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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00927212
Other study ID # #76 REV 00
Secondary ID
Status Terminated
Phase Phase 2
First received June 23, 2009
Last updated July 16, 2014
Start date June 2009
Est. completion date September 2010

Study information

Verified date June 2011
Source BioMAS Ltd
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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.


Description:

Atopic dermatitis (AD) is the most common chronic inflammatory skin disease, affecting 10-20% of children and 2% of adults worldwide. The mechanism of AD is still not completely understood, but the disorder appears to result from the complex interaction between immunological responses, various susceptability genes, defects in skin barrier function, host and environmental factors and infectious agents. AS101 is a non toxic potent immunomodulator that has been shown to have beneficial effects in diverse pre clinical and clinical studies. Recently, AS101 has shown efficacy and safety in the treatment of mild to moderate Psoriasis which shares with AD a related immunological mechanism along with the AS101 ability to decrease the level of interleukins known to be involved ith the pathogenesis of AD.


Recruitment information / eligibility

Status Terminated
Enrollment 5
Est. completion date September 2010
Est. primary completion date September 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
AS101 ointment
Twice daily topical application

Locations

Country Name City State
Israel Dermatology department, Sheba Medical Center Ramat-Gan

Sponsors (1)

Lead Sponsor Collaborator
BioMAS Ltd

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Modified SCORAD index within 6 weeks treatment and 4 weeks follow up No
Secondary Remission period within 4 weeks post treatment completion No
See also
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Active, not recruiting NCT05388760 - Tralokinumab Monotherapy for Children With Moderate-to-severe Atopic Dermatitis - TRAPEDS 1 (TRAlokinumab PEDiatric Trial no. 1) Phase 2
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Recruiting NCT05029895 - A Study to Evaluate Adverse Events and Change in Disease State of Oral Upadacitinib in Adolescent Participants Ages 12 to <18 Years Old Diagnosed With Atopic Dermatitis (AD)
Terminated NCT03654755 - Study to Evaluate Long-Term Safety of ASN002 in Subjects With Moderate to Severe Atopic Dermatitis Phase 2
Completed NCT04556461 - Effects of Tralokinumab Treatment of Atopic Dermatitis on Skin Barrier Function Phase 2
Recruiting NCT04818138 - BROadband vs Narrowband photoTherapy for Eczema Trial Nested in the CACTI Cohort N/A
Completed NCT03719742 - A Clinical Study to Evaluate the Safety and Efficacy of a Baby Cleanser and a Moisturizer N/A
Completed NCT05375955 - A Study to Learn About The Study Medicine (PF-07038124) In Patients With Mild To Moderate Atopic Dermatitis Or Mild To Severe Plaque Psoriasis. Phase 2
Completed NCT03441568 - In-home Use Test of the New Modified Diprobase Formulation to Assess the Safety and Tolerability in Infants and Children Under Physician's Control N/A
Recruiting NCT06366932 - Optimization of Atopic Dermatitis Treatment That Requires Second-line Systemic Therapy Through Predictive Models Phase 4
Completed NCT03304470 - A Study to Evaluate the Safety and Efficacy of ATx201 in Subjects With Moderate Atopic Dermatitis Phase 2

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