The effect of eflornithine 13.9% cream on the bother and discomfort due to hirsutism

Although unwanted facial hair often leads to anxiety and avoidance of social situations, evaluation of treatment outcomes in clinical trials has relied largely on measures external to the patient such as the extent of hair growth or an expert physician's assessment, neglecting to include patient reported outcomes (PRO). To assess the level of bother caused by a dermatological condition (hirsutism) and changes brought on by treatment, the instrument ESTEEM was developed by expanding the Bother Assessment in Skin Conditions (BASC) scale to six questions to cover the discomfort felt in four social situations and bother due to removing facial hair. Each question elicits responses on a visual analog scale. Women participating in two randomized clinical trials evaluated a new treatment (eflornithine 13.9% cream). Analyses examined the level of bother at each visit, the changes with treatment, the correlations with the Physician's Global Assessment, and the effect size. Hirsutism bothers patients considerably. The mean for overall bother was 89% and the mean discomfort in social situations exceeded 80% in nearly all cases. Treatment led to significant reductions in bother on all six items with effect sizes ranging from 0.46 to 1.62. Eflornithine is an effective treatment for unwanted facial hair in women, as reported by the patients. ESTEEM addresses the specific concerns of women with hirsutism.     

A 4-month, open-label study evaluating the efficacy of eflornithine 11.5% cream in the treatment of unwanted facial hair in women using TrichoScan

Eflornithine 11.5% cream is an effective treatment for unwanted facial hair (UFH) in women with the effect on facial hair growth starting to be seen from 1 month after treatment initiation. TrichoScan is a validated method of assessing hair length, thickness, density, and growth rate using contact skin microscopy. The study aimed to evaluate the efficacy of eflornithine cream in women with UFH, as assessed by TrichoScan.In this open-label, single-centre study, 25 women (aged 25-63 years) applied eflornithine 11.5% cream to the upper lip twice daily for 4 months. Hair density, mean and cumulative hair length, mean hair thickness and hair growth rate were assessed at baseline and Month 1, 2 and 4 using TrichoScan.Eflornithine cream significantly decreased hair density from baseline to Month 1 (- 11.4 hairs/cm2, p = 0.014), Month 2 (- 16.5 hairs/cm2, p = 0.013) and Month 4 (- 12.05 hairs/cm2, p = 0.05). In addition, cumulative hair length decreased from baseline to Month 1 (- 7.104 mm, p = 0.001), Month 2 (- 10.054 mm, p < 0.001) and Month 4 (- 8.061 mm, p = 0.001). There was also a significant decrease in hair growth rate. Mean hair thickness did not change significantly. Eflornithine 11.5% cream is an effective treatment for UFH in women with the effect on facial hair growth starting to be seen from 1 month after treatment initiation.     

Treatments for unwanted facial hair

Twenty-two percent of women in North America have unwanted facial hair, which can cause embarrassment and result in a significant emotional burden. Treatment options include plucking, waxing (including the sugar forms), depilatories, bleaching, shaving, electrolysis, laser, intense pulsed light (IPL), and eflornithine 13.9% cream (Vaniqa, Barrier Therapeutics in Canada and Shire Pharmaceuticals elsewhere). Eflornithine 13.9% cream is a topical treatment that does not remove the hairs, but acts to reduce the rate of growth and appears to be effective for unwanted facial hair on the mustache and chin area. Eflornithine 13.9% cream can be used in combination with other treatments such as lasers and IPL to give the patient the best chance for successful hair removal.     

Aktuelle Therapie der Hypertrichosen

Facial hypertrichosis and hirsutism may cause severe cosmetic and psychologic problems. In the following, new developments in the treatment of hypertrichosis will be presented. Permanent depilation by photothermolysis is currently the most promising treatment. A new topical treatment of hypertrichosis is eflornithine cream. It inhibits the enzyme ornithine decarboxylase which is essential for the rapidly dividing cells of the hair follicle. Furthermore, other methods of hair removal such as plucking, waxing, chemical depilation by thioglycolates, electrolysis, thermolysis and systemic therapies of hirsutism will be discussed.     

Hypertrichosis in females applying minoxidil topical solution and in normal controls

BACKGROUND: Hypertrichosis has been reported more frequently in females than in males who use minoxidil topical solution (MTS) for the treatment of androgenetic alopecia (AGA). This article examines the occurrence of MTS-induced hypertrichosis in females. METHODS: Data from placebo-controlled clinical trials in females (up to 5% MTS) were analysed based on spontaneous reports of hypertrichosis/facial hair and investigators' inquiries (solicited) about the presence of any new hair growth on body parts other than the scalp. A postmarketing drug surveillance database for MTS was also examined for reports of hypertrichosis/facial hair. RESULTS: In the clinical trials involving a total of 1333 females, spontaneous reports of hypertrichosis/facial hair were noted for 50 (4%) females in a dose-related pattern of response (5% MTS > 2% MTS > placebo). Nine females (seven and two in the 5% MTS and 2% MTS groups, respectively) discontinued treatment because of hypertrichosis/facial hair. Solicited reports of excessive hair growth (primarily facial) also showed a dose-related pattern of response. Post-marketing data showed a lower occurrence (0.5%) of hypertrichosis/facial hair than in the clinical trials. Of interest, in one clinical trial, 27% of the females enrolled (MTS and placebo treated) had facial hair growth reported at baseline. CONCLUSIONS: Females with some hirsutism are particularly prone to seek treatment for AGA, and this may explain the high occurrence of hypertrichosis/facial hair found in the MTS clinical trials. Furthermore, some demographic groups of females are prone to develop facial hair and the problem of unwanted facial hair growth seems to be underestimated. Some females may have hair follicles that are very sensitive to MTS and should use the lowest strength of MTS (2%) to help avoid unwanted hair growth. The hypertrichotic effect of MTS on other sites than the scalp, including the face, is reversible and does not always require discontinuation of therapy.     

Facial hirsutism treated with the normal-mode ruby laser: results of a 12-month follow-up study

Fifty-one patients of skin type I to IV with facial hirsutism received treatment with the normal-mode ruby laser (950-micros pulse; 4-mm spot; mean fluence, 49 J/cm(2); maximum fluence, 66 J/cm(2)). For each patient, one site was treated once only, and a second site was treated 4 times at 4-week intervals. After 48 weeks, 46 patients were available for assessment. After a single treatment, hair counts were reduced to a mean of 45% at 4 weeks (pretreatment median of 63 hairs down to 26), increased to 80% (median, 51 hairs) at 12 weeks, were 65% (median, 41 hairs) at 24 weeks, and were 59% (median, 35 hairs) at 48 weeks. Four weeks after 3 treatments, the hair counts had reduced to a mean of 30% (pretreatment median of 68 hairs down to 15). Twelve weeks after 4 treatments, the hair counts had increased to 45% (median, 24 hairs) and were 39% after 36 weeks (median, 22.5 hairs). No anesthesia was needed. Treatment tolerance improved with consecutive visits, allowing higher fluences to be used. Hyperpigmentation developed in 9 patients, which had faded completely in 8 patients at the end of the study. One patient showed hypopigmentation. Depressions in the skin below the jaw line developed in 5 patients, which resolved completely within 4 to 32 weeks. We conclude that normal-mode ruby laser treatment is well tolerated and leads to significant improvement of facial hirsutism, which is maintained for at least 48 weeks. Repeated treatments result in greater clinical effects.     

Medical treatment of hirsutism

Hirsutism is usually the result of an underlying adrenal, ovarian, or central endocrine abnormality mainly due to polycystic ovary syndrome but may also be idiopathic or drug induced. The aim of medical treatment of hirsutism is to rectify any causal hormonal balance, slow down or stop excessive hair growth, and improve the aesthetic appearance of hirsutism, thereby positively affecting the patient's quality of life. Today, for the majority of women, a monotherapy with oral contraceptives that have antiandrogenic activity is recommended as a first-line treatment for hirsutism. Combining an oral contraceptive pill with an antiandrogen is recommended if clinical improvement of hirsutism is insufficient after 6-9 months' monotherapy. In women who present with hirsutism, hyperandrogenism, and insulin resistance, insulin sensitizers are effective for the hirsutism as well as the hyperinsulinemia, hyperandrogenism, and infertility but there is no convincing evidence that they are effective for hirsutism alone. Topical eflornithine is a medical therapy that can be a useful adjuvant for hirsutism when used in conjunction with systemic medications or with laser/photoepilation.     

Skin academy: hair, skin, hormones and menopause - current status/knowledge on the management of hair disorders in menopausal women

Menopause is defined by 12 months of amenorrhea after the final menstrual period. The reduction in ovarian hormones and increased androgen levels can manifest as hair and skin disorders. Although hirsutism, unwanted facial hair, alopecia, skin atrophy and slackness of facial skin are common issues encountered by post-menopausal women, these problems receive very little attention relative to other menopausal symptoms. The visibility of these disorders has been shown to cause significant anxiety and may impact on patients' self-esteem and quality of life, particularly given the strong association of hair and skin with a woman's femininity and beauty, which is demonstrated by extensive marketing by the cosmetic industry targeting this population and the large expenditure on these products by menopausal women. The proportion of the female population who are in the post-menopausal age group is rising. Therefore, the prevalence of these dermatological symptoms is likely to increase. Current therapies aim to rectify underlying hormonal imbalances and improve cosmetic appearance. However, there is little evidence to support treatment for these disorders specifically in post-menopausal women. This review discusses the assessment and treatment of both the physiological and psychological aspects of hair and skin disorders pertinent to the growing post-menopausal population.     

Intense pulsed light treatment of hirsutism: case reports of skin phototypes V and VI

Removal of unwanted hair is a common cosmetic concern. For hirsute women, treatment often requires drug therapy and various methods to physically remove the hair. Traditional methods of hair removal include shaving, waxing, tweezing, depilatory creams and electrolysis. Hair removal methods based on light technology, such as lasers and intense pulsed light systems, are alternative methods for longer-term hair removal. Intense pulsed light has been used in our clinic during the past 2 years to treat light-to-dark skinned patients, including skin types V and VI. We present here the treatment, using an intense pulsed light source, of three dark skinned patients with hirsutism. Patients were treated during multiple sessions (five to seven) for unwanted facial hair. Sessions were conducted monthly and patients were evaluated at follow-up sessions 2-7 months after the final treatment. Successful clearance of unwanted hair was achieved in all three patients with no pigmentary changes observed during the final follow-up sessions. Folliculitis and hyperpigmentation from tweezing were also treated by the intense pulsed light source. These results suggest that intense pulsed light is an effective source for hair removal and may, with proper parameter selection, be useful in the treatment of very dark skin types.     

Intense pulsed light treatment of hirsutism: case reports of skin phototypes V and VI

Removal of unwanted hair is a common cosmetic concern. For hirsute women, treatment often requires drug therapy and various methods to physically remove the hair. Traditional methods of hair removal include shaving, waxing, tweezing, depilatory creams and electrolysis. Hair removal methods based on light technology, such as lasers and intense pulsed light systems, are alternative methods for longer-term hair removal. Intense pulsed light has been used in our clinic during the past 2 years to treat light-to-dark skinned patients, including skin types V and VI. We present here the treatment, using an intense pulsed light source, of three dark skinned patients with hirsutism. Patients were treated during multiple sessions (five to seven) for unwanted facial hair. Sessions were conducted monthly and patients were evaluated at follow-up sessions 2–7 months after the final treatment. Successful clearance of unwanted hair was achieved in all three patients with no pigmentary changes observed during the final follow-up sessions. Folliculitis and hyperpigmentation from tweezing were also treated by the intense pulsed light source. These results suggest that intense pulsed light is an effective source for hair removal and may, with proper parameter selection, be useful in the treatment of very dark skin types.     

A randomized double blind,vehicle controlled bilateral comparison study of the efficacy and safety of finasteride 0.5% solution in combination with intense pulsed light in the treatment of facial hirsutism*

Abstract

Objective: We sought to determine whether topical finasteride can enhance the efficacy of intense pulsed light hair removal. Materials and methods: An intense pulsed light (IPL) treatment with radiofrequency (RF) was performed every four weeks, resulting in up to three sessions, and again at the end of the study – 6 months after the start of the experiment. Each patient also applied either finasteride or placebo solution twice daily to each side of the chin in a double-blinded manner. Results: A total of 77 patients were included in the study. Mean hair density before treatment in finasteride side of the patient's chin was 19.7?±?11.7 and in placebo side was 19.1?±?11.3. After three sessions of IPL + RF treatment, combined with twice daily application of finasteride and placebo solutions, at the end of 6-month period mean hair density of 8?±?6.3 and 9?±?5.6 was achieved in finasteride and placebo side respectively. Statistically significant difference was found between finasteride and placebo solution. Conclusions: We have demonstrated that the addition of finasteride solution to IPL + RF hair removal may result in a more reduction of unwanted facial hair in women when the combination is used for up to 6 months.     

Polyamines and hair: a couple in search of perfection

Please cite this paper as: Polyamines and hair: a couple in search of perfection. Experimental Dermatology 2010; 19 : 784–790. Abstract: Polyamines (spermidine, putrescine and spermine) are multifunctional cationic amines that are indispensable for cellular proliferation; of key significance in the growth of rapidly regenerating tissues and tumors. Given that the hair follicle (HF) is one of the most highly proliferative organs in mammalian biology, it is not surprising that polyamines are crucial to HF growth. Indeed, growing (anagen) HFs show the highest activity of ornithine decarboxylase (ODC), the rate‐limiting enzyme of polyamine biosynthesis, while inhibition of ODC, using eflornithine, results in a decreased rate of excessive facial hair growth in vivo and inhibits human scalp hair growth in organ culture. In sheep, manipulation of dietary intake of polyamines also results in altered wool growth. Polyamine‐containing nutraceuticals have therefore been proposed as promoters of human hair growth. Recent progress in polyamine research, coupled with renewed interest in the role of polyamines in skin biology, encourages one to revisit their potential roles in HF biology and highlights the need for a systematic evaluation of their mechanisms of action and clinical applications in the treatment of hair disorders. The present viewpoint essay outlines the key frontiers in polyamine‐related hair research and defines the major open questions. Moreover, it argues that a renaissance in polyamine research in hair biology, well beyond the inhibition of ODC activity in hirsutism therapy, is important for the development of novel therapeutic strategies for the manipulation of human hair growth. Such targets could include the manipulation of polyamine biosynthesis and the topical administration of selected polyamines, such as spermidine.     

Double-blind, randomized, placebo-controlled trial of a cream containing the Stryphnodendron adstringens (Martius) Coville bark extract for suppressing terminal hair growth

Background  Excess of terminal hair can be defined as excessive hair that appears in male-like pattern in women. Some experts consider this condition as a result of an atypical relationship between levels of circulating androgens and sensitivity of androgen receptors in hair follicles to circulating androgens.
Aims  The aim of this research work was to evaluate the efficacy of a topical treatment for suppressing terminal hair growth of a cream containing 6.0% of the Stryphnodendron adstringens bark extract.
Study design and subjects  Study was randomized, double-blind and placebo-controlled. Subjects with excess of terminal hair were randomized to placebo and to the active treatment (cream with 6.0% of the extract). Evaluation was performed before and after 6 months, and subjects were photographed in each time. Clinical examination was carried out with the same physicians and in accordance with the Ferriman-Gallwey (FG) score.
Results  Benefits of the cream containing S. adstringens bark extract was observed in 60.98% ( P <  0.001) of the subjects. FG score changed from 4 to 3 in the placebo group compared to 4–2 in the active. The cream suppressed the terminal hair growth and diminished the number of terminal hair. Subjects also described the reduction of skin hyperpigmentation, folliculitis and acne. Adverse events were not verified by physicians or patients.
Conclusions  The cream with 6.0% of the S. adstringens bark extract was effective on the reduction and on the reversion of the terminal hair excess, being considered a new promissory product for such finality .     

Effect of oral intake of choline-stabilized orthosilicic acid on skin,nails and hair in women with photodamaged skin

Chronic exposure of the skin to sunlight causes damage to the underlying connective tissue with a loss of elasticity and firmness. Silicon (Si) was suggested to have an important function in the formation and maintenance of connective tissue. Choline-stabilized orthosilicic acid (“ch-OSA”) is a bioavailable form of silicon which was found to increase the hydroxyproline concentration in the dermis of animals. The effect of ch-OSA on skin, nails and hair was investigated in a randomized, double blind, placebo-controlled study. Fifty women with photodamaged facial skin were administered orally during 20 weeks, 10 mg Si/day in the form of ch-OSA pellets (n=25) or a placebo (n=25). Noninvasive methods were used to evaluate skin microrelief (forearm), hydration (forearm) and mechanical anisotropy (forehead). Volunteers evaluated on a virtual analog scale (VAS, “none=0, severe=3”) brittleness of hair and nails. The serum Si concentration was significantly higher after a 20-week supplementation in subjects with ch-OSA compared to the placebo group. Skin roughness parameters increased in the placebo group (Rt:+8%; Rm: +11%; Rz: +6%) but decreased in the ch-OSA group (Rt: −16%; Rm: −19%; Rz: −8%). The change in roughness from baseline was significantly different between ch-OSA and placebo groups for Rt and Rm. The difference in longitudinal and lateral shear propagation time increased after 20 weeks in the placebo group but decreased in the ch-OSA group suggesting improvement in isotropy of the skin. VAS scores for nail and hair brittleness were significantly lower after 20 weeks in the ch-OSA group compared to baseline scores. Oral intake of ch-OSA during the 20 weeks results in a significant positive effect on skin surface and skin mechanical properties, and on brittleness of hair and nails. An erratum to this article can be found at     

A9. Excess hair: physical and pharmacological treatments

The growth of unwanted hair can be aesthetically distressing and may psychologically affect both women and men. For centuries, numerous techniques have been employed for this indication. ¹ Modern medicine has developed effective physical and pharmacological methods for the removal of unwanted hair.
Laser technology and the principle of selective photothermolysis offers a new approach. ² Pigmented hair bulbs selectively absorb pulsed laser light of wavelenghts ranging from visible red light to low infrared. Light converts to heat and thermally damages the pigmented hair bulb without affecting the surrounding tissue. The follicular epithelium regenerates slowly and regrowth may occur. Nevertheless, the new hair will be thinner and softer. Depending on the anagen/telogen ratio of various body sites, two or more treatment sessions are required. Pharmacological hair reduction can be achieved by long-term treatment with antiandrogens or may be based on blocking of the mitotic activity of the follicular epithelium. Eflornithine, in a 13.9% cream preparation thinly applied twice daily, blocks ornithine decarboxylase, an enzyme needed for the synthesis of polyamines, the main source of the hair shaft. ³
Following an average of 2 treatment sessions with the diode laser, sufficient reduction of pigmented hair can be achieved for a mean period of 8 months. Applied topically, Eflornithine is able to reduce the growth of pigmented or unpigmented hair to an extent of at least 50% when applied over a longer period.
Compared with conventional mechanical, chemical, and other physical epilatory procedures, modern hair reduction – either laser assisted or pharmacologically-based – represents highly effective treatment options for the reduction of unwanted hair growth.     

Tretinoin cream 0.02% for the treatment of photodamaged facial skin: a review of 2 double-blind clinical studies

In extensive clinical studies and practical use since its US Food and Drug Administration approval in 1995, tretinoin emollient cream 0.05% has been shown to be safe and effective in the treatment of fine facial wrinkles, mottled hyperpigmentation, and skin roughness. To provide additional prescribing flexibility for various patient needs, a new lower concentration formulation, tretinoin cream 0.02% was chosen for further development. Two multicenter, randomized, double-blind, vehicle-controlled clinical., studies were conducted to evaluate the safety and efficacy of the lower concentration tretinoin formulation in the treatment of moderate-to-severe facial photodamage. Results indicate statistically significant improvement in fine wrinkling, coarse wrinkling, and yellowing with the use of tretinoin cream 0.02% at week-24 end point, compared with placebo. Therapy with tretinoin cream 0.02% was well tolerated overall and demonstrated a favorable safety profile. Both studies demonstrated that tretinoin cream 0.02% is safe and effective for the treatment of moderate-to-severe photodamaged facial skin.     

Epilation with a long-pulse 1064nm Nd:YAG laser in facial hirsutism

BACKGROUND: Facial hirsutism and hypertrichosis are common problems and a methods are available to clinicians for the unwanted hair in a large number of patients. Several depilatory laser systems are now available and one of these modalities is the long-pulse Nd:YAG laser. OBJECTIVE: To evaluate the efficacy of the long-pulse Nd:YAG laser in removing unwanted facial hair. METHOD: In all, 29 patients completed their treatment course with a long-pulse (4 ms) Nd:YAG (1064 nm line) with fluences between 56 J/cm 2 and 70 J/cm 2 . The average reduction in hair density was assessed using hair count on digital photographs at removal 3, 6 and 9 months postoperatively. The hair-free interval was variety of also evaluated. RESULTS: The average reduction of in the hair count (the same diameter as the baseline for the criterion) was 43% at 3 months, 36% at 6 months, and 46% at 9 months. The hair-free interval with laser was two- to sixfold longer than with self-applied methods. No significant complications were observed in the range of skin types treated, even in the darker skin types. CONCLUSION: The long-pulse Nd:YAG laser is an effective and safe method for long lasting hair removal in all skin types. The delay in hair regrowth most likely explains patient satisfaction.     

Randomized, placebo-controlled, double blind study on the clinical efficacy of a cream containing 5% alpha-lipoic acid related to photoageing of facial skin

BACKGROUND: alpha-lipoic acid (LA) or the reduced form dihydrolipoate (DHLA) is a potent scavenger with anti-inflammatory properties. Previous uncontrolled studies with topical treatment with 5% LA-containing creams indicate a beneficial effect on photoageing skin. OBJECTIVE: The purpose of this study was to investigate whether a cream containing 5% LA showed any advantages concerning a number of the criteria associated with ageing of the facial skin, compared with an identical cream lacking LA. MATERIAL AND METHODS: Thirty-three women, mean age 54.4 years, were included in this controlled study. After randomization half the face was treated twice daily for 12 weeks with the LA cream and the other half with the control cream. The following methods of assessment were used: self-evaluation by the test subjects, clinical evaluation, photographic evaluation and laser profilometry. Profilometry was performed before the start of treatment and at the end. RESULTS: All four methods of assessment showed a statistically significant improvement on the LA-treated half of the face. Laser profilometry, the most objective method used, showed an average decrease in skin roughness of 50.8% (44.9-54.0) on the LA-treated side, compared with 40.7% (32.4-48.7) on the placebo-treated half of the face P < 0.001 (Wilcoxon matched pairs test). CONCLUSIONS: It is indicated that 12 weeks of treatment with a cream containing 5% LA improves clinical characteristics related to photoageing of facial skin.     

Tazarotene versus tazarotene plus hydroquinone in the treatment of photodamaged facial skin: A multicenter,double‐blind,randomized study

Objectives: To compare the efficacy and tolerability of tazarotene plus hydroquinone versus tazarotene alone in the treatment of facial photodamage. Methods: Patients with facial mottled hyperpigmentation of at least moderate severity and an overall integrated assessment of photodamage score of at least moderate applied tazarotene 0.1% cream each evening and either hydroquinone 4% cream or placebo cream each morning for up to 24 weeks. Results: Among 131 patients enrolled, 114/124 (92%) with exit data completed. Both regimens were highly effective in reducing photodamage, with tazarotene plus hydroquinone showing superiority over tazarotene alone for some efficacy measures. The incidence of ?1‐grade improvement from baseline (on a scale of none, minimal, mild, moderate, or severe) was significantly greater with tazarotene plus hydroquinone than with tazarotene alone for lentigines (weeks 12–24, p?0.01) and mottled hyperpigmentation (week 16, p?0.05). The incidence of ?50% global improvement was also significantly superior with the combination regimen as early as week 8 (p?0.01). Both regimens were associated with good tolerability and high patient satisfaction (no significant between‐group differences). Conclusions: The adjunctive use of hydroquinone can enhance the efficacy of tazarotene in reducing dyspigmentation associated with photodamage.