NCT01471119

Sublingual Immunotherapy in Patients With Atopic Dermatitis

Usefulness and Safety of Sublingual Dermatophagoides Farinae Drops in Patients With Atopic Dermatitis:A Randomized,Double-blind,Placebo-controlled Study.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 239 (actual)
• Sponsor: Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

To assess the effect and safety of sublingual Dermatophagoides Farinae Drops in adult patients with atopic dermatitis and allergic sensitization to house dust mites.240 adults age 18 to 60 years with atopic dermatitis(Objective Scoring Atopic Dermatitis, Objective SCORAD from 10 to 40) are going to be enrolled in a randomized,double-blind,placebo-controlled study.Sublingual Dermatophagoides Farinae Drops or placebo is given for 9 months in addition to standard therapy.SCORAD,average anesis interval,rescue medicine and DLQI will be recorded.

Detailed description

SCORAD is composed of skin rash area,severity and subjective symptom including pruritus and sleeping quality.Skin rash area and severity score are objective SCORAD(range from 0 to 83).Subjective SCORAD range from 0 to 20 and total SCORAD range from 0 to 103.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
BIOLOGICAL	Dermatophagoides Farinae Drops Group 1	Dermatophagoides Farinae Drops Group 1 is the group with maintenance dose of 2 drops of grade 5 Dermatophagoides Farinae and 1 drop of placebo.
BIOLOGICAL	Dermatophagoides Farinae Drops Group 2	Dermatophagoides Farinae Drops Group 2 is the group with maintenance dose of one drop of grade 5 Dermatophagoides Farinae and 2 drop of placebo.
BIOLOGICAL	Dermatophagoides Farinae Drops Group 3	Dermatophagoides Farinae Drops Group 3 is the group with maintenance dose of 3 drops of grade 4 Dermatophagoides Farinae.
BIOLOGICAL	Placebo	Placebo Group is the group with maintenance dose of 3 drops of placebo.

Timeline

• Start date: 2011-10-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2011-11-11
• Last updated: 2018-08-17

Locations

1 site across 1 country: China