MelasmaPhase 4NCT00669071
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 testing Fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% in people with Melasma, run by Galderma R&D at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Melasma
- What is being tested?
- Fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2008to Oct 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects diagnosed with moderate to severe melasma on both sides of the face (Investigator's Global Assessment (IGA) at baseline must be 3 or 4.)
Who cannot join
- Subjects with a diagnosis of skin cancer (Basal Cell Carcinoma (BCC), Squamous Cell Carcinoma (SCC), Melanoma) in the areas to be treated
- Subjects with prior facial Intense Pulsed Light (IPL), resurfacing, deep or chemical peels within 6 months of the date of study entry
- Subject has initiated treatment with hormones including estrogen, progesterone and/or oral contraceptives within 3 months of study entry, or who intend to discontinue hormonal therapy during the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dermatology/Cosmetic Laser Associates of La Jolla, Inc.
La Jolla, California, 92037
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
About this study
Official title: Split-Face, Randomized, Open-Label Study of Sequential Treatment With Tri-Luma® Cream With Intense Pulsed Light (IPL) vs. a Mild Inactive Control Cream With Intense Pulsed Light (IPL) in Subjects With 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.
Read the detailed description
Same as above.
- Conditions
- Melasma
- Being tested
- Fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%, Cetaphil® Moisturizing Cream as Inactive Control
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%Drug
Also called Tri-Luma® Cream
Applied once daily at bedtime on one side of the face; this was a randomized, split face study where one cream was used on the right side of the face and the other cream on the left side of the face and IPL (Intense Pulsed Light) was used on both sides of the face.
Cetaphil® Moisturizing Cream as Inactive ControlDrug
Also called Cetaphil® Moisturizing Cream
Applied once daily at bedtime on the opposite side of the face; this was a randomized, split face study where one cream was used on the right side of the face and the other cream on the left side of the face and IPL (Intense Pulsed Light) was used on both sides of the face.
| Study group | Role | What they receive |
|---|---|---|
| IPL / Tri-Luma® Cream | Active comparator | Not described Receives: Drug: Fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% |
| IPL/Cetaphil® Moisturizing Cream as Inactive Control | Active comparator | Not described Receives: Drug: Cetaphil® Moisturizing Cream as Inactive Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
Measured: Baseline to week 10
Secondary outcomes (7)
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
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
Measured: Baseline to week 6
Degree of Pigmentation (Melanin) Using a Mexameter at Weeks 6 and 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.
Measured: Baseline to Week 6 and Baseline to Week 10
Number of Participants Showing Success or Failure in Improvement of Melasma at Week 6 Using the Investigator's Evaluation of Improvement
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
Measured: Baseline to week 6
Number of Participants Showing Success or Failure in Improvement of Melasma at Week 10 Using the Investigator's Evaluation of Improvement
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
Measured: Baseline to week 10
Number of Participants Showing Success or Failure in Improvement of Melasma at Week 6 Using the Subject's Evaluation of Improvement
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
Measured: Baseline to week 6
Number of Participants Showing Success or Failure in Improvement of Melasma at Week 10 Using the Subject's Evaluation of Improvement
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
Measured: Baseline to week 10
Number of Participants With Tolerability Assessments Resulting in Adverse Events
Number of participants with Tolerability assessments (erythema, scaling, dryness, stinging/burning, edema, telangiectasis, darkening or melasma spots) resulting in adverse events
Measured: Baseline to week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2008 (estimated)
- Study startJan 2008
- Primary completionOct 2008
- Study completionOct 2008
Why it stopped: Enrollment closed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MelasmaStudies of the same condition, open and under way.
- More trials run by Galderma R&DThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ron W Gottschalk, MD, Study director, Galderma R&D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00669071
- Sponsor's protocol ID
- US10081
- Status last verified
- Sep 2012
- First submitted
- 24 Apr 2008
- Last updated
- 23 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Split-Face, Randomized, Open-Label Study of Sequential Treatment With Tri-Luma® Cream With Intense Pulsed Light (IPL) vs. a Mild Inactive Control Cream With Intense Pulsed Light (IPL) in Subjects With Melasma
- ClinicalTrials.gov ID
- NCT00669071
- Acronym / sponsor ID
- US10081
- Conditions
- Melasma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment closed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 29 Apr 2008 (estimated)
- Results
- Posted 11 Jan 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Same as above.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IPL / Tri-Luma® Cream | Active comparator | Drug: Fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% |
| IPL/Cetaphil® Moisturizing Cream as Inactive Control | Active comparator | Drug: Cetaphil® Moisturizing Cream as Inactive Control |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects diagnosed with moderate to severe melasma on both sides of the face (Investigator's Global Assessment (IGA) at baseline must be 3 or 4.)
Key exclusion criteria (3 listed)
- Subjects with a diagnosis of skin cancer (Basal Cell Carcinoma (BCC), Squamous Cell Carcinoma (SCC), Melanoma) in the areas to be treated
- Subjects with prior facial Intense Pulsed Light (IPL), resurfacing, deep or chemical peels within 6 months of the date of study entry
- Subject has initiated treatment with hormones including estrogen, progesterone and/or oral contraceptives within 3 months of study entry, or who intend to discontinue hormonal therapy during the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%Also: Tri-Luma® CreamApplied once daily at bedtime on one side of the face; this was a randomized, split face study where one cream was used on the right side of the face and the other cream on the left side of the face and IPL (Intense Pulsed Light) was used on both sides of the face. | Drug | IPL / Tri-Luma® Cream |
| Cetaphil® Moisturizing Cream as Inactive ControlAlso: Cetaphil® Moisturizing CreamApplied once daily at bedtime on the opposite side of the face; this was a randomized, split face study where one cream was used on the right side of the face and the other cream on the left side of the face and IPL (Intense Pulsed Light) was used on both sides of the face. | Drug | IPL/Cetaphil® Moisturizing Cream as Inactive Control |
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
Time frame: 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
7 secondary outcomes
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
Time frame: Baseline to week 6
Degree of Pigmentation (Melanin) Using a Mexameter at Weeks 6 and 10
Time frame: Baseline to Week 6 and Baseline to Week 10
Number of Participants Showing Success or Failure in Improvement of Melasma at Week 6 Using the Investigator's Evaluation of Improvement
Time frame: Baseline to week 6
Number of Participants Showing Success or Failure in Improvement of Melasma at Week 10 Using the Investigator's Evaluation of Improvement
Time frame: Baseline to week 10
Number of Participants Showing Success or Failure in Improvement of Melasma at Week 6 Using the Subject's Evaluation of Improvement
Time frame: Baseline to week 6
Number of Participants Showing Success or Failure in Improvement of Melasma at Week 10 Using the Subject's Evaluation of Improvement
Time frame: Baseline to week 10
Number of Participants With Tolerability Assessments Resulting in Adverse Events
Time frame: Baseline to week 10
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ron W Gottschalk, MD study director
Galderma R&D
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% in people with Melasma, run by Galderma R&D at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jan 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Baseline to week 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2022.