Trial · NCT00669071
Treatment w/ Tri-Luma® Cream & Intense Pulsed Light (IPL) vs a Mild Inactive Control Cream & Intense Pulsed Light (IPL) in Melasma
NCT00669071, Phase 4, Terminated, Galderma R&D; results first posted 2010-01-11
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Treatment w/ Tri-Luma® Cream & Intense Pulsed Light (IPL) vs a Mild Inactive Control Cream & Intense Pulsed Light (IPL) in Melasma. Trials, record NCT00669071. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00669071
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment w/ Tri-Luma® Cream & Intense Pulsed Light (IPL) vs a Mild Inactive Control Cream & Intense Pulsed Light (IPL) in Melasma
- NCT number
- NCT00669071
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 56 participants, actual
- Lead sponsor
- Galderma R&D
- Conditions
- Melasma
- Interventions
- Fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%, Cetaphil® Moisturizing Cream as Inactive Control
- First posted
- 2008-04-29
- Last updated
- 2022-08-23
- Results first posted
- 2010-01-11
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | Baseline to week 10 | 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 |
| Secondary | Number of Participants Who Were a Success or Failure With Regards to Melasma Severity at Week 6 Using the Investigator's Global Assessment (IGA) of Melasma With Clear/Almost Clear Being Success and All Others Being Failure | Baseline to week 6 | Number of participants who were a success or failure with regards to melasma severity at Week 6 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 |
| Secondary | Degree of Pigmentation (Melanin) Using a Mexameter at Weeks 6 and 10 | Baseline to Week 6 and Baseline to Week 10 | Degree of pigmentation (melanin) using a Mexameter to record units on a scale at Weeks 6 and 10; units on a scale is a number that represents the presence or absence of melanin in the skin on a scale from 0 - 999 units with 0 units representing no melanin and 999 units representing the maximum amount of melanin. |
| Secondary | Number of Participants Showing Success or Failure in Improvement of Melasma at Week 6 Using the Investigator's Evaluation of Improvement | Baseline to week 6 | Number of participants showing success or failure in improvement of melasma at Week 6 using the Investigator's evaluation of improvement (0 = Worse, 1 = No change, 2 = Improved, 3 = Much improved, 4 = Excellent Improvement) with Improved, Much improved and Excellent Improvement defined as success and Worse or No change being defined as failure |
| Secondary | Number of Participants Showing Success or Failure in Improvement of Melasma at Week 10 Using the Investigator's Evaluation of Improvement | Baseline to week 10 | Number of participants showing success or failure in improvement of melasma at Week 10 using the Investigator's evaluation of improvement (0 = Worse, 1 = No change, 2 = Improved, 3 = Much improved, 4 = Excellent Improvement) with Improved, Much improved and Excellent Improvement defined as success and Worse or No change being defined as failure |
| Secondary | Number of Participants Showing Success or Failure in Improvement of Melasma at Week 6 Using the Subject's Evaluation of Improvement | Baseline to week 6 | Number of participants showing success or failure in improvement of melasma at Week 6 using the Subject's evaluation of improvement (0 = Worse, 1 = No change, 2 = Improved, 3 = Much improved, 4 = Excellent Improvement) with Improved, Much improved and Excellent Improvement defined as success and Worse or No change being defined as failure |
| Secondary | Number of Participants Showing Success or Failure in Improvement of Melasma at Week 10 Using the Subject's Evaluation of Improvement | Baseline to week 10 | Number of participants showing success or failure in improvement of melasma at Week 10 using the Subject's evaluation of improvement (0 = Worse, 1 = No change, 2 = Improved, 3 = Much improved, 4 = Excellent Improvement) with Improved, Much improved and Excellent Improvement defined as success and Worse or No change being defined as failure |
| Secondary | Number of Participants With Tolerability Assessments Resulting in Adverse Events | Baseline to week 10 | Number of participants with Tolerability assessments (erythema, scaling, dryness, stinging/burning, edema, telangiectasis, darkening or melasma spots) resulting in adverse events |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | Baseline to week 10 | ITT (Intent to Treat), LOCF (Last Observation Carried Forward) | participants | NUMBER |
| SECONDARY | Number of Participants Who Were a Success or Failure With Regards to Melasma Severity at Week 6 Using the Investigator's Global Assessment (IGA) of Melasma With Clear/Almost Clear Being Success and All Others Being Failure | Baseline to week 6 | ITT (Intent to Treat), LOCF (Last Observation Carried Forward) | participants | NUMBER |
| SECONDARY | Degree of Pigmentation (Melanin) Using a Mexameter at Weeks 6 and 10 | Baseline to Week 6 and Baseline to Week 10 | ITT (Intent to Treat), LOCF (Last Observation Carried Forward) | units on a scale | MEAN |
| SECONDARY | Number of Participants Showing Success or Failure in Improvement of Melasma at Week 6 Using the Investigator's Evaluation of Improvement | Baseline to week 6 | ITT (Intent to Treat), LOCF (Last Observation Carried Forward) | participants | NUMBER |
| SECONDARY | Number of Participants Showing Success or Failure in Improvement of Melasma at Week 10 Using the Investigator's Evaluation of Improvement | Baseline to week 10 | ITT (Intent to Treat), LOCF (Last Observation Carried Forward) | participants | NUMBER |
| SECONDARY | Number of Participants Showing Success or Failure in Improvement of Melasma at Week 6 Using the Subject's Evaluation of Improvement | Baseline to week 6 | ITT (Intent to Treat), LOCF (Last Observation Carried Forward) | participants | NUMBER |
| SECONDARY | Number of Participants Showing Success or Failure in Improvement of Melasma at Week 10 Using the Subject's Evaluation of Improvement | Baseline to week 10 | ITT (Intent to Treat), LOCF (Last Observation Carried Forward) | participants | NUMBER |
| SECONDARY | Number of Participants With Tolerability Assessments Resulting in Adverse Events | Baseline to week 10 | Safety | participants | NUMBER |
Source ClinicalTrials.gov
Results by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 | Intense Pulsed Light (IPL) / Tri-Luma® Cream | Success | 32 | participants | |
| 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 | Intense Pulsed Light (IPL) / Inactive Control Cream | Success | 13 | participants | |
| 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 | Intense Pulsed Light (IPL) / Tri-Luma® Cream | Failure | 24 | participants | |
| 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 | Intense Pulsed Light (IPL) / Inactive Control Cream | Failure | 43 | participants | |
| 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 | Intense Pulsed Light (IPL) / Tri-Luma® Cream | Missing | 0 | participants | |
| 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 | Intense Pulsed Light (IPL) / Inactive Control Cream | Missing | 0 | participants | |
Number of Participants Who Were a Success or Failure With Regards to Melasma Severity at Week 6 Using the Investigator's Global Assessment (IGA) of Melasma With Clear/Almost Clear Being Success and All Others Being Failure | Intense Pulsed Light (IPL) / Tri-Luma® Cream | Success | 23 | participants | |
Number of Participants Who Were a Success or Failure With Regards to Melasma Severity at Week 6 Using the Investigator's Global Assessment (IGA) of Melasma With Clear/Almost Clear Being Success and All Others Being Failure | Intense Pulsed Light (IPL) / Inactive Control Cream | Success | 8 | participants | |
Number of Participants Who Were a Success or Failure With Regards to Melasma Severity at Week 6 Using the Investigator's Global Assessment (IGA) of Melasma With Clear/Almost Clear Being Success and All Others Being Failure | Intense Pulsed Light (IPL) / Tri-Luma® Cream | Failure | 33 | participants | |
Number of Participants Who Were a Success or Failure With Regards to Melasma Severity at Week 6 Using the Investigator's Global Assessment (IGA) of Melasma With Clear/Almost Clear Being Success and All Others Being Failure | Intense Pulsed Light (IPL) / Inactive Control Cream | Failure | 48 | participants |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | IPL / Tri-Luma® Cream and IPL / Inactive Control Cream | 56 | |
| Overall Study | COMPLETED | IPL / Tri-Luma® Cream and IPL / Inactive Control Cream | 52 | |
| Overall Study | NOT COMPLETED | IPL / Tri-Luma® Cream and IPL / Inactive Control Cream | 4 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IPL / Tri-Luma® Cream and IPL / Inactive Control Cream | ||
| Total, other adverse events | IPL / Tri-Luma® Cream and IPL / Inactive Control Cream | 0 | 56 |
| Total, serious adverse events | IPL / Tri-Luma® Cream and IPL / Inactive Control Cream | 0 | 56 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Intense Pulsed Light (IPL) / Tri-Luma® Cream vs Intense Pulsed Light (IPL) / Inactive Control Cream: Number of Participants With Tolerability Assessments Resulting in Adverse Events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00669071
GET https://conductscience.org/api/trials/v1/NCT00669071/results?page=2