Dose-Finding Study of M516102 in the Treatment of Pruritus Associated With Atopic Dermatitis

A Randomized, Placebo-Controlled, Double-blind, Parallel Group, Multi-centre Phase II Dose-Finding Study of M516102 in the Treatment of Pruritus Associated With Atopic Dermatitis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00980629

Enrollment

Unknown

Registered

2009-09-21

Start date

2008-08-31

Completion date

2010-09-30

Last updated

2010-11-03

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

Conditions

Atopic Dermatitis

Brief summary

This study is to investigate the efficacy and safety of M516102 and to evaluate the dose response relationship of M516102 and placebo, in the treatment of pruritus associated with atopic dermatitis.

Interventions

DRUGM516102

Twice a day

DRUGplacebo

Twice a day

Study design

Allocation

RANDOMIZED

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Inclusion criteria

1. Male or female patients (aged 18-65 years) with a diagnosis of AD. 2. Female patients of child bearing potential must be using a medically acceptable form of contraception. 3. Patients who are able and willing to give signed informed consent. 4. Patients who have pruritus exceed the reference range.

Exclusion criteria

1. Patients who have a history of allergy to hydrocortisone. 2. Patients who have a history of relevant drug hypersensitivity. 3. Patients who have a history of contact dermatitis induced by a topical steroid. 4. Patients who are taking, and who are unwilling not to take, any medications or therapy prohibited by the protocol for the complete duration of the study. 5. Patients who have a history or presence of any cancer. 6. Patients who have any renal or liver insufficiency, or clinically significant cardiac, renal or hepatic disease. 7. Patients who, in the opinion of the investigator, are not deemed eligible as determined by medical history, physical examination or clinical laboratory safety tests. 8. Patients who have pruritus associated with conditions other than AD. 9. Patients who have pruritus only on the face and head. 10. Patients who, in the opinion of the investigator, have clinically relevant history or presence of any disease, or surgical history other than AD which is likely to affect the conduct of the study. 11. Patients who have used M5161(active ingredient of M516102). 12. Patients who cannot communicate reliably with the investigator. 13. Patients who are pregnant or lactating. 14. Patients who have used any IMP and/or participated in any clinical trial within 3 months.

Design outcomes

Primary

Measure	Time frame
Pruritus score	—

Countries

France, Germany, Poland, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026