Blockade of melanin synthesis, activation and distribution pathway by a nonprescription natural regimen is equally effective to a multiple prescription-based therapeutic regimen.

Background: Disorders characterized by cutaneous hyperpigmentation (HP) are among the most common complaints in dermatologists' offices. These patients are also some of the most difficult to treat since current therapeutic regimens have high irritation rates and mediocre efficacy. Moreover, current regimens have the potential to induce post-inflammatory HP (PIH), a secondary disease that is more difficult to treat.

Objective: To measure the effectiveness of a novel blend of primarily natural ingredients that inhibits all but one of the steps in melanin synthesis, activation and distribution. Three common types of HP were treated and compared with one of the most commonly prescribed available regimens. This comprises two prescription products and two nonprescription products containing known depigmenting lightening ingredients.

Materials And Methods: The initial trial consisted of 56 females of 3 different races were treated in a 3-armed parallel, investigatorblinded prospective controlled clinical trial of 18 weeks duration. The treatment phase was 12 weeks long, followed by a 6 week, nontreatment regression phase. This trial was conducted in the winter at over 6,000 feet above sea level. The natural ingredient (NI) blend consists of two cosmeceutical products together containing 22 ingredients. A second 1-year open trial of 31 panelists of 3 races was instituted to document continual improvement using both NI products without irritation and sensitization.

Results: The novel herbal blend regimens had comparable efficacy in treating HP and preventing rebound of mottled HP, dyschromia and melasma as the commercial regimen containing two prescription products. The 12-month open study demonstrated continued visible improvement of the HP with NI regimens without irritation and sensitization.

Conclusion: The novel primarily natural ingredient product regimens are equally effective in treating three types of cutaneous HP as is a regimen containing prescription hydroquinone 4%, tretinoin 0.05% and two nonprescription leave on products.