A clinical trial to assess the safety and effect of heat therapy in comparison to standard intra-lesional sodium stibogluconate for cutaneous leishmaniasis
- Conditions
- cutaneous leishmaniasisSkin - Dermatological conditionsInfection - Other infectious diseases
- Registration Number
- ACTRN12614001288617
- Lead Sponsor
- niversity of Colombo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 194
Case definition - Patients with suggestive skin lesions (papules, nodules, plaques, ulcers and noduler-ulcers) who were clinically diagnosed by a consultant dermatologist and parasitologically confirmed as CL.
1.Non localized leishmaniasis ( VL, MCL, leishmanaisis recidivans, diffuse cutaneous lesihmaniasis and post kala-azar dermal leishmaniasis ).
2.Use of prior concomitant treatment for leishmaniasis including any traditional medicines.
3.Lesions close to nasal ,oral , urogenital , anal areas (mucosae) and the eyes
4.Multiple lesions
5.Any chronic or concomitant illnesses and people on pace makers and any metallic devices.
6.Pregnancy and breast feeding mothers
7.Children below 12 years of age
8.Immunocompromised states including HIV/AIDS and use of immunosuppressants like steroids
9.Alcohol abuse
10.Subjects not capable of understanding and complying with the study protocol
11.Known hypersensitivity or allergy to treatment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Treatment efficacy was measured by the percentage of patients clinically cured by 8 weeks , 10 weeks , 12 weeks and 16 weeks after initiation of treatment in both groups.<br>Cure was defined as complete re-epithelialization of the CL lesion with no evidence of papules, active inflammation or induration .<br>Partially cured if healing was 50-100%<br>Non –responders or treatment failures were those who had lesions that were less than 50% healed at the end of three months or if new lesions occur while on treatment.<br>[ 8 weeks , 10 weeks , 12 weeks and 16 weeks<br>];Recurrence[3 months after the last dose of treatment and 6 months after the last dose of treatment.]
- Secondary Outcome Measures
Name Time Method Any adverse events like secondary bacterial infections, allergy to treatment or hypersensitivity and worsening of the lesion clinically was recorded during or after treatment with either therapy .[Every fortnightly up to 12 weeks and then monthly at 4th month.]