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

Assessing the response of limited scleroderma to manipulation of the kynurenine pathway. A prospective study comparing topical corticosteroids vs topical corticosteroids/tranilast

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615001356550

Enrollment

Registered

2015-12-15

Start date

2015-12-01

Completion date

2017-02-27

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

This is a cross body trial to compare the safety and efficacy of topical tranilast in morphea. This agent is an established pharmaceutical with a good safety record which has been available in Japan and Korea for 20-30 yrs but has never been marketed in Australia. It has approval for the management of keloid and hypertrophic scars in these countries. There are publshed reports of efficacy in morphea. The trial involves the application of a corticosteroid cream to one involved site on the body with the application of a cream containing both corticosteroid and the trial agent at an alternate site for a period of 3 months. Monthly clinical and laboratory assessments will be performed over this time. All currently prescribed treatments will be continued during this period.

Interventions

Cross body trial of topical betamethasone valerate 0.1% vs topical betamethasone valerate 0.1% and tranilast 1% applied twice daily over a period of 3 months. Monitoring is to be done monthly via LoSCAT scores, laboratory tests and cream return. All other prescribed therapy is to be continued. The dosage of both agents is one finger tip unit (0.5g) per hand sized region (125 sqcm)

Study design

Allocation

Randomised controlled trial

Intervention model

Other

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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

Outcome results