A Phase 1/2 Multicenter, Randomized, Placebo-Controlled Double-Blind, Parallel Group Study to Evaluate the Safety and Efficacy of Two Regimens of a Candidate Topical NF kappaB Decoy in the Treatment of Adults with Mild to Moderate Atopic Dermatitis

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2005
INTERVENTION: Eligible subjects will be randomized (flipping a coin) to either active treatment or placebo (placebo means the vehicle gel without the active ingredient), which will be applied per protocol either once or twice daily for a total of 4 weeks. A 2 week follow‐up period will follow the treatment period. CONDITION: Atopic dermatitis PRIMARY OUTCOME: To evaluate the safety of once‐daily (qd) and twice‐daily (bid) topical application of NF kappaB Decoy in adult patients with mild to moderate atopic dermatitis To evaluate the tolerability of once‐daily (qd) and twice‐daily (bid) topical application of NF kappaB Decoy in adult patients with mild to moderate atopic dermatitis SECONDARY OUTCOME: To maTo make a preliminary evaluation of the efficacy of qd and bid topical application of NF kappaB Decoy in adult patients with mild to moderate atopic dermatitis.ke a preliminary evaluation of the efficacy of qd and bid topical application of NF kappaB Decoy in adult patients with mild to moderate atopic dermatitis. INCLUSION CRITERIA: Subjects in good health, who: 1. Sign an informed consent; 2. Have been given a diagnosis of atopic dermatitis as defined by: Pruritus, Eczematous dermatitis (acute, subacute, chronic) involving at least current or prior flexural lesions with chronic or relapsing course, Early age of onset (prior to 10 years of age, by history), Personal or family history of atopy; 3. If receiving antihistamines, are on a stabilized dose, and expect to maintain this dose throughout the study; 4. Are females or males of reproductive potential who are compliant in using adequate birth control or are females or males not of reproductive potential.
Epistemonikos ID: 9eee73d609e5b854bc763206603263983cf8ffa8
First added on: Aug 21, 2024