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NCT00669071 · ClinicalTrials.gov registry record · Phase 4
Treatment w/ Tri-Luma® Cream & Intense Pulsed Light (IPL) vs a Mild Inactive Control Cream & Intense Pulsed Light (IPL) in Melasma
A Phase 4 study, sponsored by Galderma R&D.
- Terminated
- Registry status
- Phase 4
- Development phase
- 56
- Enrollment target
NCT00669071: Clinical Trial Phase 4 study, sponsored by Galderma R&D.
NCT00669071 is a Phase 4 study that was terminated before completion, run by Galderma R&D. The registered enrollment target is 56 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00669071, a Phase 4 study, was terminated before completion, sponsored by Galderma R&D.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 56 participants
- Enrollment target
Study Summary
This study is to evaluate the efficacy and safety of Tri-Luma® Cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) when used sequentially with a series of intense pulsed light (IPL) treatments in Subjects diagnosed with moderate to severe melasma during a 10 week treatment period.
Primary Outcome
Number of participants who were a success or failure with regards to melasma severity at Week 10 as evaluated using the Investigator's Global Assessment (IGA) of melasma (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe) with Clear / Almost Clear being success and all others being failure
Interventions
- DRUG Fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%
- DRUG Cetaphil® Moisturizing Cream as Inactive Control
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2008-01 |
| Est. Completion | 2008-10 |
| Phase | Phase 4 |
Why NCT00669071 stopped before completion
NCT00669071 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% is the first listed.
NCT00669071 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00669071 about?
NCT00669071 is a clinical study titled "Treatment w/ Tri-Luma® Cream & Intense Pulsed Light (IPL) vs a Mild Inactive Control Cream & Intense Pulsed Light (IPL) in Melasma". This study is to evaluate the efficacy and safety of Tri-Luma® Cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) when used sequentially with a series of intense pulsed light (IPL) treatments in Subjects diagnosed with moderate to severe melasma during a 10 week treatment period.
What is the current status of trial NCT00669071?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 56 participants. The study started on 2008-01. Estimated completion is 2008-10.
What interventions are being tested in trial NCT00669071?
The interventions under investigation include: Fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% (DRUG), Cetaphil® Moisturizing Cream as Inactive Control (DRUG).
Who is sponsoring clinical trial NCT00669071?
This trial is sponsored by Galderma R&D, which has 158 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00669071's enrollment target sits among peer trials
56 1213th of 2000 higher than 783 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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