Efficacy and Safety of Therapy With Tri-Luma® Cream in Sequence With Glycolic Acid Peels for Melasma
Completed
Galderma Laboratories, L.P.
Phase 4
2006-11-01
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.
Treatment w/ Tri-Luma® Cream & Intense Pulsed Light (IPL) vs a Mild Inactive Control Cream & Intense Pulsed Light (IPL) in Melasma
Terminated
Galderma Laboratories, L.P.
Phase 4
2008-01-01
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.
Solar Lentigines Treatment With the Triple Combination Cream
Completed
Galderma Laboratories, L.P.
Phase 2
2008-08-01
Background
- Lentigines are usually the first sign of photoaging and may produce a significant impact
on patients' quality of life.
- There is no a treatment of choice for this condition.
- Solar lentigines and melasma share similar physiopathologic characteristics.
- The triple combination (TC) cream (hydroquinone 4%, tretinoin 0.05%, and fluocinolone
acetonide 0.01%) has been effective and safe for the treatment of melasma and other
hyperpigmented lesions.
Hypothesis
* The TC cream will be effective and safe for the treatment of solar lentigines on the back
of the hands.
Patients and methods
- 22 patients with solar lentigines were selected and their right hand or left hand were
selected at random to be treated with either TC cream or tretinoin 0.05% cream once
daily for up 12 weeks.
- Patients were instructed to apply both creams on the whole back of the hand and not only
in the lentigines, and to use a broad-spectrum sunscreen (SPF 50+, UVA-PF 28) daily in
both hands.
- Clinical assessments of Target Lesion Pigmentation, Physician's Global Assessment of
Improvement and a Subject's Self-Assessment questionnaire were collected for data
analysis at weeks 4, 8, and 12 after starting the treatment and 3 month post-treatment.
- Statistical methods: The ordinally scaled efficacy measures underwent rank
transformation and were analyzed by analysis of variance to test the null hypothesis of
no differences among treatments. We performed Mann-Whitney and Wilcoxon tests and the
XLSTAT 2009 software was used.
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