Abstract:
Objectives: In this pilot study, our intention was to ascertain what formulation of a carbohydrate-derived fulvic acid (CHD-FA) topical applicator was optimal for patients to use during a larger study where the efficacy of fulvic acid (CHD-FA) in treating moderate acne vulgaris will be investigated. Methods: 15 individuals with inflammatory acne with an acne grade of III or lower were asked to volunteer for the study. They were split into 3 groups. Each group was asked to use a different formulation (a cream base, gel base and wet applicator formulation) each week. After each week, the individuals returned to fill out a questionnaire evaluating the formulation they used that week. They were also examined by the clinician for any possible side effects, and given the next formulation to use for the following week. The trial was 3 weeks long, and after using all 3 formulations the individuals were asked to fill out a final questionnaire evaluating all 3 formulations. The clinician was also asked to fill out a questionnaire giving his/her opinion on the formulations. Results: The results did not give conclusive evidence of one particular formulation being favored above all the others. All the formulations performed more or less equally as well. According to the final questionnaire, 6 out of the 15 individuals were most satisfied with the wet applicator, 4 out of 15 preferred the cream base and 5 out of 15 preferred the gel base. 5 out of 15 individuals were least satisfied with the wet applicator, 3 out of 15 with the cream base, and 7 out of 15 were least satisfied with the gel. While there was no conclusive indication for one particular formulation, there were some common complaints or observations by individuals about each formulation. Most individuals said the wet applicator had an initial burning sensation to the skin upon application, but it disappeared a few seconds after application. Many individuals said they felt the cream base was oily and made the skin appear oily after application. The gel base was said to smell the worst, along with the wet applicator, while the cream smelt the least. A few individuals complained that the gel left a residue on the skin. Conclusion: While the study did not give a clear indication of one particular formulation that was preferred by individuals, it did produce interesting results that can be used to make some of the formulations more favourable. In the main trial, further investigation will be done to optimize the formulation.
