A Single-Center, Split-Face, Double-Blind, Randomized Clinical Trial of the Efficacy of a Trolamine-Containing Topical Emulsion
and a Topical Petrolatum-Based Product In Reducing Redness and Peeling After Treatment With a Microlaser Peel

Michael H. Gold, MD, Gold Skin Care Center, Tennessee Clinical Research Center, Nashville, TN ,USA

showed no improvement in peeling while PBO showed complete resolution. However, the TCTE side showed no peeling at all for the second treatment, while the PBO side showed reduced peeling for treatment two. The median statistic may not be sensitive enough to show subtle variations, given the small sample size.

Reduction in peeling was seen for TCTE in the second seven-day period only, while both products showed significant reductions in crusting during that same period. Overall reduction in skin scores for both products during both periods was significant. Given the small sample size, the small numbers used for scoring, and the small amount of blistering and crusting observed throughout the study period, results for blistering and crusting may be due to random variation.

Investigator endpoint analysis: Median improvements in skin characteristics are shown graphically in Figure 4. Although the differences between the 30-day and 60-day improvement levels did not reach statistical significance, a definite trend toward greater improvement

after the second treatment is suggested for all skin characteristics except hyperpigmentation.

Subject Assessments

Global Facial Skin Quality: Subjects graded facial dryness, oiliness, skin texture, pore size, skin thickness, skin properties, and capillaries; eye-area lines and wrinkles; lip-area lines and wrinkles; and cheek skin at baseline, day 30, and day 60. Differences in each characteristic on day 30 (after a single microlaser peel treatment on day 0 and application of products daily on days 1 through 7) and day 60 (after the second microlaser peel treatment on day 30 and application of products daily on days 31 through 37) from baseline were not significant (P>0.05). When baseline, 30-day, and 60-day assessments were collated (for all characteristics) and compared, differences from baseline were significant (p = 0.0036).

Skin Quality Improvement: The number of subjects reporting improvement and differences with TCTE at 30 days and at 60 days did not differ significantly from the number of subjects reporting improvement with PBO at

30 days and at 60 days, respectively (P>0.05). With either product, the number of subjects reporting improvement or differences at 30 days did not differ significantly from the number of subjects reporting improvement at 60 days (P>0.05). The data are shown in Table 1.

DISCUSSION

Designed to provide a moist, occluded healing environment for epidermal wounds, TCTE has been shown to promote macrophage migration across the wound bed,² and is currently the standard for post-radiation dermatitis.⁵

The results of this study show that TCTE, when used to accelerate resolution of redness and peeling after treatment with the microlaser peel, appears to be at least equivalent to PBO. Comparative studies with larger sample sizes are required to confirm this trend. Inclusion of a no-treatment arm in future investigations may provide additional insight. A future study might be to compare the costs to use these products.

CONCLUSION

TCTE appears to be at least equivalent to PBO in resolving redness and peeling produced by treatment with a microlaser peel.

REFERENCES

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2. Coulomb B, Friteau L, Dubertret L. Biafine applied on human epidermal wounds is chemotactic for macrophages and increases the IL-1/IL-6 ratio. Skin Pharmacol. 1997;10(5-6):281-287.

3.Fisher J, Scott C, Stevens R, et al. Randomized phase III study comparing Best Supportive Care to Biafine as a prophylactic agent for radiation-induced skin toxicity for women undergoing breast irradiation: Radiation Therapy Oncology Group (RTOG) 97-13. Int J Radiat Oncol Biol Phys. 2000;48(5):1307-1310.

4. Szumacher E, Wighton A, Franssen E, et al. Phase II study assessing the effectiveness of Biafine cream as a prophylactic agent for radiation-induced acute skin toxicity to the breast in women undergoing ra d i o t h e ra py with concomitant CMF chemotherapy. Int J Radiat Oncol Biol Phys. 2001;51(1):81-86.