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A treatment for severe nodular acne: a randomized investigator‐blinded, controlled, noninferiority trial comparing fixed‐dose adapalene/benzoyl peroxide plus doxycycline vs. oral isotretinoin
Author(s) -
Tan J.,
Humphrey S.,
Vender R.,
Barankin B.,
Gooderham M.,
Kerrouche N.,
Audibert F.,
Lynde C.
Publication year - 2014
Publication title -
british journal of dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.304
H-Index - 179
eISSN - 1365-2133
pISSN - 0007-0963
DOI - 10.1111/bjd.13191
Subject(s) - medicine , adapalene , acne , benzoyl peroxide , adverse effect , randomized controlled trial , doxycycline , fixed dose combination , population , isotretinoin , papulopustular , dermatology , confidence interval , surgery , gastroenterology , chemistry , rosacea , antibiotics , organic chemistry , environmental health , microbiology and biotechnology , polymerization , biology , polymer
Summary Background Oral isotretinoin ( ISO ) is the gold standard for severe nodular acne. However, as some patients are unwilling or unable to take, or are intolerant to, ISO , other options are needed. Objectives To compare efficacy and safety of oral ISO vs. doxycycline 200 mg plus adapalene 0·1%/benzoyl peroxide 2·5% gel (D+A/ BPO ) in severe nodular acne over 20 weeks. Methods This was a multicentre, randomized, controlled, noninferiority investigator‐blinded study involving 266 subjects. Results D+A/ BPO showed a significantly earlier onset of action in reducing nodules, papules/pustules and total lesions at week 2. ISO was superior in reducing nodules (95·6% vs. 88·7%), papules/pustules (95·2% vs. 79·6%) and total lesions (92·9% vs. 78·2%; all P < 0·01) at week 20. Half as many subjects for D+A/ BPO compared with ISO had treatment‐related, medically relevant adverse events (33 events in 18·0% of subjects vs. 73 in 33·8% of subjects, respectively). D+A/ BPO was noninferior to ISO in the intent‐to‐treat population [95% confidence interval ( CI ) −2·7 to 20·8 ( P = 0·13); 63·9% vs. 54·9% of subjects, respectively] and per‐protocol population [95% CI 3·9–28·6 ( P = 0·01); 74·3% vs. 58% of subjects, respectively), based on the composite efficacy/safety end point. Conclusions D+A/ BPO showed a favourable composite efficacy/safety profile compared with ISO . This combination is an alternative to ISO in patients intolerant to, or unable or unwilling to take, oral ISO , and is an option for treatment of severe nodular acne.