An open-label study of the efficacy and tolerability of microencapsulated hydroquinone 4% and retinol 0.15% with antioxidants for the treatment of hyperpigmentation.

Hyperpigmentation describes areas of the skin with increased melanin content, when the pigmentation is darker than the healthy surrounding skin. Disorders of hyperpigmentation, such as melasma, postinflammatory hyperpigmentation (PIH), and solar lentigines, are common and pose a treatment challenge for all patients, particularly those with darker skin types whose melanocytes are more reactive to various stimuli. Although distressing when affecting the face and areas of the body that are difficult to conceal, disorders of hyperpigmentation can affect individuals from head to toe. An innovative product containing microencapsulated hydroquinone 4% and retinol 0.15% with antioxidants has improved hyperpigmentation disorders of the face based on disease severity, pigmentation intensity, lesion area, and colorimetric measurements. The objective of the current open-label study was to evaluate the efficacy and tolerability of microencapsulated hydroquinone 4% and retinol 0.15% with antioxidants in individuals with Fitzpatrick skin types II through VI with hyperpigmentation of the face and/or body and to determine if this hydroquinone preparation was as effective on the body as it was on the face. Participants were treated twice daily for 12 weeks. Study evaluations were conducted at baseline and weeks 4, 8, and 12. Results from the efficacy assessments demonstrated that reductions in lesion size, darkness, and disease severity were significant as early as 4 weeks after treatment initiation and remained significantly reduced throughout the study (all P < .032). Furthermore, 63% of participants (12/19) had either marked improvement (defined as 75% overall improvement) or complete clearing (> or = 95% overall improvement) of their hyperpigmented lesions at the end of the 12-week treatment period. Reflectance spectrophotometer readings also were performed at each study visit and demonstrated a significant reduction in melanin content as early as week 4 (target A, P < or = .001; target B, P = .002).