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A randomized bilateral vehicle-controlled study of eflornithine cream combined with laser treatment versus laser treatment alone for facial hirsutism in women

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Background and Objective

Although there are a multitude of therapeutic modalities for removing unwanted facial hair in women, there is very little information on using the newer medical treatment approaches in combination. This study was designed to determine whether topical eflornithine can enhance the efficacy of laser hair removal.

Design

This was a randomized, double-blind, placebo-controlled, right-left comparison study of eflornithine cream combined with laser treatment versus laser alone for treating unwanted hair on the upper lip in women. All subjects underwent treatment to the entire upper lip with a long pulse alexandrite laser (10-40 ms pulse duration) at fluences of 7 to 40 J/cm2. Laser treatments were performed every 4 weeks for up to 6 sessions. Each patient also applied either eflornithine or placebo cream twice daily to each side of the upper lip in a double-blinded manner. Subjects were evaluated for safety by recording adverse events and for efficacy via (1) investigator global scoring, (2) patient self assessment, and (3) hair count analysis.

Results

Both treatment modalities were well tolerated by the 31 evaluable patients. All 3 outcome measures showed significantly better results in favor of eflornithine plus laser versus laser treatment alone. At the end of the study, complete or almost complete hair removal was achieved in 29 of 31 (93.5%) of the eflornithine-laser–treated sites versus 21 of 31 (67.9%) for the placebo cream-laser–treated sites (P = .021, McNemar test). Statistically significant differences in favor of eflornithine were likewise demonstrated at the final assessment through blinded patient grading (13/31 patients [41.9%] thought that the eflornithine was superior to placebo, P = .029, Poisson regression) and hair count analysis (P < .01, paired t test).

Limitations

This is a single-center study that did not determine whether the differences noted above last beyond 6 months.

Conclusions

On the basis of both investigator and patient assessments and hair count analysis, we have demonstrated that the addition of eflornithine to laser hair removal results in a more rapid and complete reduction of unwanted facial hair in women when the combination is used for up to 6 months.

Section snippets

Study subjects

The investigational protocol was approved by the University of British Columbia Clinical Research Ethics Board. Women aged 18 years or older with unwanted facial hair who carried out hair removal of any kind to their upper lip at least twice a week were enrolled. The upper lip was used for this study because it is a common site for unwanted hair and because this area can be well delineated for bilateral comparison purposes. All subjects had to have predominately dark facial hair that could be

Patient demographics

Of the 33 female subjects enrolled in this study, 31 were able to complete it in full, and the results are based on these subjects. One of the 33 patients withdrew from the study as a result of hyperpigmentation that developed after the second laser treatment, and another subject was lost to follow-up after the first laser treatment. The age range was 22 to 65 years with a mean of 40.5 years. Fitzpatrick skin types were distributed as follows: 10 patients (30.3%) had type II; 7 type III

Discussion

The primary objective of our study was to explore whether a combination of physical (laser) and pharmacologic (topical eflornithine) methods would be superior to laser alone for treating unwanted facial hair in women. We also aimed to determine the safety profile and establish practical guidelines for this combined approach to hair removal. In our cohort, hair reduction was serially assessed after each successive laser treatment for up to 24 weeks using 3 separate outcome measures. Two of these

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There are more references available in the full text version of this article.

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    Citation Excerpt :

    It is recommended to use twice daily and can also be combined with laser treatment. In a study Eflornithine cream combined with laser treatment for a period of 6 months enhanced the efficacy of hair removal with rapid and complete reduction of facial hair [131]. This study was further supported by Stacy et al., which demonstrated rapid hair removal of Eflornithine when combined with laser treatment [132].

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Funding sources: None.

Disclosures: Dr Lui has been a speaker for Barrier Therapeutics Canada. Dr Hamzavi has been a speaker for Shire Pharmaceuticals and SkinMedica. Dr Shapiro is a speaker for Shire Pharmaceuticals and Barrier Therapeutics Canada and has served as a consultant for SkinMedica.

Previously presented in part at the annual meeting of the American Society for Laser Medicine and Surgery, Anaheim, California, April 2003.

Dr Hamzavi is currently affiliated with the Henry Ford Hospital, Detroit, Michigan. Dr Hamzavi and Dr Tan contributed equally to the production of this manuscript.

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