Comparison of efficacy and safety of topical glyceryl trinitrate vs oral nifedipine in idiopathic perniosis: a randomized clinical trial

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613001048774

Enrollment

Registered

2013-09-19

Start date

2012-12-14

Completion date

2013-02-06

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

It was a parallel group, single blinded, randomized clinical trial, in a multicenter study, carried out from December 2012 to March 2013, at Dermatology departments of two tertiary care referral centers i.e. Madina Teaching hospital and DHQ hospital, Faisalabad. All patients with perniosis were screened and all eligible patients (according to inclusion and exclusion criteria), who gave written informed consent to participate in the trial were enrolled. They were randomizd into either group A (topical GTN 0.4% cream) or group B (oral nifedipine, 10-40mg/day) by concealed random allocation (sealed envelopes) according to the sequence generated by computerized random tables. They were evaluated for improvement in signs and symptoms and any side effects, weekly till complete recovery. Complete resolution of signs and symptoms was taken as the end point. Primary outcome was better efficacy and secondary outcome was side effects.

Interventions

Arm 1= Topical glyceryl trinitrate cream 0.4% To be applied twice daily, till complete resolution of lesions (approximately 1-8 weeks) At weekly follow up visits, patients were examined by a consultant Dermatologist and improvement or deterioration of skin lesions was recorded on a per forma along with subjective assessment of improvement and any complaints about side effects.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject)

Eligibility

Sex/Gender

All

Age

12 Years to 60 Years

Healthy volunteers

Inclusion criteria

patients between 12 and 60 years of age signs & symptoms typical of perniosis and involvement of acral areas

Exclusion criteria

1. Presence of any systemic disease 2. history of Raynaud’s phenomenon 3. patients currently taking any topical or systemic medication 4. pregnant or lactating female patients 5. blood pressure below 110/70 mm Hg 6. positive ANA or RA factor

Outcome results