Health Condition 1: L088- Other specified local infections of the skin and subcutaneous tissue
Conditions
Interventions
Intervention1: High dose vitamin D3 supplementation as an adjuvant to standard of care: Vitamin D3 sachet(60,000 IU) once daily for 7 days will be given as an adjuvant to standard of care
Control Inte
Sponsors
GCS Medical College Hospital and Research Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients of either sex and age >18 years 2.Patients having clinical lesions suggestive of dermatophytic infection. 3.Presence of fungus seen by KOH preparation of skin scrapping from the lesion. 4.Patients suffering from recalcitrant dermatophytosis (Recurrence, Relpase or Chronic infection) Recurrent dermatophytosis is defined as recurrence of lesions after 4 weeks of completion of approved systemic therapy. Relapsing dermatophytosis is defined as occurrence of lesions, after an infection-free interval of 6-8 weeks in a patient who has been cured clinically. Chronic dermatophytic infection is defined as presence of disease for more than 6 months to 1 year, with or without recurrence, in spite of being adequately treated. 5.Patient willing to give written informed consent for study.
Exclusion criteria
Exclusion criteria: 1.Patient less than 18 years age. 2.Preexisting cardiovascular, pulmonary, hepatic, hematological, gastrointestinal, endocrine, immunologic, musculoskeletal, neurological or psychiatric disease. 3.Patients wit conditions which are known to alter vitamin D and calcitum homeostasis like ranal, thyroid and parathyroid diseases . 4.Major surgical or medical illness in last 4 weeks before screening. 5.Patient already on calcium or vitamin D supplements for diseases like osteoporosis, osteomalacia, hypoparathyroidism, pseudohypoparathyroidism. 6.Patients who are known case of granulomatous diseases like sarcoidosis, TB, leprosy, systemic fungal diseases, giant cell polymyositis, berylliosis â?? because these diseases cancause endogenous vitamin D toxicity related to abnormal extrarenal synthesis of 1,25 (OH)2 vit D by activated macrophages. 7.Any concomitant medication for purpose other than dermatophytosis management at presentation or within last 4 weeks before screening. 8.Any concomitant intake of herbal, homeopathic or other alternative therapy at presentation or within last 4 weeks before screening. 9.Alcohol dependence, alcohol abuse or drug abuse within past one year. 10.Pregnant and lactating women. 11.Clinically diagnosed as dermatophytic skin infection but negative for fungus in KOH examination. 12.Dermatophytosis independently or concomitantly involving scalp (T. Capitis), nail (onychomycosis), palm (T. pedis) and sole (T. mannum). 13.Patients having skin lesions with secondary bacterial infections.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Percentage of patients achieving grade of improvement equal to 3 at the end of 6 weeks of treatment. 2. Percentage of patients achieving Physicianâ??s Global Assessment of disease activity score more than or equal to 3 at the end of 6 weeks of treatment. 3. Percentage of patients who achieved either of the above mentioned primary outcomes but then had clinical relapse at 10 weeks or 14 weeks Timepoint: 1. At the end of 6 weeks. 2. At the end of 6 weeks. 3. At the end of 10 and 12 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage of patients achieving pruritus score equal to 0 at the end of 6 weeks. 2. Change in seum levels of IgE and calcium levels post treatment 3. Percentage of patients experiencing drug related adverse events. Timepoint: 1. At the end of 6 weeks 2. At the end of study 3. At the end of study | — |
Countries
India
Contacts
Public ContactDr Drishti Rajde
GCS Medical College, Hospital and Research Centre
Outcome results
None listed