Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-24 @ 5:03 PM
NCT ID:
NCT04057950
Brief Summary:
The aim of this study was to investigate the changes in the scalp bacterial and fungal microbiota in subjects afflicted with a scalp seborrheic dermatitis (SSD) during a 2% ketoconazole-based treatment followed by a maintenance phase (1% Selenium Disulfide (SeS2)/1% salicylic acid-based shampoo versus its vehicle).
Detailed Description:
Seborrheic dermatitis is a chronic, recurrent, cutaneous inflammatory condition that causes erythema and skin flaking, sometimes appearing as macules or plaques with dry white or moist oily scales. In general, this condition affects patients in good general health.
In adults, it commonly occurs in areas with high concentrations of sebaceous glands. The scalp is the most frequently affected area (80-90 percent of the cases).
These plaques are usually masked by the hair but covered by abundant dandruff, very visible on the head and even on the clothes. In the severe forms, the dandruff plaques develop into "helmets": they then cover tufts of hair and can cause them to fall.
On the scalp, the lesions may range from mild desquamation to brownish crusts affixed to the skin and hair. Some patients report pruritus, particularly if the scalp is affected. Secondary bacterial infection may occur, aggravating erythema and exudate and causing local discomfort.
Dandruff is regarded as a mild non-inflammatory form of seborrheic dermatitis. The cause of seborrheic dermatitis is not well understood, but its occurrence appears to be related to the proliferation of commensal Malassezia species.
Seborrheic dermatitis often has a substantial negative impact on quality of life and is associated with direct and indirect medical costs.
The primary goals of therapy for seborrheic dermatitis are to clear the visible signs of disease and reduce bothersome symptoms, especially pruritus. Seborrheic dermatitis of the scalp is most conveniently treated with shampoos containing antifungal agents, corticosteroids, or keratolytic agent. They have been shown to be effective in the treatment of seborrheic dermatitis, but recurrence is common and that ongoing treatment may be necessary.
For this study, the choice of the treatment against seborrheic dermatitis was set to ketoconazole, which is a common treatment that shows efficacy.
The purpose of this study is to find a way to ameliorate the quality of life of subjects with seborrheic dermatitis. This trial will evaluate the antidandruff maintenance effect of a 1% selenium sulfide/1% salicylic acid-based shampoo (cosmetic shampoo) versus its vehicle during a 8 week application duration, after the subjects were treated with a classic antifungal treatment for seborrheic dermatitis (in this study, the treatment will be a ketoconazole-based antifungal treatment for 4 weeks in adults with light to moderate seborrheic dermatitis).
Study:
NCT04057950
Study Brief:
Protocol Section:
NCT04057950