MelasmaPhase 4NCT00469183
Assessment of Atrophogenic Potential of Triple Combination Cream for Treatment of Melasma
A Phase 4 study testing Fluocinolone acetonide .1%, hydroquinone 4%, tretinoin .05% in people with Melasma, run by Galderma R&D at 2 sites in United States.
Trial summary
Evaluate atrophogenic potential of long-term use of Tri-Luma Cream on facial Melasma through biopsy examination. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Melasma
- What is being tested?
- Fluocinolone acetonide .1%, hydroquinone 4%, tretinoin .05%
- How many people
- 70 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2006to Apr 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must have a clinical diagnosis of moderate to severe melasma
- Subjects willing to undergo biopsy four times throughout the study, two biopsies at baseline (one in a melasma involved area and one in a non-involved area). The third and fourth biopsies will be performed at 3 months and 6 months, respectively; in order to avoid variability in histopathological findings,
- Subjects must have substantial melasma involvement of the cheeks and be willing to have the same general site biopsied at the baseline, month 3 and month 6 visits.
Who cannot join
- Subjects with diagnosis of dermal melasma
- Subjects who foresee intensive UV exposure during the study (mountain sports, UV radiation, sunbathing, etc.)
- Subjects who have used retinoids, steroids, and/or skin lightening products 4 weeks prior to study entry
- Subjects who show signs of Poikiloderma of Civatte (mandibular hyperpigmentation)
- Subjects with a history of hypertrophic scarring or a history of keloids
- Subjects who are unable to avoid the use of a class 1 steroid during their participation in the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Texas Southwestern Medical Center of Dallas
Dallas, Texas, 75390
Vitiligo and Pigmentation Institute of Southern California
Los Angeles, California, 90036
About this study
Official title: An Assessment of the Atrophogenic Potential of Triple Combination Cream Using Histology Measures in the Treatment of Moderate to Severe Melasma
Evaluate atrophogenic potential of long-term use of Tri-Luma Cream on facial Melasma through biopsy examination.
Read the detailed description
Same as above.
- Conditions
- Melasma
- Being tested
- Fluocinolone acetonide .1%, hydroquinone 4%, tretinoin .05%
- 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 .1%, hydroquinone 4%, tretinoin .05%Drug
Also called TriLuma Cream
Apply topically daily for 12 weeks and continue until condition is clear or almost clear for up to 24 weeks; Maintenance phase: Apply topically twice weekly until the end of study (24 weeks) or condition relapses
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - Skin biopsy evaluation - histological assessment of skin atrophy
Measured: Baseline, 12 weeks and 24 weeks
Secondary outcomes (1)
Tolerability assessments; Incidence of adverse events; Global Assessment of Lesion Severity; MASI; Physician Global Assessment
Measured: Baseline, 12 weeks and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2007 (estimated)
- Study startMay 2006
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ronald W Gottschalk, MD, Study director, Galderma R&D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00469183
- Sponsor's protocol ID
- US10010
- Status last verified
- Mar 2008
- First submitted
- 2 May 2007
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Grimes PE, Bhawan J, Guevara IL, Colon LE, Johnson LA, Gottschalk RW, Pandya AG. Continuous therapy followed by a maintenance therapy regimen with a triple combination cream for melasma. J Am Acad Dermatol. 2010 Jun;62(6):962-7. doi: 10.1016/j.jaad.2009.06.067. Epub 2010 Apr 15.
PubMed 20398959
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Assessment of the Atrophogenic Potential of Triple Combination Cream Using Histology Measures in the Treatment of Moderate to Severe Melasma
- ClinicalTrials.gov ID
- NCT00469183
- Acronym / sponsor ID
- US10010
- Conditions
- Melasma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 4 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate atrophogenic potential of long-term use of Tri-Luma Cream on facial Melasma through biopsy examination.
Detailed description
Same as above.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects must have a clinical diagnosis of moderate to severe melasma
- Subjects willing to undergo biopsy four times throughout the study, two biopsies at baseline (one in a melasma involved area and one in a non-involved area). The third and fourth biopsies will be performed at 3 months and 6 months, respectively; in order to avoid variability in histopathological findings,
- Subjects must have substantial melasma involvement of the cheeks and be willing to have the same general site biopsied at the baseline, month 3 and month 6 visits.
Key exclusion criteria (6 listed)
- Subjects with diagnosis of dermal melasma
- Subjects who foresee intensive UV exposure during the study (mountain sports, UV radiation, sunbathing, etc.)
- Subjects who have used retinoids, steroids, and/or skin lightening products 4 weeks prior to study entry
- Subjects who show signs of Poikiloderma of Civatte (mandibular hyperpigmentation)
- Subjects with a history of hypertrophic scarring or a history of keloids
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 .1%, hydroquinone 4%, tretinoin .05%Also: TriLuma CreamApply topically daily for 12 weeks and continue until condition is clear or almost clear for up to 24 weeks; Maintenance phase: Apply topically twice weekly until the end of study (24 weeks) or condition relapses | Drug | – |
Primary outcome
Safety - Skin biopsy evaluation - histological assessment of skin atrophy
Time frame: Baseline, 12 weeks and 24 weeks
1 secondary outcome
Tolerability assessments; Incidence of adverse events; Global Assessment of Lesion Severity; MASI; Physician Global Assessment
Time frame: Baseline, 12 weeks and 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
- Derived from this study: PubMed 20398959Grimes PE, Bhawan J, Guevara IL, Colon LE, Johnson LA, Gottschalk RW, Pandya AG. Continuous therapy followed by a maintenance therapy regimen with a triple combination cream for melasma. J Am Acad Dermatol. 2010 Jun;62(6):962-7. doi: 10.1016/j.jaad.2009.06.067. Epub 2010 Apr 15.
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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.
Ronald 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 .1%, hydroquinone 4%, tretinoin .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 3 inclusion and 6 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: finished, as of the sponsor's last update on 29 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety - Skin biopsy evaluation - histological assessment of skin atrophy (time frame: Baseline, 12 weeks and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00469183, which also lists 1 linked publication.
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 29 Jul 2022.