Topical Application of AS101 for the Treatment of Atopic Dermatitis

NCT00927212 | Terminated Phase 2

• 1 other identifier: #76 REV 00
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Atopic Dermatitis is a chronic non contagious disease that causes itchy, inflamed skin. The purpose of this study is to evaluate the safety and efficacy of topical AS101 ointment for the treatment of Atopic dermatitis.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Modified SCORAD index

  within 6 weeks treatment and 4 weeks follow up

Secondary Outcomes (1)

• Remission period

  within 4 weeks post treatment completion

Study Arms (2)

Group 1

EXPERIMENTAL

2% AS101 ointment

Drug: AS101 ointment

Group 2

EXPERIMENTAL

4% AS101 ointment

Drug: AS101 ointment

Interventions

AS101 ointment DRUG

Twice daily topical application

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed Atopic Dermatitis for at least 6 months prior to enrollment.
• Diseased Body surface area (BSA) ≤ 20%.
• Male and Female ≥ 18.
• Adequate general health.
• Signed Informed consent form by the patient or his/her legal guardian.
• Patient must be able and willing to comply with all protocol requirements.

You may not qualify if:

• Patient who is unable to provide fully informed consent.
• Pregnant of breast-feeding females.
• Concomitant dermatologic or medical condition(s) which may interfere with the patient's response evaluation.
• Evidence of an infection in the targeted zones.
• Known sensitivity to any of the drug component.
• Immunocompromised patients.
• Concomitant medications such as:
• Topical corticosteroid within 2 weeks prior to Day 1 visit;
• Systemic steroids and immunosuppressants within 1 month prior to Day 1 visit; \*Systemic anti-histamines and antibiotics within 2 weeks prior to Day 1 visit; \*Phototherapy within 4 weeks prior to Day 1 visit;
• Anticipated exaggerated exposure to sunlight during the whole treatment period and 4 weeks prior to Day 1 visit.

Sponsors & Collaborators

• BioMAS Ltd: lead

Study Sites (1)

Dermatology department, Sheba Medical Center

Ramat Gan, Israel

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Felix Pavlotsky, MD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2009
• First Posted: June 24, 2009
• Study Start: June 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: July 17, 2014

Record last verified: 2011-06

Locations

IL (1)