Efficacy and Tolerability of Two Commercial Hyperpigmentation Kits in the Treatment of Facial Hyperpigmentation and Photo-Aging
August 2012 | Volume 11 | Issue 8 | Original Article | 964 | Copyright © August 2012
Sabrina Fabi MD, Ane B. Niwa Massaki MD, and Mitchel P. Goldman MD
Goldman, Butterwick, Fitzpatrick, Groff, & Fabi, Cosmetic Laser Dermatology, San Diego, CA
Abstract
Background: Hyperpigmentary disorders are common aesthetic skin conditions that can be very concerning to patients and both challenging and time-consuming for the physician to treat. Several companies commercialize hyperpigmentation kits for the lightening of dark spots and improvement of overall skin dyschromia. Unfortunately, clinical data from controlled studies to support the efficacy and tolerability of these kits are typically lacking
Objective: This investigator-blinded, randomized trial was undertaken to compare two commercial hyperpigmentation systems (kits) used for the treatment of facial hyperpigmentation and photo-aging.
Methods: Female subjects with at least mild facial hyperpigmentation and photo-aging were randomized to treatment with either the four product SkinMedica (SKM) regimen or the 7-product Obagi (OMP) regimen. Evaluations were conducted at baseline, 4, 8, and 12 weeks. Subjects were evaluated by the blinded investigator for clinical efficacy and tolerability using grading scales. Standardized digital photographs were taken at baseline and week 12. Self-assessment questionnaires were completed at week 12. Thirty-five females (SKM=17, OMP=18) completed the 12-week study.
Results: Both treatment regimens showed a significant improvement at week 12 (compared to baseline) for Overall Hyperpigmentation, Global Photo-aging and Sallowness. At week 12, there was no significant difference between treatment groups in Global Response to Treatment. Tolerability was good for both regimens based on investigator assessments. Subject self-assessments showed no consistent differences in efficacy between the two regimens. Similarly, there was no significant difference in subject satisfaction or intent to continue use between the two regimens.
Conclusion: This clinical study demonstrated that both systems were equally effective at reducing hyperpigmentation and global photo-aging in females with mottled pigmentation and photodamaged facial skin.
J Drugs Dermatol. 2012;11(8):964-968.
INTRODUCTION
Disorders of hyperpigmentation including melasma, solar lentigines, ephelides, postinflammatory hyperpigmentation (PIH), mottled pigmentation, and dyschromia of
photo-aging are conditions commonly seen in clinical dermatology practices. These pigmentary disorders can be both very distressing for patients and extremely
challenging for the clinician to treat. While there are numerous treatment modalities available, topical hydroquinone (HQ) remains the gold standard for such
pigmentary disorders. Hydroquinone has been used as a skin lightener for over 50 years and multiple clinical studies have documented its efficacy in various
formulations.1-5 Hydroquinone is available in 2% formulations in many over-the-counter products and as a 4% prescription product and is rarely used alone in treating
pigmentary disorders, but rather is typically combined with other agents in a regimen. Hydroquinone remains widely used for skin lightening despite concerns
expressed regarding its safety from the FDA,6 presumably due to lack of any documented cases of either cutaneous or internal malignancy and extremely rare
occurrences of exogenous ochronosis in the United States.7-9
Vitamin A derivatives (eg, retinol, tretinoin) have also been shown effective in the treatment of hyperpigmentation and are increasingly being employed in
therapeutic regimens.10-14 These retinoids inhibit induced melanogenesis15,16 and enhance the depigmenting effects of HQ.17,18 In addition, topical retinoids modify
the stratum corneum, facilitating the penetration of molecules such as HQ into the epidermis.19
This study was conducted to assess the efficacy and tolerability of two commercial hyperpigmentation systems (kits) used for the treatment of facial
hyperpigmentation and photo-aging.
MATERIALS AND METHODS
The criteria for study participation included adult subjects aged 35 to 65 years, with Fitzpatrick skin types I-IV, with at least mild mottled hyperpigmentation of
the face (corresponding to a score of 2 or more on a 5-point Hyperpigmentation Scale), and photodamaged facial skin (score of 2 or above on a 5-point Global Photo-
aging Scale). Subjects must be willing to not use
