Topical 2% ketoconazole cream monotherapy significantly improves adult female acne: A double‐blind, randomized placebo‐controlled trial

Chottawornsak, Natcha; Chongpison, Yuda; Asawanonda, Pravit; Kumtornrut, Chanat

doi:10.1111/1346-8138.15113

Cited by 6 publications

(7 citation statements)

References 23 publications

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“…The authors reported overall success rate of 45.0% in KTZ group and only 14.3% in control group. The study reported improvement in AFAST-F scale in 42.9% KTZ group patients and in 9.5% control group patients, and improvement in AFAST-S scale was reported in 35.0% KTZ group patients and in 33.3% control group patients [11].…”

Section: Discussionmentioning

confidence: 84%

Two Percentage of Ketoconazole Cream for the Treatment of Adult Female Acne: A Placebo-Controlled Trial

Anwar¹,

Hassan²

2020

Cureus

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Introduction Our objective was to determine the efficacy of ketoconazole (KTZ) 2% cream for the treatment of mild adult female acne (AFA). Materials and methods This placebo-controlled trial was conducted in District Headquarters (DHQ) Teaching Hospital, Sahiwal, Pakistan. The study was completed in a period of January 2019-June 2020. A total of 60 females of age > 25 years having mild AFA were included. In Group I, the patients were advised to apply 2.0% KTZ cream covering the whole skin area twice daily for a period of eight weeks. In Group II (placebo group) patients, a topical cream containing propylene glycol was applied for similar period. After eight weeks, the cream was discontinued and participants were advised to use routine skincare products, and follow-up was done after two weeks. The main study outcome was reduction in the total count of acne lesions including both inflammatory and non-inflammatory lesions and overall success rate of treatment. Results Mean age was 36.2 ± 6.3 years in KTZ group versus 35.4 ± 6.5 years in control group. Mean duration of acne was 14.3 ± 7.3 years in KTZ group versus 15.1 ± 6.9 years in control group. Improvement in facial adult female acne scoring tool (AFAST) scale (AFAST-F) was observed in 13 (43.3%) patients in KTZ group and in only 4 (13.3%) patients in control group (p value = 0.009). Improvement in submandibular AFAST (AFAST-S) was observed in 12 (40.0%) patients in KTZ group and in eight (26.7%) patients in control group. The overall success rate of treatment was 14 (46.7%) in KTZ group versus 4 (13.3%) in control group (p value = 0.012). Conclusions In our study, we found significant improvement in reduction of acne lesions as well as complete recovery using 2.0% ketoconazole for the treatment of mild AFA. So KTZ can be used as a preferred treatment option for these patients.

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Section: Discussionmentioning

confidence: 84%

Two Percentage of Ketoconazole Cream for the Treatment of Adult Female Acne: A Placebo-Controlled Trial

Anwar¹,

Hassan²

2020

Cureus

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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%

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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“…In the light of emerging bacterial resistance, a randomized, double-blind, placebo-controlled study was conducted to evaluate the efficacy and safety of topical 2% ketoconazole cream. Ketoconazole cream, a topical antifungal with anti-inflammatory and antiandrogenic actions, can decrease the lipase activity of C. acnes and was shown to work against antibiotic-resistant isolates in vitro (42). The proportion of participants with acne improvement from baseline (42.9 vs. 9.5%, P=0.015) and the success rate in the ketoconazole group were significantly higher than that of the placebo group (45.0 vs. 14.3%, P=0.043).…”

Section: Treatment Of Adult Female Acnementioning

confidence: 99%

“…The proportion of participants with acne improvement from baseline (42.9 vs. 9.5%, P=0.015) and the success rate in the ketoconazole group were significantly higher than that of the placebo group (45.0 vs. 14.3%, P=0.043). Therefore, the authors concluded that ketoconazole monotherapy is a viable option for the treatment of mild adult female acne, with an excellent safety profile (42).…”

Section: Treatment Of Adult Female Acnementioning

confidence: 99%

Adult female acne: Clinical and therapeutic particularities (Review)

et al. 2021

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Acne is a chronic inflammatory condition affecting the pilosebaceous unit that was traditionally viewed as a disease of the adolescence. However, over the past several years, an increasing number of adult women have been reported to suffer from this condition. The prevalence of adult female acne ranges between 12 and 54%. Two clinical types can be distinguished in this population, a 'retentional' and an 'inflammatory' type, which usually tend to overlap. In terms of evolution, three main subtypes can be identified: Persistent acne, which is the most frequent subtype, late-onset acne and recurrent acne. This type of acne is mainly mild-to-moderate in severity and may be refractory to conventional treatment. The etiopathogenesis is complex and has yet to be fully elucidated. It appears to involve an interaction among genetic predisposition, hormonal factors, and chronic activation of the innate immune system overlapping with external factors, such as daily stress, Western-type diet, use of tobacco and cosmetics. The treatment may be challenging and a holistic approach is required, with special attention to the individual needs and particularities of adult women. Both topical and systemic treatments are available, with hormonal therapies being of special value in this population. The aim of the present article was to provide up-to-date, evidence-based information on the clinical presentation, etiopathogenesis and treatment of adult female acne. Contents1. Introduction 2. Prevalence 3. Clinical presentation 4. Etiopathogenesis 5. Treatment of adult female acne 6. Conclusions

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Topical 2% ketoconazole cream monotherapy significantly improves adult female acne: A double‐blind, randomized placebo‐controlled trial

Cited by 6 publications

References 23 publications

Two Percentage of Ketoconazole Cream for the Treatment of Adult Female Acne: A Placebo-Controlled Trial

Two Percentage of Ketoconazole Cream for the Treatment of Adult Female Acne: A Placebo-Controlled Trial

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

Adult female acne: Clinical and therapeutic particularities (Review)

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