Improved quality of life with effective Treatment of Facial Melasma: the PIGMENT trial

Journal of Drugs in Dermatology, July-August, 2004 by R. Balkrishnan, A.P. Kelly, A. Mcmichael, H. Torok

Discussion

The results of the PIGMENT trial demonstrate that the FA HQ RA cream formulation is highly effective in the treatment of moderate to severe melasma, and these benefits translate into an improved quality of life. Significant decreases in the overall MASI Score. MASI Darkness Score, and MASI Homogeneity Score were apparent from baseline to week 4, and further reductions had occurred by week 8. Improvements were observed in all facial regions involved, as well as across all races/ethnicities and Fitzpatrick skin types. The treatment was safe and well tolerated.

The findings from the present study are consistent with the results of the previous randomized, controlled trials and confirm that the utility of FA HQ RA extends to the community setting. Moreover, the quality of life evaluations reveal that the efficacy of FA HQ RA translates into important psychological, emotional and lifestyle benefits for patients.

It is important that physicians be aware of the psychosocial impact of melasma on patients. In the survey of individuals with hyperpigmentation discussed above, some respondents did not feel that their disorder was sufficiently pronounced to mention it at a regular visit to the physician (9). Others have stated that the physician would have to initiate the conversation. Of particular concern, some respondents expressed the opinion that their physicians did not seem very sympathetic about their skin discoloration. Most patients did not believe that that there was any effective treatment for melasma.

In view of the results obtained with the FA HQ RA cream formulation in this and previous trials, both physicians and patients should be made aware that there is an effective treatment for melasma, that also improves the quality of life. Clinically significant (p<0.0001) clearing occurred in many patients by week 4, with further benefits at week 8. Moreover, this treatment is effective in patients of all races/ethnicities and Fitzpatrick skin types. Therapy with FA HQ RA is also safe and well tolerated, with a minimal risk of adverse effects.

Melasma is a readily apparent, potentially disfiguring condition that often causes patients great emotional distress, hinders social interactions, and can affect functioning at work or school (3,5-8,23). The FA HQ RA cream formulation represents a major advance in the treatment of this disorder, offering meaningful results that improve the quality of life.

Table 1. Demographics of study population

VARIABLE                                                  N     (%)

Gender                                                      [N=1287]
 Male                                                       46   (3.6)
Female                                                    1241  (96.2)
Not reported                                                 3   (0.2)
Race                                                        [N=1290]
 Caucasian                                                 800  (62.2)
Hispanic origin                                            204  (15.8)
African American/black                                     130  (10.1)
Asian                                                       94   (7.3)
American Indian/Alaskan Native/Pacific Islander             14   (1.1)
 Other                                                      43   (3.3)
Not reported                                                 5   (0.3)
Fitzpatrick skin type                                       [N=1260]
 I (always burns easily; never tans)                        21   (1.7)
 II (always burns easily; tans minimally and with          213  (16.9)
   difficulty)
 III (burns minimally; tans gradually and uniformly        415  (32.9)
   [light brown])
 IV (burns minimally; always tans well [moderate brown])   346  (27.5)
 V (rarely burns; tans profusely [dark brown])             191  (15.2)
 VI (rarely burns; tans deeply [black]; tans profusely)     72   (5.7)
 Not reported                                                2   (0.2)

Mean MASI Score

Baseline (n=1252)  14.68
Week 4 (n=1130)     7.38 *
Week 8 (n=1052)     3.64 *

* P < 0.0001 vs. baseline

Figure 1. Reductions in overall mean MASI scores from baseline to 4 and
8 weeks after initiation of treatment with the FA HQ RA cream
formulation.

Note: Table made from bar graph.

Table 2. Responses to questions regarding quality of life at baseline
and after 8 weeks of treatment with the FA HQ RA cream formulation

                                                    Baseline   Week 8
Question                                Response    n    (%)   n     (%)

"Over the last week ...
  ... how embarrassed or self-          Very much   202  (19)   21   (2)
  conscious have you been               A lot       258  (24)   50   (5)
  because of your skin?"                A little    419  (39)  353  (33)
                                        Not at all   96  (18)  650  (60)
  ... how much have people focused on   Very much    62   (6)   11   (1)
  your skin discoloration rather than   A lot       109  (10)   40   (4)
  on what you are saying or doing?"     A little    452  (42)  238  (22)
                                        Not at all  453  (42)  785  (73)
  ... how much has your skin            Very much   171  (16)   21   (2)
  discoloration made you feel           A lot       245  (23)   64   (6)
  unattractive to others?"              A little    455  (41)  320  (30)
                                        Not at all  214  (20)  699  (62)
  ... how much effort have you put      Very much   188  (18)   31   (3)
  into hiding your skin discoloration   A lot       297  (28)   88   (8)
  from others?"                         A little    392  (36)  455  (42)
                                        Not at all  196  (18)  500  (47)
  ... how much has your skin affected   Very much    57   (5)   12   (1)
  any of your social or leisure         A lot        99   (9)   20   (2)
  activities?"                          A little    274  (26)  153  (14)
                                        Not at all  644  (60)  889  (83)

% Improvement From Baseline

Less Embarrassed          64.1%
Used Fewer Cosmetics      52.4%
Less Effort to Hide Skin  56.3%
Felt Younger              60.4%
Felt More Attractive      61.2%

Figure 2. Percentages of patients with improvement in various quality of
life measures, from baseline to the completion of 8 weeks of treatment
with the FA HQ RA cream formulation.

Note: Table made from bar graph.