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NCT02061813 · ClinicalTrials.gov registry record · Phase 1

Dermal Safety Study to Evaluate Potential Irritation of Abametapir Lotion

A Phase 1 study, sponsored by Dr. Reddy's Laboratories Limited.

Completed
Registry status
Phase 1
Development phase
40
Enrollment target

NCT02061813: Completed Phase 1 study, sponsored by Dr. Reddy's Laboratories Limited.

NCT02061813 is a Phase 1 study that has completed, run by Dr. Reddy's Laboratories Limited. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02061813, a Phase 1 study, has completed, sponsored by Dr. Reddy's Laboratories Limited.

COMPLETED
Registry status
Phase 1
Development phase
40 participants
Enrollment target

Study Summary

The purpose of the study is to determine the irritation potential of repeat applications of abametapir lotion on normal skin.

Primary Outcome

The evaluation of irritation is based on Modified Berger procedure and is accepted as standard methodology for assessment of cumulative irritation potential. The assessment of all patch sites for irritation symptoms will be visually assessed by a trained evaluator using the numerical equivalents (0-7) where 0 is the least irritation potential and 7 is the maximum irritation potential. The scoring will be done on daily basis from baseline through Day 21 visit. The final reported outcome is a mean

Interventions

  • DRUG Placebo
  • DRUG Saline 0.9%
  • DRUG Abametapir Lotion 0.74% w/w
  • DRUG Sodium Lauryl Sulfate

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2014-01
Est. Completion 2014-05
Phase Phase 1
Dr. Reddy's Laboratories Limited

52 total trials

What the finished NCT02061813 record still lists

NCT02061813 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).

The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.

NCT02061813 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02061813 about?

NCT02061813 is a clinical study titled "Dermal Safety Study to Evaluate Potential Irritation of Abametapir Lotion". The purpose of the study is to determine the irritation potential of repeat applications of abametapir lotion on normal skin.

What is the current status of trial NCT02061813?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2014-01. Estimated completion is 2014-05.

What interventions are being tested in trial NCT02061813?

The interventions under investigation include: Placebo (DRUG), Saline 0.9% (DRUG), Abametapir Lotion 0.74% w/w (DRUG), Sodium Lauryl Sulfate (DRUG).

Who is sponsoring clinical trial NCT02061813?

This trial is sponsored by Dr. Reddy's Laboratories Limited, which has 52 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02061813's enrollment target sits among peer trials

40 1130th of 2000 higher than 810 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02061813, the US trial registry maintained by the National Library of Medicine. NCT02061813 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.