NCT00472966

Brief Summary

To determine the effectiveness and safety of sequential therapy with of Tri-Luma® Cream and a series of Glycolic Acid peels in treatment of moderate to severe melasma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2006

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 10, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 14, 2007

Completed
Last Updated

July 29, 2022

Status Verified

March 1, 2008

Enrollment Period

5 months

First QC Date

May 10, 2007

Last Update Submit

July 28, 2022

Conditions

Melasma

Outcome Measures

Primary Outcomes (1)

  • Efficacy - Improvement in Investigator's global assessment of melasma

    12 weeks

Secondary Outcomes (1)

  • Safety - Tolerability assessments and adverse event reporting

    12 weeks

Study Arms (1)

1

OTHER

Fluocinolone acetonide 0.1%/hydroquinone 4%/tretinoin 0.05% Cream in sequence with glycolic acid peels

Drug: Fluocinolone acetonide 0.1%/hydroquinone 4%/tretinoin 0.05% Cream in sequence with glycolic acid peels

Interventions

Fluocinolone acetonide 0.1%/hydroquinone 4%/tretinoin 0.05% Cream in sequence with glycolic acid peelsDRUG

Apply cream once daily at night. Subjects will be asked to discontinue use of Fluocinolone acetonide/hydroquinone/tretinoin Cream 2 days prior to the peel and restart 2 days after the peel; Glycolic Acid Peels - In office treatment at weeks 2, 4, 6, 8 and 10

Also known as: Tri-Luma® Cream, NeoStrata® Glycolic Acid Skin Renewal Peel
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects diagnosed with moderate to severe melasma

You may not qualify if:

  • Subjects under treatment for a dermatologic condition, which may interfere with the safe evaluation of the study combination (e.g. eczema, psoriasis, severe sun-damage, dermatitis)
  • Subjects with a diagnosis of skin cancer (BCE, SCC, Melanoma) in the areas to be treated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Skin Care Research, Inc.

Boca Raton, Florida, 33486, United States

Location

MeSH Terms

Conditions

Melanosis

Interventions

Fluocinolone AcetonidehydroquinoneTretinoinBase Sequence

Condition Hierarchy (Ancestors)

HyperpigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

PregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedVitamin ARetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesDiterpenesPigments, BiologicalBiological FactorsMolecular StructureBiochemical PhenomenaChemical PhenomenaGenetic StructuresGenetic Phenomena

Study Officials

  • Ronald W Gottschalk, MD

    Galderma R&D

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 10, 2007

First Posted

May 14, 2007

Study Start

November 1, 2006

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

July 29, 2022

Record last verified: 2008-03

Locations

US(1)