Among chemical treatments for controlling facial hair growth, Vaniqa remains the only FDA-approved product for this indication, and among the physical/photothermal methods, laser or light-based treatment is the only modality clinically proven for hair reduction. However, both these methods have certain limitations, the critical one being the level of hair reduction effectiveness. Though eflornithine is color blind, that is, works irrespective of skin and hair color, it has demonstrated only a modest level of efficacy, and though laser can be highly effective, its efficacy and safety is highly dependent on the subject’s hair and skin color. The two methods also suffer from a wide range in effectiveness, related in part to inherent technology and a broad range of hair character in the population. By combining these two modalities, one can achieve an efficacy synergy that is highly satisfactory to the consumer and the benefit readily perceptible.
Clinical studies have shown that Vaniqa treatment at the recommended twice daily dose can significantly enhance the hair-removal effectiveness of a laser treatment regimen. A randomized, double-blind and vehicle-controlled study was reported by Smith et al. using laser in combination with and without Vaniqa [68]. The study was conducted at two clinical sites in 54 women who had upper lip and chin hair. In this split-face comparison, patients applied Vaniqa on one side of the face and a placebo cream on the other side. Both sides were treated with a laser. The treatments were performed either with the alexandrite (18-30 J/cm2; 3 ms pulse) or the Nd:YAG system (30-50 J/cm2; 50-100 ms pulse). The laser parameters were selected based on the patient’s tolerability with the goal of administering a maximal tolerable dose. Subjects received two laser treatments, one at Week 2 and the second at Week 10. Subjects applied Vaniqa and the placebo cream twice a day on split – face for 34 week duration of the study. Physician’s Global Assessment score was used as the primary efficacy measure. The scoring system was similar to the one used in the Vaniqa phase-III clinical trials that supported its regulatory approval. The PGA scores were used to determine change from baseline, and to assess differences between the Vaniqa and the placebo-cream side. In addition, subject’s self-perceptions of their condition between the left and the right side were used to assess Vaniqa benefits. Results from the PGA scores indicated statistical differences favoring the Vaniqa side for both the upper lip and chin hair at most of the four time points evaluated between Week-6 and Week-22. There were no statistical differences for the PGA scores at Week 34 of the study, indicating a significant hair growth recovery in the 24-week period after the last laser treatment. Subjects, on the other hand, perceived significant differences favoring the Vaniqa side both for the upper lip and chin starting as early as Week-2 and lasting throughout the study to Week-34. One reason for the discrepancy could be that the subjects in their assessment took into account both the vellus and the terminal hair, whereas the PGA scoring was done strictly based on the presence of terminal hair. While laser affects primarily the terminal hair, and Vaniqa both terminal and vellus (both to a lesser degree) combining the two modalities seem to provide a consumer-perceptible benefit that is greater in magnitude than either treatment alone. In addition, the enhancement in efficacy for the combination was achieved without any observable increase in the dermal side effects. There were no significant differences in the types, rates, and severity of dermal adverse events between the Vaniqa and the placebo – cream side.
Another Vaniqa and laser combination clinical trial was conducted by Hamzavi et al. [69,70]. The study included 31 subjects, and was designed as a randomized, double-blind, placebo-controlled split-body test similar in design to the Smith study [68]. The subjects treated one side of their upper lip with Vaniqa and the other side with the placebo cream twice a day in a blinded manner, starting at the time of first laser treatment and continuing until two weeks after the last laser treatment. Both sides received treatment with an alexandrite laser. As compared to just two laser treatments in the Smith study [68], this study included up to six laser treatments performed at monthly intervals. The laser parameters of pulse duration (10-40 ms) and fluence (7-40 J/cm2) were varied depending on the subject’s tolerance and skin reaction; however, both sides on a given subject were treated with the same laser parameters to provide a within-subject comparison. Three efficacy measures used in the study—global scoring by the investigator, objective hair count and patient self-assessment of benefits, all showed a significant benefit difference between the laser and Vaniqa combination compared to laser alone. With the combination, a complete or nearly complete hair-removal efficacy was achieved in over 90% (29/31) of the subjects. On the side with the placebo cream and laser, the level of efficacy was seen in only 68% of the subjects (21/31). Neither study [68,69] had a group-comparing efficacy of Vaniqa alone (without laser). In the Vaniqa Phase-III testing, using a similar global scoring system 47% of the subjects showed a marked improvement or better in their facial hair condition [58]. For the laser/Vaniqa combination, in addition to the PGA scoring, the objective hair count and the patient self-assessment measures all showed a statistical difference favoring the Vaniqa side [59]. The study also demonstrated that the laser and Vaniqa combination results in a longer lasting “hair-free” period. There were no significant dermal adverse events or differences in dermal effects between the Vaniqa and the placebo cream sides.
Vaniqa and laser combination has also been evaluated for removal of gray hair, treatment of darker skin (Type V/VI) and for treating the PFB condition. In a case report, a patient with a mixture of gray and black hair showed a dramatic improvement with the combination of laser (diode) and Vaniqa [71]. Laser treatment alone had left a significant amount of gray hair and the combination of laser and Meladine, a pigment enhancer, also proved to be ineffective. In addition to working on gray hair, the laser/Vaniqa combination seems to work well for hair removal on Fitzpatrick skin types IV-VI. The issue with the darker skin is that lower laser fluences need to be used to maintain dermal safety. Combination of laser and Vaniqa has been described by Callender to be the most effective first-line therapy for the treatment of facial hair in skin types IV-VI [72]. The combination provided quicker results with much greater efficacy. In a retrospective study of 74 African American patients with facial hair who were treated with a combination of Vaniqa (twice daily) and Nd:YAG (long-pulsed or Q-switched), improvements were noted in the severity of hirsutism, PFB condition, and hyperpigmentation (PIH).