NCT01731756

Brief Summary

Effects of leaf extract of Azadirachta indica in palmer arsenical keratosis: Randomized, double-blind, placebo-control trial

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 22, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

May 5, 2014

Status Verified

May 1, 2014

Enrollment Period

11 months

First QC Date

November 16, 2012

Last Update Submit

May 2, 2014

Conditions

Arsenical Keratosis

Keywords

PalmArsenicKeratosisSalicylic acidAzadirachta indicaNeem

Outcome Measures

Primary Outcomes (1)

  • Changes in palmer arsenical keratosis

    Size and number of keratotic lesions will be reduced. These will be expressed in score.

    0 week (baseline), 12 weeks (end)

Secondary Outcomes (1)

  • Changes in arsenic level in nail

    0 week (baseline), 12 weeks (end)

Study Arms (2)

Palmer arsenical keratosis (study)

EXPERIMENTAL

Leaf extract of A. indica plus salicylic acid (6%) in petroleum jelly base will be applied on palmer keratotic lesion once daily at bedtime for 12 weeks

Other: Leaf extract of A. indicaDrug: Salicylic Acid (6%)Other: Petroleum jelly

Palmer arsenical keratosis (control)

PLACEBO COMPARATOR

Salicylic acid (6%) in petroleum jelly base will be applied on palmer keratotic lesion once daily at bedtime for 12 weeks

Drug: Salicylic Acid (6%)Other: Petroleum jelly

Interventions

Leaf extract of A. indicaOTHER

Leaf extract of A. indica plus 6% salicylic acid will be applied on palmer keratotic lesion once daily at bedtime for 12 weeks.

Palmer arsenical keratosis (study)
Salicylic Acid (6%)DRUG

Salicylic acid (6%) will be applied on palmer keratotic lesion once daily on bedtime for 12 weeks.

Palmer arsenical keratosis (control)Palmer arsenical keratosis (study)
Petroleum jellyOTHER

Petroleum jelly will be applied on palmer keratotic lesion once daily at bedtime for 12 weeks.

Palmer arsenical keratosis (control)Palmer arsenical keratosis (study)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Palmer arsenical keratosis
  • Drinking arsenic contaminated water (\>50 ppb) for more than six months
  • Patient voluntarily agree to participate

You may not qualify if:

  • Pregnancy
  • Lactating mother
  • Diabetes mellitus
  • Rheumatoid arthritis
  • Systemic lupus erythematosus
  • Psoriasis
  • Bowen's disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University

Dhaka, Bangladesh

Location

MeSH Terms

Conditions

Keratosis

Interventions

Salicylic AcidPetrolatum

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenols

Study Officials

  • Mir Misbahuddin, MBBS, PhD

    Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. and Chairman

Study Record Dates

First Submitted

November 16, 2012

First Posted

November 22, 2012

Study Start

January 1, 2013

Primary Completion

December 1, 2013

Study Completion

March 1, 2014

Last Updated

May 5, 2014

Record last verified: 2014-05

Locations

BA(1)