Original Paper Dermatology 2015;230:308–313 DOI: 10.1159/000371416
Received: July 16, 2014 Accepted after revision: December 8, 2014 Published online: March 4, 2015
Bimatoprost versus Mometasone Furoate in the Treatment of Scalp Alopecia Areata: A Pilot Study Hesham Zaher Heba I. Gawdat Rehab A. Hegazy Marwa Hassan Department of Dermatology, Faculty of Medicine, Cairo University, Cairo, Egypt
Abstract Background: Alopecia areata (AA) is an immune-mediated disease that targets anagen hair follicles. Despite various therapeutic options, there is no cure for AA. Prostaglandin analogues have been recognized as being capable of inducing hypertrichosis. Objective: To compare the efficacy and safety of bimatoprost to those of corticosteroid in the treatment of scalp AA. Methods: Thirty adult patients with patchy AA (S1) were included. Two AA patches were randomly assigned to treatment either by mometasone furoate 0.1% cream once daily (area A) or bimatoprost 0.03% solution twice daily (area B) for 3 months. Patients were assessed using the Severity of Alopecia Tool (SALT) scoring system for hair re-growth. Results: All responding AA patches showed significant reduction in their SALT score after therapy. Area B demonstrated significantly better results regarding rapidity of response in weeks, percentage of hair re-growth and side effects compared to area A. Conclusion: Bimatoprost solution represents a therapeutic option for scalp AA. © 2015 S. Karger AG, Basel
© 2015 S. Karger AG, Basel 1018–8665/15/2304–0308$39.50/0 E-Mail [email protected] www.karger.com/drm
Introduction
Alopecia areata (AA) is a complex genetic, immunemediated disease that targets anagen hair follicles [1]. This relatively common autoimmune disease affects both males and females without either age or race predilection [2]. AA classically presents as well-demarcated skin-colored patches of hair loss. It usually affects the scalp, but any hair-bearing area can be involved [3]. Unfortunately, there is currently no cure for this chronic disease, and despite the presence of a wide variety of therapeutic options, none is universally proven to induce and/or sustain remission [4]. Among the various lines of therapy for AA, topical and intralesional corticosteroids are appreciated as a standard therapy [5]. The recognition of a prostaglandin (PG) analogue (latanoprost) as a drug capable of inducing hypertrichosis involving eyelashes, adjacent adnexal hair and vellus hair of the skin [6, 7] attracted the attention of many researchers to the potential use of PG and prostamide analogues in the treatment of hair loss, especially AA. Accordingly, several studies have been conducted to explore the potentials of this therapeutic modality. However, they yielded conflicting results and were mainly focused on AA of the eyelashes [8–12]. This debate triggered the conduction of Heba I. Gawdat, MD Department of Dermatology, Faculty of Medicine, Cairo University Street No. 104, Building 59, Maadi Gardens Cairo 11431 (Egypt) E-Mail heba.gawdat @ yahoo.com
Downloaded by: University of New Orleans 137.30.242.61 - 5/8/2015 12:02:30 PM
Key Words Alopecia areata · Bimatoprost · Corticosteroids · Efficacy · Side effects
Patients and Methods The Dermatology Research Ethical Committee, Faculty of Medicine, Cairo University approved this prospective randomized intra-patient comparative single-blinded clinical trial. Informed written consent was obtained from all patients before conducting the study. Thirty adult patients (18 males, 12 females) aged 19–48 years with at least two non-adjacent scalp AA patches were enrolled in this study. All recruited patients had a Severity of Alopecia Tool (SALT) score of S1 (≤25% hair loss) [13], with either stationary or progressive course. Patients with alopecia totalis, alopecia universalis, ophiasis and/or those who had received treatment for AA within 3 months prior to the study were excluded. Patients with reported spontaneous hair re-growth were strictly exempted. Patients with associated systemic and/or other dermatological diseases were not included. At baseline, all patients were subjected to detailed history taking and clinical examination. The diagnosis was based on a combination of clinical and dermoscopic evaluation criteria. Treatment Protocol Two non-adjacent scalp AA patches in each patient were randomly assigned to treatment by either topical corticosteroid cream (area A) or bimatoprost solution (area B). Each patient was instructed to apply bimatoprost 0.03% solution (Lumigan, Allergan, 3 ml) to one AA patch twice daily by using a cotton-tipped applicator and to apply topical corticosteroid cream (Elcon, mometasone furoate cream 0.1%, Schering-Plough, 20 g) once daily on the other patch for a period of 3 months. Each patient was instructed not to mix the two medications and to wear a head cover (plastic wrapping) for occlusion (for 2 h) to promote absorption. Patient Assessment Patients were assessed on a weekly basis for a period of 3 months. All assessments were performed by three blinded physicians through comparing serial photographs of patients with their baseline ones using a Nikon COOLPIX S26600 14-megapixel digital camera. The average SALT score was calculated at the end of the treatment period (3 months) and the average percentage of hair re-growth using the SALT scoring system for hair re-growth [13] was documented, where A0 = no change or further loss, A1 = 1–24% re-growth, A2 = 25–49% re-growth, A3 = 50–74% regrowth, A4 = 75–99% re-growth and A5 = 100% re-growth. The time when hair re-growth first occurred (initial response) was also documented and side effects were meticulously reported. Patient Satisfaction All patients were instructed to report their opinion (satisfied or unsatisfied) of the used medication regarding efficacy, rapidity of response and the occurrence of side effects.
Bimatoprost and Alopecia Areata
Follow-Up All patients were followed up for a period of an additional 3 months after cessation of therapy to evaluate the sustainability of the response and to report the incidence of recurrence of AA if any. Statistical Methods Data were statistically described in terms of mean ± standard deviation (SD), median and range, or frequencies (number of cases) and percentages when appropriate. Comparison of numerical variables between the study groups was done using the Wilcoxon signed-rank test for paired (matched) samples. For comparing categorical data, the McNemar and χ2 test were performed. The exact test was used instead if the expected frequency was
Received: July 16, 2014 Accepted after revision: December 8, 2014 Published online: March 4, 2015
Bimatoprost versus Mometasone Furoate in the Treatment of Scalp Alopecia Areata: A Pilot Study Hesham Zaher Heba I. Gawdat Rehab A. Hegazy Marwa Hassan Department of Dermatology, Faculty of Medicine, Cairo University, Cairo, Egypt
Abstract Background: Alopecia areata (AA) is an immune-mediated disease that targets anagen hair follicles. Despite various therapeutic options, there is no cure for AA. Prostaglandin analogues have been recognized as being capable of inducing hypertrichosis. Objective: To compare the efficacy and safety of bimatoprost to those of corticosteroid in the treatment of scalp AA. Methods: Thirty adult patients with patchy AA (S1) were included. Two AA patches were randomly assigned to treatment either by mometasone furoate 0.1% cream once daily (area A) or bimatoprost 0.03% solution twice daily (area B) for 3 months. Patients were assessed using the Severity of Alopecia Tool (SALT) scoring system for hair re-growth. Results: All responding AA patches showed significant reduction in their SALT score after therapy. Area B demonstrated significantly better results regarding rapidity of response in weeks, percentage of hair re-growth and side effects compared to area A. Conclusion: Bimatoprost solution represents a therapeutic option for scalp AA. © 2015 S. Karger AG, Basel
© 2015 S. Karger AG, Basel 1018–8665/15/2304–0308$39.50/0 E-Mail [email protected] www.karger.com/drm
Introduction
Alopecia areata (AA) is a complex genetic, immunemediated disease that targets anagen hair follicles [1]. This relatively common autoimmune disease affects both males and females without either age or race predilection [2]. AA classically presents as well-demarcated skin-colored patches of hair loss. It usually affects the scalp, but any hair-bearing area can be involved [3]. Unfortunately, there is currently no cure for this chronic disease, and despite the presence of a wide variety of therapeutic options, none is universally proven to induce and/or sustain remission [4]. Among the various lines of therapy for AA, topical and intralesional corticosteroids are appreciated as a standard therapy [5]. The recognition of a prostaglandin (PG) analogue (latanoprost) as a drug capable of inducing hypertrichosis involving eyelashes, adjacent adnexal hair and vellus hair of the skin [6, 7] attracted the attention of many researchers to the potential use of PG and prostamide analogues in the treatment of hair loss, especially AA. Accordingly, several studies have been conducted to explore the potentials of this therapeutic modality. However, they yielded conflicting results and were mainly focused on AA of the eyelashes [8–12]. This debate triggered the conduction of Heba I. Gawdat, MD Department of Dermatology, Faculty of Medicine, Cairo University Street No. 104, Building 59, Maadi Gardens Cairo 11431 (Egypt) E-Mail heba.gawdat @ yahoo.com
Downloaded by: University of New Orleans 137.30.242.61 - 5/8/2015 12:02:30 PM
Key Words Alopecia areata · Bimatoprost · Corticosteroids · Efficacy · Side effects
Patients and Methods The Dermatology Research Ethical Committee, Faculty of Medicine, Cairo University approved this prospective randomized intra-patient comparative single-blinded clinical trial. Informed written consent was obtained from all patients before conducting the study. Thirty adult patients (18 males, 12 females) aged 19–48 years with at least two non-adjacent scalp AA patches were enrolled in this study. All recruited patients had a Severity of Alopecia Tool (SALT) score of S1 (≤25% hair loss) [13], with either stationary or progressive course. Patients with alopecia totalis, alopecia universalis, ophiasis and/or those who had received treatment for AA within 3 months prior to the study were excluded. Patients with reported spontaneous hair re-growth were strictly exempted. Patients with associated systemic and/or other dermatological diseases were not included. At baseline, all patients were subjected to detailed history taking and clinical examination. The diagnosis was based on a combination of clinical and dermoscopic evaluation criteria. Treatment Protocol Two non-adjacent scalp AA patches in each patient were randomly assigned to treatment by either topical corticosteroid cream (area A) or bimatoprost solution (area B). Each patient was instructed to apply bimatoprost 0.03% solution (Lumigan, Allergan, 3 ml) to one AA patch twice daily by using a cotton-tipped applicator and to apply topical corticosteroid cream (Elcon, mometasone furoate cream 0.1%, Schering-Plough, 20 g) once daily on the other patch for a period of 3 months. Each patient was instructed not to mix the two medications and to wear a head cover (plastic wrapping) for occlusion (for 2 h) to promote absorption. Patient Assessment Patients were assessed on a weekly basis for a period of 3 months. All assessments were performed by three blinded physicians through comparing serial photographs of patients with their baseline ones using a Nikon COOLPIX S26600 14-megapixel digital camera. The average SALT score was calculated at the end of the treatment period (3 months) and the average percentage of hair re-growth using the SALT scoring system for hair re-growth [13] was documented, where A0 = no change or further loss, A1 = 1–24% re-growth, A2 = 25–49% re-growth, A3 = 50–74% regrowth, A4 = 75–99% re-growth and A5 = 100% re-growth. The time when hair re-growth first occurred (initial response) was also documented and side effects were meticulously reported. Patient Satisfaction All patients were instructed to report their opinion (satisfied or unsatisfied) of the used medication regarding efficacy, rapidity of response and the occurrence of side effects.
Bimatoprost and Alopecia Areata
Follow-Up All patients were followed up for a period of an additional 3 months after cessation of therapy to evaluate the sustainability of the response and to report the incidence of recurrence of AA if any. Statistical Methods Data were statistically described in terms of mean ± standard deviation (SD), median and range, or frequencies (number of cases) and percentages when appropriate. Comparison of numerical variables between the study groups was done using the Wilcoxon signed-rank test for paired (matched) samples. For comparing categorical data, the McNemar and χ2 test were performed. The exact test was used instead if the expected frequency was
