs. Feser and Forconi are with International Clinical Research in Sanford, Florida.; Dr. Fowler is with DS Research in Louisville, Kentucky.; Dr. Gold is with the Tennessee Clinical Research Center in Nashville, Tennessee.; Dr. Kaufman-Janette is with the Skin Research Institute in Coral Gables, Florida.; Dr. Lain is with the Austin Institute for Clinical Research in Heatherwilde, Texas.; Dr. Lee is with Progressive Clinical Research in San Antonio, Texas.; Dr. Ling is with MedaPhase in Newnan, Georgia.; Dr. Shamban is with Medical and Cosmetic Dermatology in Santa Monica, California.; Dr. Werschler is with Premier Clinical Research in Spokane, Washington. Ms. Daniels is with BioPharmX in Menlo Park, California., Daniels A; Dr. Alexis is with Mount Sinai St. Luke's in New York, New York.; Dr. Del Rosso is with JDR Dermatology Research in Las Vegas, Nevada.; Dr. Desai is with ACRC Trials/Innovative Dermatology in Plano, Texas.; Dr. Downie is with Image Dermatology in Montclair, New Jersey.; Dr. Draelos is with Dermatology Consulting Services in High Point, North Carolina. Drs. Feser and Forconi are with International Clinical Research in Sanford, Florida.; Dr. Fowler is with DS Research in Louisville, Kentucky.; Dr. Gold is with the Tennessee Clinical Research Center in Nashville, Tennessee.; Dr. Kaufman-Janette is with the Skin Research Institute in Coral Gables, Florida.; Dr. Lain is with the Austin Institute for Clinical Research in Heatherwilde, Texas.; Dr. Lee is with Progressive Clinical Research in San Antonio, Texas.; Dr. Ling is with MedaPhase in Newnan, Georgia.; Dr. Shamban is with Medical and Cosmetic Dermatology in Santa Monica, California.; Dr. Werschler is with Premier Clinical Research in Spokane, Washington. Ms. Daniels is with BioPharmX in Menlo Park, California.
Jazyk:	angličtina
Zdroj:	The Journal of clinical and aesthetic dermatology [J Clin Aesthet Dermatol] 2018 Nov; Vol. 11 (11), pp. 25-35. Date of Electronic Publication: 2018 Nov 01.
Abstrakt:	Background and objectives: Acne vulgaris is a highly prevalent and multifactorial skin disorder that can adversely impact health-related quality of life. Factors that contribute to the pathogenesis of acne include pilosebaceous proliferation of proinflammatory Propionibacterium acnes ( P. acnes ) bacteria, presence of circulating androgens, excess sebum production, abnormal follicular keratinization, and multiple inflammatory cascades. Oral tetracyclines-especially doxycycline and minocycline-are frequently prescribed for the treatment of moderate-to-severe acne, given their anti-inflammatory properties and their effect on P. acnes reduction. Notwithstanding their established efficacy in the management of acne vulgaris, there is a desire to limit systemic exposure to antibiotics given growing concerns regarding bacterial resistance as well as the potential for serious side effects. This report describes outcomes of two randomized, vehicle-controlled trials (Phases IIa and IIb) of BPX-01, a topical minocycline gel, in the treatment of moderate-to-severe acne. Methods: In Study 1 (NCT02709096), at a single center, 33 subjects with highly fluorescing facial skin were randomized 2:1 to BPX-01 1% or vehicle control once-daily treatment for four weeks. Changes in P. acnes quantitative bacteriological cultures were assessed, as well as cutaneous tolerance to the study drug by both subjects and the investigator. In Study 2 (NCT02815332), subjects with moderate-to-severe inflammatory nonnodular acne (n=226) at 15 centers were randomized 1:1:1 to treatment with BPX-01 1%, BPX-01 2%, or vehicle control once-daily for 12 weeks. The primary endpoint was reduction in the number of inflammatory lesions; other endpoints included the number of noninflammatory lesions, Investigator's Global Assessment (IGA) of severity, and subjective ratings (investigator and subject) of acne. In both studies, cutaneous tolerability and safety were assessed, and plasma minocycline levels were tracked with a highly sensitive assay. Results: In Study 1, BPX-01 treatment reduced P. acnes colonization by 90.9 percent, which exceeded the reduction in the vehicle control group (65.53%; p =0.020). In Study 2, treatment with BPX-01 2% reduced the number of inflammatory lesions by 58.5 percent, exceeding the reduction in the vehicle control group (43.8%; p =0.0256). Trends toward an improvement preferential to BPX-01 2% were observed in the other endpoints. Across both studies, BPX-01 treatment was well-tolerated, with no photosensitivity, postinflammatory hyperpigmentation, or skin discoloration reported. A single subject (out of 259 study participants ) was identified to have detectable levels of plasma minocycline at low levels (42ng/mL) after 12 weeks of treatment but had no signs or symptoms associated with systemic administration of minocycline. Conclusion: BPX-01 appears to exhibit an effectiveness profile for reduction of inflammatory (nonnodular) acne lesions similar to that of oral minocycline formulations. However, because BPX-01 is topical and exhibits negligible systemic exposure, the likelihood of adverse events associated with oral minocycline use is much lower. These results demonstrate effectiveness of BPX-01 topical minocycline gel in reducing P. acnes colonization, suggesting that the BPX-01 2% formulation is a promising treatment for moderate-to-severe nonnodular, inflammatory acne vulgaris in both reduction of inflammatory lesions and also overall improvement in facial acne according to IGA. Competing Interests: FUNDING:This study was sponsored and funded by BioPharmX Inc. (Menlo Park, California). DISCLOSURES:All authors except Ms. Daniels are consultants of BioPharmX and were compensated fair market value for participation in this study as investigators. Ms. Daniels is an employee of BioPharmX.
Databáze:	MEDLINE
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