A multicentre, randomized, single‐blind comparison of topical clindamycin 1%/benzoyl peroxide 5% once‐daily gel versus clindamycin 1% twice‐daily gel in the treatment of mild to moderate acne vulgaris in Chinese patients

Xu, Jianhua; Lu, Qianjin; Huang, Jinhua; Fei, Hao; Sun, Qiuning; Fang, Hong; Gu, Jun; Dong, Xiuqin; Zheng, Jie; Luo, Dan; Li, F.Q.; Wang, Gang; Gu, Heng; Tian, Haijun; Yang, Haowen; Xi, Liyan; Li, M.; Zheng, Min; Wu, Ye; Tu, Yating; He, Yan; Zhao, Guohao; Sheng, Wanxiang; Li, J.; Hamedani, AG

doi:10.1111/jdv.13622

Cited by 8 publications

(5 citation statements)

References 13 publications

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“…Among 2461 potential studies, 206 satisfied the inclusion criteria (eFigure in the Supplement). Among included trials, 163 (79%) were for acne and 43 (21%) were for rosacea. Rosacea RCTs were more likely to include at least 1 PROM (67% [n = 29 of 43]) compared with acne RCTs…”

Section: Resultsmentioning

confidence: 99%

“… Among included trials, 163 (79%) were for acne and 43 (21%) were for rosacea. Rosacea RCTs were more likely to include at least 1 PROM (67% [n = 29 of 43]) compared with acne RCTs…”

Section: Resultsmentioning

confidence: 99%

“…Generic PROMs were included in 82 trials (40%) compared with 27 RCTs (13%) that included a dermatology-specific PROM and 28 (14%) that included a disease-specific PROM . The most used PROMs were patient global assessments and patient satisfaction questionnaires (Table 2).…”

Section: Resultsmentioning

confidence: 99%

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Use of Patient-Reported Outcomes in Acne Vulgaris and Rosacea Clinical Trials From 2011 to 2021

Miller

Tong

et al. 2022

JAMA Dermatol

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ImportanceAcne and rosacea have substantial implications for quality of life, and it is therefore important to ensure the patient’s voice is being captured in pivotal randomized clinical trials (RCTs). Although patient-reported outcome measures (PROMs) are a valuable tool to capture the patient perspective, little is known about use of PROMs in RCTs on acne and rosacea.ObjectiveTo characterize the use of PROMs in RCTs on acne and rosacea.Evidence ReviewA systematic literature search was conducted using the search terms acne vulgaris and rosacea in the following databases: MEDLINE through PubMed, Embase, Cochrane Central Register of Controlled Trials, and Cochrane Database of Systematic Reviews. A modified search hedge for RCTs from the McGill Library was applied. All phase 2, 3, and 4 RCTs published between December 31, 2011, through December 31, 2021, that evaluated the efficacy and safety of therapies for acne and rosacea vs any comparator were eligible for inclusion.FindingsA total of 2461 publications describing RCTs were identified, of which 206 RCTs met the inclusion criteria (163 trials [79%] on acne and 43 [21%] on rosacea). At least 1 PROM was used in 53% of trials (110) included; PROM use was more common in rosacea RCTs (67% [n = 29]) compared with acne RCTs (50% [n = 81]). At least 1 dermatology-specific (13% [n = 27]) or disease-specific (14% [n = 28]) PROM was included in the RCTs analyzed. Only 7% of trials (14) included a PROM as a primary outcome measure. There was no statistically significant increase in PROM inclusion over the study period (11 of 21 trials in 2011 vs 5 of 12 trials in 2021).Conclusions and RelevanceIn this systematic review, PROMs were included in approximately one-half of acne and rosacea RCTs performed over the study period. In addition, PROMs were rarely used as a primary outcome measure, and inclusion of PROMs has not increased substantially over the past 10 years. Increasing use of PROMs in RCTs can ensure that the patient’s perspective is captured during the development of new treatments for acne and rosacea.

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Section: Resultsmentioning

confidence: 99%

“… Among included trials, 163 (79%) were for acne and 43 (21%) were for rosacea. Rosacea RCTs were more likely to include at least 1 PROM (67% [n = 29 of 43]) compared with acne RCTs…”

Section: Resultsmentioning

confidence: 99%

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Use of Patient-Reported Outcomes in Acne Vulgaris and Rosacea Clinical Trials From 2011 to 2021

Miller

Tong

et al. 2022

JAMA Dermatol

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“…19 Xu et al also found CDP 1%/BPO 5% to be superior to clindamycin 1% gel monotherapy in a single-blind randomized comparison trial of 1016 subjects with mild-to-moderate acne over 12 weeks. 20 More recently, a gel formulation containing CDP 1.2%/BPO 3.75% was developed. Pariser et al investigated the efficacy of once-daily CDP 1.2%/BPO 3.75% in 498 subjects with moderateto-severe acne over 12 weeks compared to vehicle.…”

Section: Bpo-clindamycin Combinationsmentioning

confidence: 99%

INDIVIDUAL ARTICLE: Update on Combined Topical Products for Treating Acne: Leaping From Dyads

Issa,

Kircik

2024

JDD

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Antibiotic resistance and treatment adherence remain significant challenges for acne treatment. Advances in topical formulations have ushered in an era of fixed combination topical therapeutics that are well-tolerated and more efficacious. In addition, their once-daily application leads to increased treatment adherence. This article discusses formulation strategies that allow for the coadministration of active drugs and reviews all commercially available fixed-combination topical acne treatments.

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“…Even though some of them are used in monotherapy, the advantage of various combinations of the above-mentioned substances in therapy has shown superior effects in many studies and is included in European guidelines [7,10,11]. What is more, many research studies indicate that agents such as topical antibiotics should not be used in monotherapy because of growing bacterial resistance and the limited action of such treatment [12,13].…”

Section: Topical Treatmentmentioning

confidence: 99%

Acne Vulgaris—Novel Treatment Options and Factors Affecting Therapy Adherence: A Narrative Review

Tobiasz

Nowicka

Szepietowski

2022

JCM

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Acne vulgaris is an extremely common skin condition, affecting a large population of adolescents, but at the same time, remaining a quite common issue in the group of adult patients. Its complex pathogenesis includes increased sebum secretion, impaired follicular keratinization, colonization of sebaceous glands with Cutibacterium acne bacteria, and the development of inflammation in pilosebaceous units. Although there are many methods of treatment available targeting the mechanisms mentioned above, a large percentage of patients remain undertreated or non-compliant with treatment. Ineffective treatment results in the formation of acne scars, which has a major impact on the well-being and quality of life of the patients. The aim of this publication was a review of available evidence on widely used and novel methods of topical and systemic treatment of acne, additionally including current literature-based analysis of factors affecting patients’ compliance. The strengths and limitations of novel substances for treating acne were discussed. We conclude that an effective acne treatment remains a challenge. A better understanding of current treatment options and factors affecting patients’ compliance could be a helpful tool in choosing a proper treatment option.

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A multicentre, randomized, single‐blind comparison of topical clindamycin 1%/benzoyl peroxide 5% once‐daily gel versus clindamycin 1% twice‐daily gel in the treatment of mild to moderate acne vulgaris in Chinese patients

Abstract: NCT01915732.

Cited by 8 publications

References 13 publications

Use of Patient-Reported Outcomes in Acne Vulgaris and Rosacea Clinical Trials From 2011 to 2021

Use of Patient-Reported Outcomes in Acne Vulgaris and Rosacea Clinical Trials From 2011 to 2021

INDIVIDUAL ARTICLE: Update on Combined Topical Products for Treating Acne: Leaping From Dyads

Acne Vulgaris—Novel Treatment Options and Factors Affecting Therapy Adherence: A Narrative Review

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