Comparison of efficacy and safety of topical glyceryl trinitrate vs oral nifedipine in idiopathic perniosis: a randomized clinical trial
Phase 2
Completed
- Conditions
- Perniosis (chilblains)Skin - Dermatological conditions
- Registration Number
- ACTRN12613001048774
- Lead Sponsor
- The University of Faisalabad
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 65
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Therapeutic efficacy assessed clinically by a consultant dermatologist at weekly follow up visits and graded as mild, moderate or marked improvement in skin lesions.<br>[Weekly follow up visits till complete clearance of skin lesions (approximately 8 weeks)]
- Secondary Outcome Measures
Name Time Method Safety. Subjective complaints of any side effects at follow up visits were noted.<br>Possible side effects for Oral Nifedipine include<br> Bloating or swelling of the face, arms, hands, lower legs, or feet<br>Cough<br>Difficult or labored breathing<br>Dizziness or light headedness<br>Palpitations<br>Headache<br>Muscle cramps<br>Rapid weight gain<br>Shortness of breath<br>Tightness in the chest<br>Tingling of the hands or feet<br>Weakness<br>Wheezing<br>Cyanosis<br>Chest congestion<br>Chest pain<br>Chills<br>Extreme fatigue<br>Fever<br>Increased sweating<br>Nausea<br>Vomiting<br>Pain or discomfort in the arms, jaw, back, or neck<br>Severe unusual tiredness or weakness<br>Sweating<br><br>Possible side effects of Topical GTN include<br>Local irritation<br>Erythema<br>Tingling sensation<br>Contact dermatitis<br>Head ache[Weekly follow up visits till complete clearance of skin lesions (approximately 8 weeks)<br>]