TRI-LUMA (Page 3 of 5)

14 CLINICAL STUDIES

Two adequate and well-controlled efficacy and safety trials were conducted in 641 subjects between the ages of 21 to 75 years, having Fitzpatrick Skin types I-IV and moderate to severe melasma of the face. TRI-LUMA Cream was compared with 3 possible combinations of 2 of the 3 active ingredients [(1) hydroquinone 4% (HQ) + tretinoin 0.05% (RA); (2) fluocinolone acetonide 0.01% (FA) + tretinoin 0.05% (RA); (3) fluocinolone acetonide 0.01% (FA) + hydroquinone 4% (HQ)], contained in the same vehicle as TRI-LUMA Cream. Subjects were instructed to apply their study medication each night, after washing their face with a mild soapless cleanser, for 8 weeks. Instructions were given to apply a thin layer of study medication to the hyperpigmented lesion, making sure to cover the entire lesion including the outside borders extending to the normal pigmented skin. Subjects were provided a mild moisturizer for use as needed. A sunscreen with SPF 30 was also provided with instructions for daily use. Protective clothing and avoidance of sunlight exposure to the face was recommended.

Subjects were evaluated for melasma severity at Baseline and at Weeks 1, 2, 4, and 8 of treatment. Primary efficacy was based on the proportion of subjects who had an investigators’ assessment of treatment success, defined as the clearing of melasma at the end of the eight-week treatment period. The majority of subjects enrolled in the two trials were white (approximately 66%) and female (approximately 98%). TRI-LUMA Cream was demonstrated to be significantly more effective than any of the other combinations of the active ingredients.

PRIMARY EFFICACY ANALYSIS:

Table 2. Investigators’ Assessment of Treatment Success * At the End of 8 Weeks of Treatment
*
Treatment success was defined as melasma severity score of zero (melasma lesions cleared of hyperpigmentation)
TRI-LUMA HQ+RA FA+RA FA+HQ
Trial 1 Subjects, n 85 83 85 85
Successes, n 32 12 0 3
Proportion of Successes 38% 15% 0 4%
p-value ‹ 0.001 ‹ 0.001 ‹ 0.001
Trial 2 Subjects, n 76 75 76 76
Successes, n 10 3 3 1
Proportion of Successes 13% 4% 4% 1%
p-value 0.045 0.042 0.005

p-value is from Cochran-Mantel-Haenszel chi-square statistics controlling for pooled investigator and comparing TRI-LUMA Cream to the other treatment groups.

In the Investigators’ assessment of melasma severity at Day 56 of treatment, the following table shows the clinical improvement profile for all subjects treated with TRI-LUMA Cream based on severity of their melasma at the start of treatment.

Table 3. Investigators’ Assessment of Change in Melasma Severity from Baseline to Day 56 of Treatment (combined results from trials 1 and 2)
*
Assessment based on subjects with severity scores at Day 56. Percentages are bases on the total number in the treatment group population.
Does not include subjects who cleared before Day 56 or were missing from the Day 56 Assessment
Number (%) of Subjects at Day 56*
Baseline Cleared Mild Moderate Severe Missing
Severity Rating n n (%) n (%) n (%) n (%) n (%)
TRI-LUMA Cream N=161 Moderate 124 36 (29) 63 (51) 18 (15) 0 (0) 7 (6)
Severe 37 6 (16) 19 (51) 9 (24) 2 (5) 1 (3)

Assessment Scale: Cleared (melasma lesions approximately equivalent to surrounding normal skin or with minimal residual hyperpigmentation); Mild (slightly darker than the surrounding normal skin); Moderate (moderately darker than the surrounding normal skin); Severe (markedly darker than the surrounding normal skin).

Subjects experienced improvement of their melasma with the use of TRI-LUMA Cream as early as 4 weeks. However, among 7 subjects who had clearing at the end of 4 weeks of treatment with TRI-LUMA Cream, 4 of them did not maintain the remission after an additional 4 weeks of treatment.

After 8 weeks of treatment with the trial drug, subjects entered into an open-label extension period in which TRI-LUMA Cream was given on an as-needed basis for the treatment of melasma. The remission periods appeared to shorten between progressive courses of treatment. Additionally, few subjects maintained complete clearing of melasma (approximately 1 to 2%).

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