Safety and Efficacy of SRD441 Ointment in Patients With Atopic Dermatitis

A Phase II, Double-Blind, Vehicle Controlled Study to Determine the Efficacy, Safety and Toleration of SRD441 Ointment in Patients With Atopic Dermatitis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00882245

Enrollment

Registered

2009-04-16

Start date

2009-04-30

Completion date

2009-10-31

Last updated

2009-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Brief summary

Atopic Dermatitis is a chronic inflammatory skin disease that affect 10 to 15% of children and 2 to 10% of adults. AD is characterised by an itchy skin eruption and may cover large parts of the body. The exact cause is unknown but is thought to be an interplay between genetic and and environmental factors. The objective of this study is to determine whether SRD441 ointment is a safe and effective therapy for mild to moderate Atopic Dermatitis.

Interventions

OTHERVehicle ointment

Topical vehicle cream

DRUGOintment

SRD441 Ointment

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male and female subjects aged 18 or over * Subjects with a history of AD * Written and dated informed consent * Satisfactory medical assessment with no clinical relevant abnormalities.

Exclusion criteria

* Subjects with current or recurrent disease (except AD) that could affect the site of application, the action, absorption or disposition of the investigational product, or clinical or laboratory assessments. * Subjects who have medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial. * Subjects with any skin tattoo, scar, cuts, bruises, or other skin damage, including excessive UV exposure, at the possible drug application sites which could impact the application of the test agent or confound the local assessments during this study. * Subjects with clinically significant renal and liver parameters, as defined as greater than 1.5 x creatinine and 3 x AST ULN (upper limit of normal) respectively.

Design outcomes

Primary

Measure	Time frame
Measure efficacy in treating acute exacerbations	4 weeks

Secondary

Measure	Time frame
Safety and local dermal tolerability	4 weeks

Countries

Bulgaria, Finland, Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026