Two products developed for treating facial hyperpigmentation in women with skin of color were compared head-to-head in a 12-week, randomized, double-blind clinical trial. Similar improvements were achieved at all follow-ups in multiple assessments among women using a hydroquinone-based product and those randomized to apply a cream containing vitamins A, C and E.
National report - Results of a randomized, double-blind clinical trial demonstrate the efficacy and safety of an over-the-counter hydroquinone fade cream and another cream without hydroquinone for reducing facial hyperpigmentation in patients with skin of color.
The trial enrolled adult women with Fitzpatrick skin types IV-VI, who had at least two facial hyperpigmentation lesions of at least moderate severity.
The participants were randomized to twice-daily treatment with a fade cream containing hydroquinone 2 percent plus vitamin E, alpha hydroxyl acid and a sunscreen (AMBI Fade Cream), or to an alternate cream product formulated with vitamins A, C and E (AMBI Even & Clear Targeted Mark Minimizer).
Treatment continued for 12 weeks, and the clinician and patients assessed responses after two, four, eight and 12 weeks. The results showed both products were well-tolerated and provided rapid improvement.
Statistically significant changes from baseline in clinician assessments of global facial hyperpigmentation and gradings of lesion darkness and size were noted within two weeks, and the benefits continued to increase with ongoing treatment.
There were no significant differences between the two treatment groups in any of the clinician assessments at any follow-up visit.
Patient satisfaction rates with their outcomes were high for both products, although the patient assessments suggested some superiority of the hydroquinone product.
"Hydroquinone continues to be a gold-standard treatment for hyperpigmentation. It is widely used in the United States in the form of both over-the-counter and prescription products, because physicians recognize and patients appreciate its benefits.
"However, we were pleased to document attainment of clinically significant improvement using a 2 percent hydroquinone preparation to further document its efficacy in the scientific literature," says Warren Wallo, M.S., associate director of scientific affairs, J&J CPPW.
"We were also happy to see similar improvements could be achieved using the vitamin A, C and E cream. These data suggest it can be a valuable alternative for treating hyperpigmentation in countries where hydroquinone is not available.
"Furthermore, either of these nonprescription products can provide a more affordable alternative to help address an important issue for patients who do not have prescription medication insurance benefits," Mr. Wallo tells Dermatology Times.
At study completion, two-thirds to almost 90 percent of women using the hydroquinone cream provided affirmative responses to questions asking them whether their skin pigmentation was more even, their skin looked better overall, and the product worked fast to clear up their skin discoloration.
More than half of the women using the hydroquinone product also indicated that their skin discolorations appear unnoticeable.
In the group using the vitamin A, C and E cream, the proportions of women who responded positively to the four statements on product performance ranged from 42 percent to 68 percent.
"We did not pursue a split-face design in this study, because it can be difficult to get bilateral symmetry with hyperpigmented lesions, Mr. Wallo says.
However, he says, "We would like to investigate this difference further in a future study with a split-face design trial that would allow us to probe deeper for any product preference and the underlying reasons for it."
He also underscores the importance of including daily use of a broad-spectrum, photostable, SPF 30+ sunscreen.
"Using an appropriate sunscreen alone won't fade hyperpigmented lesions, but it will help prevent redarkening and maintain some of the benefits resulting from use of a lightening product," Mr. Wallo says.
Disclosure: The study was sponsored by Johnson & Johnson Consumer and Personal Products Worldwide (Division of J&J CCI).