Treatment w/ Tri-Luma® Cream & Intense Pulsed Light (IPL) vs a Mild Inactive Control Cream & Intense Pulsed Light (IPL) in Melasma

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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00669071

Enrollment

Registered

2008-04-29

Start date

2008-01-31

Completion date

2008-10-31

Last updated

2022-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melasma

Brief 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.

Detailed description

Same as above.

Interventions

DRUGFluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%

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.

DRUGCetaphil® Moisturizing Cream as Inactive Control

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 design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 74 Years

Healthy volunteers

Inclusion criteria

* 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.)

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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
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
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
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
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
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

Countries

United States

Participant flow

Recruitment details

Dates of recruitment period: First subject was enrolled on January 8, 2008 and the last subject was enrolled on August 6, 2008.

Pre-assignment details

The specified wash-out period up to baseline was: * 2 weeks since the use of Non-Steroidal Anti- Inflammatory Drugs (NSAIDs) * 14 days for melasma treatments at the time of study entry or under current treatment * at least 6 months since prior facial IPL, resurfacing, deep or chemical peels from the date of study entry

Participants by arm

Arm	Count
IPL / Tri-Luma® Cream and IPL / Inactive Control Cream Intense Pulsed Light (IPL)/fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% cream (Tri-Luma® Cream) and Intense Pulsed Light (IPL)/Cetaphil® Moisturizing 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.	56
Total	56

Arm

Count

IPL / Tri-Luma® Cream and IPL / Inactive Control Cream

Intense Pulsed Light (IPL)/fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% cream (Tri-Luma® Cream) and Intense Pulsed Light (IPL)/Cetaphil® Moisturizing 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.

Total

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Final visit 40 days out of window	1
Overall Study	Lost to Follow-up	3

Baseline characteristics

Characteristic	IPL / Tri-Luma® Cream and IPL / Inactive Control Cream
Age, Continuous	43.3 years STANDARD_DEVIATION 9
Sex: Female, Male Female	56 Participants
Sex: Female, Male Male	0 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	0 / 56
serious Total, serious adverse events	0 / 56

Outcome results

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

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

Time frame: Baseline to week 10