To compare the efficacy and safety of Herbavate vs. the conventional therapy in the management of Palmoplantar Keratoderma.

Phase 4

Completed

Conditions: Health Condition 1: null- Palmoplantar Keratoderma

Registration Number: CTRI/2009/091/000756

Lead Sponsor: Troikaa Pharmaceuticals Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 150

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

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).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage reduction in area of involvementTimepoint: At the end of 2 and 4 weeks of treatment.

Secondary Outcome Measures

Name	Time	Method
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.