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      Drug Design, Development and Therapy (submit here)

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      Preparation and evaluation of a multimodal minoxidil microemulsion versus minoxidil alone in the treatment of androgenic alopecia of mixed etiology: a pilot study

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          Abstract

          Background:

          The variable success of topical minoxidil in the treatment of androgenic alopecia has led to the hypothesis that other pathways could mediate this form of hair loss, including infection and/or microinflammation of the hair follicles. In this study, we prepared a multimodal microemulsion comprising minoxidil (a dihydrotestosterone antagonist), diclofenac (a nonsteroidal anti-inflammatory agent), and tea tree oil (an anti-infective agent). We investigated the stability and physicochemical properties of this formulation, and its therapeutic efficacy compared with a formulation containing minoxidil alone in the treatment of androgenic alopecia.

          Methods:

          We developed a multimodal oil/water (o/w) microemulsion, a formulation containing minoxidil alone, and another containing vehicle. A three-phase diagram was constructed to obtain the optimal concentrations of the selected oil, surfactant, and cosurfactant. Thirty-two men aged 18–30 years were randomized to apply 1 mL of microemulsion containing the multimodal formulation (formulation A, n = 11), minoxidil alone (formulation B, n = 11) or placebo (formulation C, n = 10) twice daily to the affected area for 32 weeks. Efficacy was evaluated by mean hair count, thickness, and weight on the targeted area of the scalp. Global photographs were taken, changes in the area of scalp coverage were assessed by patients and external investigators, and the benefits and safety of the study medications were evaluated. The physical stability of formula A was examined after a shelf storage period of 24 months.

          Results:

          Formulation A achieved a significantly superior response than formulations B and C in terms of mean hair count ( P < 0.001), mean hair weight ( P < 0.001), and mean hair thickness ( P < 0.05). A patient self-assessment questionnaire demonstrated that the multimodal minoxidil formulation significantly ( P < 0.001) slowed hair loss, increased hair growth, and improved appearance, and showed no appreciable side effects, such as itching and/or inflammation of the scalp compared with the minoxidil alone and placebo formulations. These improvements were in agreement with the photographic assessments made by the investigators. Formula A was shown to be an o/w formulation with consistent pH, viscosity, specific gravity, and homogeneity, and was physically stable after 24 months of normal storage.

          Conclusion:

          A multimodal microemulsion comprising minoxidil, diclofenac, and tea tree oil was significantly superior to minoxidil alone and placebo in terms of stability, safety, and efficacy, and achieved an earlier response in the treatment of androgenic alopecia compared with minoxidil alone in this 32-week pilot study.

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          Most cited references30

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          Melaleuca alternifolia (Tea Tree) oil: a review of antimicrobial and other medicinal properties.

          Complementary and alternative medicines such as tea tree (melaleuca) oil have become increasingly popular in recent decades. This essential oil has been used for almost 100 years in Australia but is now available worldwide both as neat oil and as an active component in an array of products. The primary uses of tea tree oil have historically capitalized on the antiseptic and anti-inflammatory actions of the oil. This review summarizes recent developments in our understanding of the antimicrobial and anti-inflammatory activities of the oil and its components, as well as clinical efficacy. Specific mechanisms of antimicrobial and anti-inflammatory action are reviewed, and the toxicity of the oil is briefly discussed.
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            Patterned loss of hair in man; types and incidence.

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              Finasteride in the treatment of men with androgenetic alopecia. Finasteride Male Pattern Hair Loss Study Group.

              Androgenetic alopecia (male pattern hair loss) is caused by androgen-dependent miniaturization of scalp hair follicles, with scalp dihydrotestosterone (DHT) implicated as a contributing cause. Finasteride, an inhibitor of type II 5alpha-reductase, decreases serum and scalp DHT by inhibiting conversion of testosterone to DHT. Our purpose was to determine whether finasteride treatment leads to clinical improvement in men with male pattern hair loss. In two 1-year trials, 1553 men (18 to 41 years of age) with male pattern hair loss received oral finasteride 1 mg/d or placebo, and 1215 men continued in blinded extension studies for a second year. Efficacy was evaluated by scalp hair counts, patient and investigator assessments, and review of photographs by an expert panel. Finasteride treatment improved scalp hair by all evaluation techniques at 1 and 2 years (P < .001 vs placebo, all comparisons). Clinically significant increases in hair count (baseline = 876 hairs), measured in a 1-inch diameter circular area (5.1 cm2) of balding vertex scalp, were observed with finasteride treatment (107 and 138 hairs vs placebo at 1 and 2 years, respectively; P < .001). Treatment with placebo resulted in progressive hair loss. Patients' self-assessment demonstrated that finasteride treatment slowed hair loss, increased hair growth, and improved appearance of hair. These improvements were corroborated by investigator assessments and assessments of photographs. Adverse effects were minimal. In men with male pattern hair loss, finasteride 1 mg/d slowed the progression of hair loss and increased hair growth in clinical trials over 2 years.
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                Author and article information

                Journal
                Drug Des Devel Ther
                Drug Des Devel Ther
                Drug Design, Development and Therapy
                Dove Medical Press
                1177-8881
                2013
                30 May 2013
                : 7
                : 413-423
                Affiliations
                [1 ]Department of Pharmaceutics, College of Pharmacy, Riyadh Colleges of Dentistry and Pharmacy, Riyadh, Kingdom of Saudi Arabia;
                [2 ]Department of Pharmacology and Toxicology, College of Pharmacy, Riyadh Colleges of Dentistry and Pharmacy, Riyadh, Kingdom of Saudi Arabia;
                [3 ]Department of Pharmaceutical Chemistry, College of Pharmacy, Riyadh Colleges of Dentistry and Pharmacy, Riyadh, Kingdom of Saudi Arabia;
                [4 ]Department of Human Biology and Physiology, College of Pharmacy, Riyadh Colleges of Dentistry and Pharmacy, Riyadh, Kingdom of Saudi Arabia
                Author notes
                Correspondence: Farouk M Sakr, Pharmacy and Applied Medical Sciences, Riyadh Colleges of Dentistry and Pharmacy, PO Box 84891, Riyadh 11681, Kingdom of Saudi Arabia, Tel +96 61 9200 0018, Email farouksakr@ 123456riyadh.edu.sa
                Article
                dddt-7-413
                10.2147/DDDT.S43481
                3686323
                23807837
                4f5633c0-bd68-445d-b66f-b40d1a378425
                © 2013 Sakr et al, publisher and licensee Dove Medical Press Ltd.

                This is an Open Access article which permits unrestricted noncommercial use, provided the original work is properly cited.

                History
                : 29 May 2013
                Categories
                Original Research

                Pharmacology & Pharmaceutical medicine
                androgenic alopecia,diclofenac,microemulsion,minoxidil,nonsteroidal anti-inflammatory agents,tea tree oil

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