Several studies have been discussed and overviewed (60). For example, in an open-label, one-month study with a DMAE-containing formulation (DMAE dose not specified), the skin of 50 subjects was compared at the end of the treatment period versus baseline by dermatologist grading and subject self-assessment. Significant improvements were reported in several measures, particularly in the area of skin firming and lifting. The topical treatment was well tolerated by the subjects. As a further example, in a double-blind, placebo – controlled, 16-week, full-face study (n=156), 75% of the subjects used a DMAE – containing formulation (DMAE dose not specified), and 25% of the subjects used aplacebo formulation (60). Effects were determined based on dermatologist grading and image analysis. The statistical p value presentation indicates several facial benefits related to skin firming (e. g., under-eye firming, cheek area firming, jaw line lifting and firming, increased elasticity, etc.). Again, the skin tolerated the DMAE formulation well. These reported observations are consistent with other small-base (n= 8) clinical testing showing improved skin firmness instrumentally from topical use of 3% DMAE in a one-day study (63).
The interesting aspect of the clinical effects is that while some testing has been weeks/months in duration, the onset of the benefit was reported to be very rapid, within minutes of topical application (60,63). This seems consistent with the suggested mechanism if sufficient DMAE can penetrate into skin and be converted to acetylcholine in such a short time period.
DMAE, a base, has historically been used as a formula pH adjusting agent. In the unneutralized state, its pH is approximately 10. Thus, pH adjustment to the desired value appears to be sufficient.