Funding This study was sponsored by GlaxoSmithKline K.K. (GSK Japan). Editorial support was provided by apothecom scopemedical, funded with support from Stiefel, a GSK company.

^‡

Conflicts of interest M.K. served as a coordinating investigator and a third-party reviewer of facial photographs, for which he received compensation, and has served as a consultant for other pharmaceutical companies. M.Y., H.H. and M.O. are employees of GSK, Tokyo, Japan. A.B.A.S. is a dermatologist and an employee of Stiefel, a GSK company.

^§

Plain language summary available online.

Share a link

Email
Wechat
Bluesky

Summary

Background

A topical fixed-dose clindamycin phosphate 1·2% and benzoyl peroxide 3·0% combination gel (CLNP/BPO 3%) is known to be effective and safe in white people with acne.

Objectives

To evaluate the efficacy and safety of CLNP/BPO 3·0% topically applied once or twice daily vs. CLNP twice daily in Japanese patients with acne.

Methods

Eight hundred patients were randomized to receive CLNP/BPO 3·0% once daily, CLNP/BPO 3·0% twice daily or CLNP twice daily for 12 weeks. Primary endpoints were absolute change in number of total lesions (TLs) from baseline to week 12 to demonstrate the superiority of CLNP/BPO 3·0% twice daily and noninferiority of CLNP/BPO 3·0% once daily vs. CLNP twice daily. Secondary endpoints were absolute and percentage changes in TLs, inflammatory lesions (ILs), noninflammatory lesions (non-ILs) and Investigator's Static Global Assessment (ISGA) score. Safety assessments included adverse events (AEs), laboratory tests, vital signs and local skin tolerability.

Results

Change in TL counts from baseline to week 12 for CLNP/BPO 3·0% twice daily was superior to CLNP twice daily (difference −11·0; P < 0·01); CLNP/BPO 3·0% once daily was not inferior to CLNP twice daily (difference −10·3; P < 0·01). Absolute and percentage reductions in TL, IL and non-IL counts and ISGA score were greater for CLNP/BPO 3·0% once or twice daily than for CLNP twice daily with significant differences seen from early on. Most AEs were mild or moderate. The incidence of adverse drug reactions was higher for CLNP/BPO 3·0% once (24·0%) or twice (35·1%) daily than for CLNP twice daily (9·0%).

Conclusions

Compared with CLNP twice daily, CLNP/BPO 3·0% once daily was more effective and CLNP/BPO 3·0% twice daily at least as effective, with an early onset of action and an acceptable safety and tolerability profile in Japanese patients.

Supporting Information

References

1Hayashi N, Akamatsu H, Iwatsuki K et al. [Guideline for the treatment of acne vulgaris]. Jpn J Dermatol 2008; 118: 1893–923 (in Japanese).
Google Scholar
2Gollnick H, Cunliffe W, Berson D et al. Management of acne: a report from a Global Alliance to Improve Outcomes in Acne. J Am Acad Dermatol 2003; 49(1 Suppl.): S1–37.
10.1067/mjd.2003.618
PubMed Web of Science® Google Scholar
3Kawashima M, Harada S, Loesche C, Miyachi Y. Adapalene gel 0.1% is effective and safe for Japanese patients with acne vulgaris: a randomized, multicenter, investigator-blinded, controlled study. J Dermatol Sci 2008; 49: 241–8.
10.1016/j.jdermsci.2007.09.012
CAS PubMed Web of Science® Google Scholar
4Purdy S, Deberker D. Acne vulgaris. Clin Evid (Online) 2008; 2008:pii: 1714.
PubMed Google Scholar
5Langner A, Chu A, Goulden V, Ambroziak M. A randomized, single-blind comparison of topical clindamycin + benzoyl peroxide and adapalene in the treatment of mild to moderate facial acne vulgaris. Br J Dermatol 2008; 158: 122–9.
10.1111/j.1365-2133.2007.08308.x
CAS PubMed Web of Science® Google Scholar
6Gold MH. A new, once-daily, optimized, fixed combination of clindamycin phosphate 1.2% and low-concentration benzoyl peroxide 2.5% gel for the treatment of moderate-to-severe acne. J Clin Aesthet Dermatol 2009; 2: 44–8.
Google Scholar
7 Stiefel: a GSK company. Summary product characteristics of Duac once daily 10 mg/g + 50 mg/g gel. Available at: http://www.medicines.org.uk/emc/medicine/13513/SPC/Duac+Once+Daily+10mg+g+%2b+50mg+g+Gel/ (last accessed 21 December 2014).
Google Scholar
8 Stiefel: a GSK company. Summary product characteristics of Duac once daily 10 mg/g + 30 mg/g gel. Available at: http://www.medicines.org.uk/emc/medicine/28007/SPC/Duac+Once+Daily+10+mg+g+%2b+30+mg+g+Gel/ (last accessed 21 December 2014).
Google Scholar
9Webster G, Rich P, Gold MH et al. Efficacy and tolerability of a fixed combination of clindamycin phosphate (1.2%) and low concentration benzoyl peroxide (2.5%) aqueous gel in moderate or severe acne subpopulations. J Drugs Dermatol 2009; 8: 736–43.
PubMed Web of Science® Google Scholar
10Eady AE, Cove JH, Layton AM. Is antibiotic resistance in cutaneous propionibacteria clinically relevant?: implications of resistance for acne patients and prescribers. Am J Clin Dermatol 2003; 4: 813–31.
10.2165/00128071-200304120-00002
PubMed Web of Science® Google Scholar
11Ishida N, Nakaminami H, Noguchi N et al. Antimicrobial susceptibilities of Propionibacterium acnes isolated from patients with acne vulgaris. Microbiol Immunol 2008; 52: 621–4.
10.1111/j.1348-0421.2008.00081.x
CAS PubMed Web of Science® Google Scholar
12Nakase K, Nakaminami H, Noguchi N et al. First report of high levels of clindamycin-resistant Propionibacterium acnes carrying erm(X) in Japanese patients with acne vulgaris. J Dermatol 2012; 39: 794–6.
10.1111/j.1346-8138.2011.01423.x
CAS PubMed Web of Science® Google Scholar
13Iinuma K, Noguchi N, Nakaminami H et al. Susceptibility of Propionibacterium acnes isolated from patients with acne vulgaris to zinc ascorbate and antibiotics. Clin Cosmet Investig Dermatol 2011; 4: 161–5.
CAS PubMed Google Scholar
14Thiboutot D, Gollnick H, Bettoli V et al. New insights into the management of acne: an update from the Global Alliance to Improve Outcomes in Acne group. J Am Acad Dermatol 2009; 60: S1–50.
10.1016/j.jaad.2009.01.019
PubMed Web of Science® Google Scholar
15Nast A, Dreno B, Bettoli V et al. European evidence-based (S3) guidelines for the treatment of acne. J Eur Acad Dermatol Venereol 2012; 26(Suppl. 1): S1–29.
10.1111/j.1468-3083.2011.04375.x
PubMed Google Scholar
16Pace WE. A benzoyl peroxide-sulfur cream for acne vulgaris. Can Med Assoc J 1965; 93: 252–4.
CAS PubMed Web of Science® Google Scholar
17Waller JM, Dreher F, Behnam S et al. ‘Keratolytic’ properties of benzoyl peroxide and retinoic acid resemble salicylic acid in man. Skin Pharmacol Physiol 2006; 19: 283–9.
10.1159/000093984
CAS PubMed Web of Science® Google Scholar
18Dutil M. Benzoyl peroxide: enhancing antibiotic efficacy in acne management. Skin Therapy Lett 2010; 15: 5–7.
PubMed Google Scholar
19Mills OH Jr. Kligman AM, Pochi P, Comite H. Comparing 2.5%, 5%, and 10% benzoyl peroxide on inflammatory acne vulgaris. Int J Dermatol 1986; 25: 664–7.
10.1111/j.1365-4362.1986.tb04534.x
PubMed Web of Science® Google Scholar
20Sagransky M, Yentzer BA, Feldman SR. Benzoyl peroxide: a review of its current use in the treatment of acne vulgaris. Expert Opin Pharmacother 2009; 10: 2555–62.
10.1517/14656560903277228
CAS PubMed Web of Science® Google Scholar
21Harper JC. Benzoyl peroxide development, pharmacology, formulation and clinical uses in topical fixed-combinations. J Drugs Dermatol 2010; 9: 482–7.
PubMed Web of Science® Google Scholar
22Eichenfield LF, Alio Saenz AB. Safety and efficacy of clindamycin phosphate 1.2%-benzoyl peroxide 3% fixed-dose combination gel for the treatment of acne vulgaris: a phase 3, multicenter, randomized, double-blind, active- and vehicle-controlled study. J Drugs Dermatol 2011; 10: 1382–96.
CAS PubMed Web of Science® Google Scholar
23Draelos ZD, Callender V, Young C, Dhawan SS. The effect of vehicle formulation on acne medication tolerability. Cutis 2008; 82: 281–4.
PubMed Web of Science® Google Scholar
24Jones TM, Jasper S, Alio Saenz AB. Bioavailability of clindamycin from a new clindamycin phosphate 1.2%–benzoyl peroxide 3% combination gel. Clin Pharmacol Drug Develop 2013; 2: 33–47.
10.1002/cpdd.7
CAS PubMed Web of Science® Google Scholar
25Long CC, Finlay AY. The finger-tip unit – a new practical measure. Clin Exp Dermatol 1991; 16: 444–7.
10.1111/j.1365-2230.1991.tb01232.x
CAS PubMed Web of Science® Google Scholar
26 International Conference on Harmonisation. Guidance E9: statistical principles for clinical trials. Available at: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E9/Step4/E9_Guideline.pdf (last accessed 21 December 2014).
Google Scholar
27Kawashima M, Akamatsu H, Hayashi N et al. [Survey of the patients with acne at the dermatological clinics]. Clin Dermatol 2008; 62: 673–82 (in Japanese).
Google Scholar
28Ko HC, Song M, Seo SH et al. Prospective, open-label, comparative study of clindamycin 1%/benzoyl peroxide 5% gel with adapalene 0.1% gel in Asian acne patients: efficacy and tolerability. J Eur Acad Dermatol Venereol 2009; 23: 245–50.
10.1111/j.1468-3083.2008.02920.x
CAS PubMed Web of Science® Google Scholar
29Muizzuddin N, Hellemans L, Van Overloop L et al. Structural and functional differences in barrier properties of African American, Caucasian and East Asian skin. J Dermatol Sci 2010; 59: 123–8.
10.1016/j.jdermsci.2010.06.003
CAS PubMed Web of Science® Google Scholar

Citing Literature

Volume172, Issue2

February 2015

Pages 494-503

Clindamycin phosphate 1·2%–benzoyl peroxide 3·0% fixed-dose combination gel has an effective and acceptable safety and tolerability profile for the treatment of acne vulgaris in Japanese patients: a phase III, multicentre, randomised, single-blinded, active-controlled, parallel-group study^†

Summary

Background

Objectives

Methods

Results

Conclusions

Supporting Information

References

Citing Literature

References

Information

About Wiley Online Library

Help & Support

Opportunities

Connect with Wiley

Clindamycin phosphate 1·2%–benzoyl peroxide 3·0% fixed-dose combination gel has an effective and acceptable safety and tolerability profile for the treatment of acne vulgaris in Japanese patients: a phase III, multicentre, randomised, single-blinded, active-controlled, parallel-group study†

Summary

Background

Objectives

Methods

Results

Conclusions

Supporting Information

References

Citing Literature

References

Related

Information

Clindamycin phosphate 1·2%–benzoyl peroxide 3·0% fixed-dose combination gel has an effective and acceptable safety and tolerability profile for the treatment of acne vulgaris in Japanese patients: a phase III, multicentre, randomised, single-blinded, active-controlled, parallel-group study^†