Health Condition 1: null- Palmoplantar Keratoderma
Conditions
Interventions
Intervention1: Herbavate: To be applied on affected area 3 times a day for 4 weeks
Control Intervention1: Topical Salicylic Acid (6% w/w): To be applied on affected area 3 times a day for 4 weeks
Sponsors
Troikaa Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: 18 years of age or older. Clinical diagnosis of isolated (simple) palmoplantar keratoderma involving greter than or equal to 50 percent of the surface of involved acral areas. Be generally healthy as determined by brief medical history. Be capable of understanding and signing the consent form.
Exclusion criteria
Exclusion criteria: Have keratoderma associated with malignancy infection or systemic disease. Drug or toxin induced keratoderma when patient cannot avoid exposure to drug or toxin. PPK involving grater than 50 percent of the surface of involved acral areas. Have had therapy with potent topical corticosteroids within one month prior to enrollment; Have used systemic treatment with oral retinoids, corticosteroids, or with PUVA within the 8 week period prior to the beginning of the study; Are pregnant or lactating, or women not using highly effective contraception; Current participation in any other interventional clinical trial; Patients who have received treatment with any nonmarketed drug substance (i.e. an agent which has not yet been made available for clinical use) within 4 weeks prior to randomisation; Patient known or, in the opinion of the investigator, is unlikely to comply with the Clinical Study Protocol (e.g. alcoholism, drug dependency, or psychotic state).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage reduction in area of involvementTimepoint: At the end of 2 and 4 weeks of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Global assessment by patients.( PaGA)Timepoint: End of Study (After 4 weeks);Improvement in symptomsTimepoint: At the end of 2 and 4 weeks of treatment. | — |
Countries
India
Contacts
Public ContactDr Vijaya Jaiswal
Troikaa Pharmaceuticals Limited
Outcome results
None listed