A prospective study comparing topical corticosteroids with a combination of topical corticosteroids plus the trial agent (TA) in morphea.

Phase 1

Completed

• Conditions: MORPHEA; Skin - Dermatological conditions

• Registration Number: ACTRN12615001356550
• Lead Sponsor: DR ROWLAND NOAKES

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-15
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

Adults with morphea greater than 18 yrs of age
Non pregnant
Non lactating
No significant renal, hematological or hepatic disease

Exclusion Criteria

Less than 18 yrs of age
Pregnant or lactating females
Known sensitivity to the trial agent
Significant renal, hematological or hepatic disease

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Localized Scleroderma Cutaneous Assessment Tool (LoSCAT) score[3 months after commencing therapy]

Secondary Outcome Measures

Name	Time	Method
Therapeutic safety is to be monitored via clinical review and laboratory testing[Assessment is performed at monthly intervals after commecing therapy for a period of 3 months.]