A new topical biotechnological phytocomplex for truncal mild-moderate acne restores skin microbiota balance.

BACKGROUND: The disruption of the microbial community or dysbiosis alters the functional composition, metabolic activity, and local distribution of the microbiota leading the development of acne. The aim of this study is to evaluate the effect of a lotion containing a biotechnological phytocomplex, niacinamide, and succinic acid in the bacterial diversity of subjects with truncal mild-moderate acne and its clinical benefits due to microbiota changes. MATERIALS AND METHODS: Open, clinical study in 43 subjects with truncal mild-moderate acne treated with a lotion for 8 weeks. Bacterial diversity was analyzed by 16S rRNA gene sequencing of skin samples. Clinical effects were evaluated through IGA acne severity scale, biometric measurements, and safety. RESULTS: After 56 days of product's use, an increase in richness alpha diversity was found (p = 0.005), with a decrease in Cutibacterium acnes relative abundance (66.43% vs. 58.11%, p = 0.009). The clinical results showed a decrease in IGA score (27.59% decrease; p = 0.001), the inflammatory lesions (52.12% decrease, p = 0.006) and erythema (18.33% decrease, p = 0.007), and desquamation index (63.83% decrease, p = 0.02). The responder analysis of the IGA score showed that 60.47% of patients improved by at least one point at day 56. The product was well tolerated along the study. CONCLUSION: The use of the lotion on acneic skin was effective on rebalancing the microbiota, inhibiting biofilm formation and other virulence factors, reducing erythema and desquamation, and improving acne's severity.

Efficacy and safety of a new medicated nail hydrolacquer in the treatment of adults with toenail onychomycosis: A randomised clinical trial.

BACKGROUND: A new water-soluble formulation with ciclopirox has shown a higher penetration than other ciclopirox nail lacquers currently marketed, thus providing a higher concentration of ciclopirox into the nail. OBJECTIVE: To evaluate the efficacy and safety of a new ciclopirox nail hydrolacquer compared with its vehicle and an active comparator (hydroxypropyl chitosan-based 80 mg/g ciclopirox nail lacquer) for the treatment of toenail fungal infection. METHODS: Phase III, multicenter, randomised, double-blind, clinical trial in patients with distal mild to moderate toenail onychomycosis due to dermatophyte fungi. Patients were randomised to apply topically a ciclopirox nail hydrolacquer, its vehicle or a reference product once daily for 48 weeks with a follow-up period of 4 weeks up to week 52. RESULTS: A total of 381 patients were included. No statistically significant differences were observed between patient groups in the proportion of subjects achieving a complete cure. At week 52, a higher percentage of patients in the ciclopirox nail hydrolacquer group achieved a mycological cure (negative for culture and DTS/KOH test, with results: 32.0% ciclopirox nail hydrolacquer, 23.2% vehicle and 27% reference product, respectively), and similar results were found for improvement (mycological cure and reduction of diseased nail ≥20%, with results: 27.2% ciclopirox nail hydrolacquer, 21.6% vehicle and 20.6% reference product, respectively). Regarding mycological results, only ciclopirox nail hydrolacquer demonstrated significant statistical superiority versus vehicle negativizing dermatophyte culture (p = .039) with no recurrences, relapses or re-infections in a four-week follow-up patients with complete cure. The safety profile was comparable to the vehicle and reference product and consistent with the previously reported. CONCLUSIONS: A new water-soluble formulation for a ciclopirox nail lacquer showed similar efficacy to the reference product to eradicate toenail onychomycosis and superiority in the mycological cure defined by negative culture, thus preventing reinfections and recurrences. Efficacy and safety data demonstrate the positive benefit-risk profile of this new topical antifungal preparation. [Correction added on 13 April 2023, after first online publication: The results and conclusions in the Abstract contained incorrect information and were revised in this version.].

Trends in contraception use in Spanish adolescents and young adults (15 to 24 years) between 2002 and 2008.

OBJECTIVE: To assess changes in the use of contraceptive methods, and induced abortion rates, in Spanish adolescents and young adults aged 15 to 24 years, between 2002 and 2008. STUDY DESIGN: Representative samples of Spanish men and women aged 15 to 24 years were surveyed in 2002 (N = 1826) and 2008 (N = 2000). RESULTS: The rate of use of contraceptive methods increased from 61% in men and 60% in women in 2002 to 80% and 75%, respectively, in 2008. The most commonly used method was the condom (51% in 2002 and 71% in 2008), followed by the contraceptive pill (18% in 2002 and 18% in 2008). None of the adolescents and young adults surveyed used natural methods or the diaphragm, or had undergone sterilisation. The induced abortion rate increased from 9.28 to 13.48 per 1000 women in the group aged between 15 and 19 years, and from 14.37 to 21.05 per 1000 women in the group aged 20 to 24 years. CONCLUSION: Despite an increase in the use of effective birth control methods, the rates of abortion rose during the study period, which may indicate that compliance with the use of condoms is inadequate. There is an urgent need to develop educational campaigns or to design specific policies addressing contraception-related issues for young people.

Contraceptive practices of women requesting induced abortion in Spain: a cross-sectional multicentre study.

OBJECTIVES: To collect information on (i) contraceptive methods used immediately before unwanted pregnancy, and (ii) planned contraception following induced abortion among Spanish residents. METHODS: Eight centres officially accredited to perform abortions participated in a cross-sectional study. The study population included 2475 women requesting induced abortion between 1 January and 31 March 2007. RESULTS: Contraceptive methods used before unwanted pregnancy were condoms in 40% of the cases, combined hormonal contraception in 14%, and other methods (mainly natural methods and withdrawal) in 10%. Thirty-six percent of women did not use any contraceptive method. Failure of the method due to incorrect use was reported by 77% of those using condoms and by 84% of those using hormonal contraception. Only 23% of women planned to use a contraceptive method after abortion. Almost half of the women were immigrants. CONCLUSION: Despite the use of effective contraceptive methods, the majority of women requesting induced abortion in Spain became pregnant during the use of these methods. These data reflect a lack of compliance. More education programmes are needed to improve compliance rates. The long-acting reversible contraceptive methods could constitute an appropriate approach.

Development and validation of the SEC-QOL questionnaire in women using contraceptive methods.

OBJECTIVES: Develop and validate a Spanish society of contraception quality-of-life (SEC-QOL) questionnaire to assess the impact of contraceptive methods on the health-related quality of life (HRQOL) of women. METHODS: SEC-QOL was developed following a standardized procedure including review of the literature, interviews with contraception users, and the administration of a pilot questionnaire to 187 women. SEC-QOL consists of 19 items and includes five dimensions. To validate the questionnaire, a multicenter, observational, prospective study was conducted in Spain. The following three study groups were defined: group A (n = 129) comprised women using effective contraceptive methods; group B (n = 251), comprised women about to start using an effective method; and group C (n = 73) comprised women using no or poorly effective contraception. All women attended baseline and final visits (4 ± 1 months). Participants completed the SEC-QOL, psychological well-being index, EuroQol five-dimensional questionnaire, and perceived health state questionnaires. RESULTS: At baseline, women from group A had a better HRQOL in all SEC-QOL dimensions, except for breast symptoms. Heavier menstrual bleeding, more androgenic and breast symptoms, menstrual pain, and not using hormonal contraceptive methods were associated with lower HRQOL. SEC-QOL scores showed moderate correlations to psychological well-being index and slightly lower correlation to EuroQol five-dimensional questionnaire scores. At follow-up, HRQOL had improved in all groups; most markedly in group B, which obtained an average effect size of 0.59. The minimum important difference was established as a 3.4-point change in the global SEC-QOL score. SEC-QOL obtained a Cronbach's α of 0.88 and an intraclass correlation coefficient of 0.82. CONCLUSIONS: SEC-QOL is a valid, reliable, and sensitive to change questionnaire for use in daily clinical practice and future research projects on contraception.

Prevalence of premenstrual syndrome and premenstrual dysphoric disorder in a representative cohort of Spanish women of fertile age.

OBJECTIVE: To assess the prevalence of premenstrual symptoms, premenstrual syndrome and premenstrual dysphoric disorder in a cohort of women of fertile age representative of the general Spanish population. STUDY DESIGN: During the period between November 27th and December 22nd, 2008, a cross-sectional nationwide survey was conducted among a cohort of Spanish women aged between 15 and 49 years. Participants were personally interviewed at home and completed the premenstrual symptoms screening tool. RESULTS: Of the 2108 participants, 1554 women (73.7%) complained of some of the premenstrual symptoms during the last 12 menstrual cycles. A total of 1415 (91%) women presented isolated symptoms and 139 (8.9%) a moderate/severe premenstrual syndrome. Twenty-four (1.1%) women fulfilled criteria for a diagnosis of premenstrual dysphoric disorder. CONCLUSION: The prevalence of premenstrual symptoms (73.7%) and premenstrual dysphoric disorder (1.1%) in Spanish women aged between 15 and 49 years is similar to that reported in other Western countries. Only women with moderate or severe premenstrual syndrome or premenstrual dysphoric disorder, however, had daily life activities significantly impaired by premenstrual symptoms.

Trends in the use of contraceptive methods and voluntary interruption of pregnancy in the Spanish population during 1997-2007.

BACKGROUND: This study was designed to acquire information about the use of contraceptive methods in order to reduce the number of elective abortions. STUDY DESIGN: Since 1997, representative samples of Spanish women of childbearing potential (15-49 years) have been surveyed by the Daphne Team every 2 years to gather data of contraceptive methods used. RESULTS: During the study period, 1997 to 2007, the overall use of contraceptive methods increased from 49.1% to 79.9%. The most commonly used method was the condom (an increase from 21% to 38.8%), followed by the pill (an increase from 14.2% to 20.3%). Female sterilization and IUDs decreased slightly and were used by less than 5% of women in 2007. The elective abortion rate increased from 5.52 to 11.49 per 1000 women. CONCLUSIONS: The factors responsible for the increased rate of elective abortion need further investigation.