Effects on the Scalp Microbiota of a 1% Selenium Disulfide and 1% Salicylic Acid Shampoo After 2% Ketaconazole Foaming Gel Treatment for Scalp Seborrheic Dermatitis
Condition: Scalp Dermatitis; Dermatitis
MeSH terms: Dermatitis; Dermatitis, Seborrheic
Study type: Interventional

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).
    

Intervention name(s): cosmetic product
Intervention type(s): Other
Intervention description(s): Disulfure de sélénium versus placebo formula
Other intervention name(s): vichy dercos
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: seborrheic dermatitis; microbiota; malassezia; bacteria; diversity