Study to Find Out if Cream V61-044 Used to Treat Fungal Infections Causes an Allergic Skin Reaction to Sunlight in Healthy Participants
Condition: Dermatitis, Photoallergic
MeSH terms: Dermatitis; Dermatitis, Photoallergic
Study type: Interventional
Phase: Phase 3

Summary: 
      Allergic skin reaction can be produced by the combination of a chemical product applied to
      the skin and ultraviolet (UV) radiation (a type of invisible light that comes from the sun
      and other light sources and can hurt your skin and eyes) received by the person. The
      researchers in this study wanted to find out if cream V61-044 might cause an allergic skin
      reaction to sunlight when applied to the skin in healthy participants. Cream V61-044 (brand
      name: LOTRIMIN ULTRA) is an approved drug used to treat infections caused by fungi (small
      growing organisms such as mold, mildew, yeast or mushrooms).

      Participants joining this study underwent two study phases: in Induction phase, participants
      received the test cream and UV radiation twice a week for 3 weeks; after 10 days of rest, in
      Challenge phase participants received the test cream and UV radiation once again. In both
      phases, the test cream was applied to two test areas on the upper back of the participants
      and to one of the test area UV radiation was applied. Evaluation on the skin rash was
      conducted two days after each UV radiation.
    


Intervention name(s): Butenafine HCl 1% (BAY1896425) - Induction Phase; Butenafine HCl 1% (BAY1896425) - Challenge Phase
Intervention type(s): Drug; Drug
Intervention description(s): To each of two test sites, approximately 20 μl/cm^2 of the Butenafine HCl 1% was applied directly to the skin and covered with a 25 mm Hilltop chamber with a Webril pad (2 cm in diameter, within an area of approximately 3 cm^2), and tape was applied over the chamber to secure the occlusive patch to the skin. On the next day, the chambers were removed and both test sites were lightly wiped. Approximately 2 μl/cm^2 of Butenafine HCl 1% was reapplied directly to the skin and lightly spread over the treated irradiated test site. The treated non-irradiated test site did not receive a similar reapplication. Between 5 and 15 minutes after application, the treated irradiated test site was irradiated with two times the subject's Minimal Erythema Dose (MED). Evaluation of the test sites occurred two days after the irradiation. This procedure was repeated two times per week for three consecutive weeks for a total of 6 induction exposures per test site.; 5 μl/cm^2 of the Butenafine HCl 1% was applied directly to each of the two virgin sites (treated sites) adjacent to the induction patch sites and covered with Hilltop chambers with Webril pad and tape was applied over the chambers to secure the occlusive patches to the skin. Two additional sites with no Butenafine HCl 1% (untreated sites) were also occluded. Sites were at least 2.5 cm apart. The patches were removed 24 hours later and the sites were lightly wiped. Test sites were evaluated. Butenafine HCl 1% (2 μl/cm^2) was applied to the treated irradiated site. After 15 minutes, the treated irradiated site and the untreated irradiated site were irradiated with 0.5 MED of UVA/UVB irradiation followed by 10 Joules/cm^2 of UVA from a xenon arc solar simulator equipped with a Schott WG345 to eliminate UVB radiation. The remaining sites served as the treated non-irradiated site and untreated non-irradiated site.
Other intervention name(s): Antifungal Cream V61-044 containing Trolamine; Antifungal Cream V61-044 containing Trolamine
Intervention MeSH terms: Antifungal Agents; Clotrimazole; Miconazole; Butenafine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment