and observed AEs, SAEs, clinical laboratory results, vital signs measurements, physical examination findings, and reasons for study discontinuation, application-site reactions were the only consistent AE associated with the study product. This is consistent
with the currently approved package insert for ketoconazole foam, 2%,7 and previous studies.8-10 Most of the treatment-related
AEs that led to study discontinuation were associated with application-site pain and/or irritation, and no treatment-related SAEs were observed. Minor variations observed in the proportions
of subjects with high, normal, and low clinical laboratory values over the course of the study were not unexpected owing
to the age, concurrent medical conditions, and concomitant medications of the participants, as well as the duration of the study. Overall, no new safety signals or trends were identified
in any of the safety parameters assessed in this 12-month study. As seborrheic dermatitis is a chronic condition requiring prolonged treatment, this study provides important safety data on the long-term use of ketoconazole foam, 2%.
Although efficacy of ketoconazole foam, 2%, was not a stated end point of the study, data collected regarding target lesion erythema, scaling, pruritus, and ISGA scores throughout the duration of the study were evaluated as efficacy variables. Improvements
in lesions were evident from week 4, and although loss of subjects to follow-up limits the conclusions that can be drawn, the use of ketoconazole foam, 2%, did appear to maintain
efficacy in those who continued the study.
The completed product preference questionnaire, intended to obtain information on the cosmetic acceptability of the study-product delivery system, showed that a high number of subjects preferred the foam vehicle to other types of application for seborrheic
dermatitis, including shampoos. The delivery system of a topical agent is an important consideration for the patient and may influence treatment adherence. Dermatologic conditions
such as seborrheic dermatitis can impact quality of life; however, this impact may be lessened through adequate adherence
to treatment.11 Foam vehicles are preferred by patients over creams and ointments, particularly in hair-bearing areas, owing to their ease of application and low residue,9 and use of a foam vehicle may improve adherence in the treatment of seborrheic
dermatitis. Poor dermatology-related quality of life is also a predictor of poor adherence.11
The study had some limitations. Evaluation of severity was limited
to the target lesion only and did not include any additional flares that may have occurred during the study. Also, there was no objective measure of adherence. However, due to the long-term nature of seborrheic dermatitis treatment, study-product usage by subjects in this study would reflect real-world or better usage.
CONCLUSION
Ketoconazole foam, 2%, had a favorable safety profile when applied
topically twice daily for up to 52 weeks by subjects with seborrheic dermatitis and maintained efficacy for the duration of the study. The safety profile of ketoconazole foam, 2%, observed
during this study was consistent with that described in the currently approved package insert for the product. The majority
of subjects found ketoconazole foam, 2%, the most highly preferred delivery vehicle, which may increase treatment adherence
in patients with chronic seborrheic dermatitis.
ACKNOWLEDGMENTS
The authors thank the investigators and participants from the various centers in Study U0275-01, which included the follow-
