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NCT03122353 · ClinicalTrials.gov registry record · Phase 1

BE Study of Calcipotriene Hydrate and Betamethasone Dipropionate Topical Suspension in the Treatment of Scalp Psoriasis

A Phase 1 study, sponsored by Tolmar.

Completed
Registry status
Phase 1
Development phase
699
Enrollment target

NCT03122353: Completed Phase 1 study, sponsored by Tolmar.

NCT03122353 is a Phase 1 study that has completed, run by Tolmar. The registered enrollment target is 699 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (1065% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03122353, a Phase 1 study, has completed, sponsored by Tolmar.

COMPLETED
Registry status
Phase 1
Development phase
699 participants
Enrollment target

Study Summary

This study will be conducted to evaluate the therapeutic bioequivalence of a TEST formulation of calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064% to the RLD.

Primary Outcome

To evaluate the change in clinical outcome of patients exposed to Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%, Taclonex and Vehicle for scalp psoriasis. From baseline to end of study.

Interventions

  • DRUG Placebo
  • DRUG Taclonex
  • DRUG Calcipotriene and betamethasone suspension

Trial Details

FieldValue
Enrollment Target 699 participants
Start Date 2017-04-11
Est. Completion 2017-11-15
Phase Phase 1
Tolmar

4 total trials

What the finished NCT03122353 record still lists

NCT03122353 is an interventional study that assigns participants to a tested intervention. The registered 699 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (1065% higher).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT03122353 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03122353 about?

NCT03122353 is a clinical study titled "BE Study of Calcipotriene Hydrate and Betamethasone Dipropionate Topical Suspension in the Treatment of Scalp Psoriasis". This study will be conducted to evaluate the therapeutic bioequivalence of a TEST formulation of calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064% to the RLD.

What is the current status of trial NCT03122353?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 699 participants. The study started on 2017-04-11. Estimated completion is 2017-11-15.

What interventions are being tested in trial NCT03122353?

The interventions under investigation include: Placebo (DRUG), Taclonex (DRUG), Calcipotriene and betamethasone suspension (DRUG).

Who is sponsoring clinical trial NCT03122353?

This trial is sponsored by Tolmar, which has 4 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03122353's enrollment target sits among peer trials

699 20th of 2000 higher than 1,981 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 NCT03122353, the US trial registry maintained by the National Library of Medicine. NCT03122353 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.