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JAMA Dermatology Jun 2024Inconsistent reporting of outcomes in clinical trials of rosacea is impeding and likely preventing accurate data pooling and meta-analyses. There is a need for...
IMPORTANCE
Inconsistent reporting of outcomes in clinical trials of rosacea is impeding and likely preventing accurate data pooling and meta-analyses. There is a need for standardization of outcomes assessed during intervention trials of rosacea.
OBJECTIVE
To develop a rosacea core outcome set (COS) based on key domains that are globally relevant and applicable to all demographic groups to be used as a minimum list of outcomes for reporting by rosacea clinical trials, and when appropriate, in clinical practice.
EVIDENCE REVIEW
A systematic literature review of rosacea clinical trials was conducted. Discrete outcomes were extracted and augmented through discussions and focus groups with key stakeholders. The initial list of 192 outcomes was refined to identify 50 unique outcomes that were rated through the Delphi process Round 1 by 88 panelists (63 physicians from 17 countries and 25 patients with rosacea in the US) on 9-point Likert scale. Based on feedback, an additional 11 outcomes were added in Round 2. Outcomes deemed to be critical for inclusion (rated 7-9 by ≥70% of both groups) were discussed in consensus meetings. The outcomes deemed to be most important for inclusion by at least 85% of the participants were incorporated into the final core domain set.
FINDINGS
The Delphi process and consensus-building meetings identified a final core set of 8 domains for rosacea clinical trials: ocular signs and symptoms; skin signs of disease; skin symptoms; overall severity; patient satisfaction; quality of life; degree of improvement; and presence and severity of treatment-related adverse events. Recommendations were also made for application in the clinical setting.
CONCLUSIONS AND RELEVANCE
This core domain set for rosacea research is now available; its adoption by researchers may improve the usefulness of future trials of rosacea therapies by enabling meta-analyses and other comparisons across studies. This core domain set may also be useful in clinical practice.
Topics: Rosacea; Humans; Clinical Trials as Topic; Consensus; Delphi Technique; Outcome Assessment, Health Care; Treatment Outcome
PubMed: 38656294
DOI: 10.1001/jamadermatol.2024.0636 -
Experimental Dermatology Apr 2024The close interaction between skin and clothing has become an attractive cornerstone for the development of therapeutic textiles able to alleviate skin disorders, namely... (Review)
Review
The close interaction between skin and clothing has become an attractive cornerstone for the development of therapeutic textiles able to alleviate skin disorders, namely those correlated to microbiota dysregulation. Skin microbiota imbalance is known in several skin diseases, including atopic dermatitis (AD), psoriasis, seborrheic dermatitis, rosacea, acne and hidradenitis suppurative (HS). Such microbiota dysregulation is usually correlated with inflammation, discomfort and pruritus. Although conventional treatments, that is, the administration of steroids and antibiotics, have shown some efficacy in treating and alleviating these symptoms, there are still disadvantages that need to be overcome. These include their long-term usage with side effects negatively impacting resident microbiota members, antibiotic resistance and the elevated rate of recurrence. Remarkably, therapeutic textiles as a non-pharmacological measure have emerged as a promising strategy to treat, alleviate the symptoms and control the severity of many skin diseases. This systematic review showcases for the first time the effects of therapeutic textiles on patients with skin dysbiosis, focusing on efficacy, safety, adverse effects and antimicrobial, antioxidant and anti-inflammatory properties. The main inclusion criteria were clinical trials performed in patients with skin dysbiosis who received treatment involving the use of therapeutic textiles. Although there are promising outcomes regarding clinical parameters, safety and adverse effects, there is still a lack of information about the impact of therapeutic textiles on the skin microbiota of such patients. Intensive investigation and corroboration with clinical trials are needed to strengthen, define and drive the real benefit and the ideal biomedical application of therapeutic textiles.
Topics: Humans; Dysbiosis; Skin; Textiles; Dermatitis, Atopic; Pruritus; Allergens
PubMed: 38628046
DOI: 10.1111/exd.15081 -
Cureus Mar 2024A large portion of the world's population is affected by acne vulgaris (AV), with many of these individuals being adolescents. The underlying mechanism of AV is... (Review)
Review
A large portion of the world's population is affected by acne vulgaris (AV), with many of these individuals being adolescents. The underlying mechanism of AV is hyperkeratinization and infection of the pilosebaceous follicle secondary to excessive stimulation of sebaceous glands by androgens. Metformin is a biguanide medication primarily used in efforts to lower patients' sugar levels in the management of type 2 diabetes. It has been proven to reduce levels of circulating androgens in patients with insulin resistance, indicating its potential for treating AV. A search strategy was developed and performed using the databases Ovid Medical Literature Analysis and Retrieval System Online (MEDLINE), Excerpta Medica database (EMBASE), Cumulative Index to Nursing and Allied Health Literature (CINAHL), Cochrane Controlled Register of Trials (CENTRAL), and Web of Science. The keywords "metformin" and "acne" were searched, along with related Medical Subject Headings (MeSH) and other subject headings. Studies that met the inclusion criteria were controlled trials, published after 2010, and in the English language. Participants with and without comorbidities such as polycystic ovary syndrome (PCOS) were considered. Two independent reviewers screened studies based on predefined criteria and extracted data from each study, which were quantitatively combined. A total of 15 studies were included in this systematic review. Across the 15 studies, there were 1,046 participants, with 13 studies looking exclusively at women with PCOS. Of the remaining two studies, one examined males with altered metabolic profiles, while the other included men and women with moderate AV. Notable risks of bias included studies that did not exclusively state the blindness of the study. Of the studies that were examined, 13 showed that metformin reduces AV, with seven studies showing statistical significance. Acne vulgaris is an inflammatory condition that has plagued patients for years due to the limited treatment options available. The hyperglycemic medication metformin, used in the management of type 2 diabetes, is being explored as a novel therapeutic that can possibly be repurposed for the treatment of AV. The use of metformin in AV is hypothesized to disrupt the proposed linkage between insulin resistance and AV proliferation. This proposed research could offer physicians a new option for the treatment of AV as well as render an alternative AV treatment for patients.
PubMed: 38623111
DOI: 10.7759/cureus.56246 -
Critical Reviews in Therapeutic Drug... 2024Cosmeceuticals have gained great importance and are among the top-selling products used for skin care. Because of changing lifestyles, climate, and increasing pollution,...
Cosmeceuticals have gained great importance and are among the top-selling products used for skin care. Because of changing lifestyles, climate, and increasing pollution, cosmeceuticals are utilized by every individual, thereby making cosmeceuticals a fruitful field for research and the economy. Cosmeceuticals provide incredibly pleasing aesthetic results by fusing the qualities of both cosmetics and medicinal substances. Cosmeceuticals are primarily utilized to improve the appearance of skin by making it smoother, moisturized, and wrinkle-free, in addition to treating dermatological conditions, including photoaging, burns, dandruff, acne, eczema, and erythema. Nanocosmeceuticals are cosmetic products that combine therapeutic effects utilizing nanotechnology, allowing for more precise and effective target-specific delivery of active ingredients, and improving bioavailability.
Topics: Humans; Cosmeceuticals; Skin Care; Skin; Acne Vulgaris; Nanotechnology
PubMed: 38608133
DOI: 10.1615/CritRevTherDrugCarrierSyst.v41.i5.20 -
Cureus Mar 2024The treatment of acne vulgaris poses a significant challenge due to its chronic nature and potential influence on patients' quality of life. Isotretinoin, a systemic... (Review)
Review
The treatment of acne vulgaris poses a significant challenge due to its chronic nature and potential influence on patients' quality of life. Isotretinoin, a systemic retinoid, has emerged as one of the most efficient treatment options for chronic, severe acne. However, the use of isotretinoin is associated with a range of side effects that require careful consideration. This review article provides a comprehensive overview of the side effects linked to isotretinoin treatment for acne vulgaris. Through an analysis of existing literature and clinical studies, we discuss the various adverse reactions, their incidence, management strategies, and the influence of these side effects on patients' quality of life.
PubMed: 38601403
DOI: 10.7759/cureus.55946 -
Journal of Drugs in Dermatology : JDD Apr 2024Bakuchiol is a topical cosmeceutical marketed as a retinoid alternative. Human clinical trial data on bakuchiol’s efficacy for the treatment of dermatologic... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Bakuchiol is a topical cosmeceutical marketed as a retinoid alternative. Human clinical trial data on bakuchiol’s efficacy for the treatment of dermatologic conditions has not been thoroughly evaluated.
OBJECTIVE
To review human clinical trials using topical formulations containing bakuchiol in the treatment of facial skin disorders.
MATERIALS AND METHODS
A comprehensive electronic search of Cochrane Library, PubMed, EMBASE, and Web of Science was conducted on August 28, 2022, using the search terms “bakuchiol” and “UP256.” Study characteristics, measured outcomes, significant results, and stated limitations were extracted. Results: Fifteen human clinical trials were analyzed. Dermatologic conditions treated included aging, acne, and post-inflammatory hyperpigmentation. Twelve trials were unblinded, open-label trials without a control group. Ten trials used a combination therapy containing bakuchiol. Four trials did not specify the dose or concentration of bakuchiol in treatment regimens. The heterogeneity of treatments, study designs, and measured outcomes makes meta-analysis unfeasible. Conclusion: Trials lack methodologic rigor, which introduces a high risk of bias in reported outcomes. The use of combination topical formulations containing bakuchiol limits the comparison of bakuchiol’s efficacy with retinoids. Continued research with an improved trial design is needed.J Drugs Dermatol. 2024;23(4): doi:10.36849/JDD.7763.
Topics: Humans; Acne Vulgaris; Phenols; Retinoids
PubMed: 38564402
DOI: 10.36849/JDD.7763 -
Journal of Drugs in Dermatology : JDD Apr 2024Multiple treatment options exist for the management of moderate-to-severe acne. However, the comparative effectiveness (efficacy/safety) of moderate-to-severe acne... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Multiple treatment options exist for the management of moderate-to-severe acne. However, the comparative effectiveness (efficacy/safety) of moderate-to-severe acne treatments has not been systematically examined.
METHODS
A systematic literature review (SLR) was conducted to identify randomized controlled trials of ≥4 weeks of treatment (topical, oral, physical, or combinations) for moderate-to-severe facial acne in patients aged ≥9 years. Efficacy outcomes included: percentage of patients achieving ≥2-grade reduction from baseline and “clear” or “almost clear” for global severity score (treatment success); absolute change in inflammatory (ILs reduction); and noninflammatory lesion counts (NILs reduction). A random-effects network meta-analysis (NMA) was conducted for the efficacy outcomes. Treatments were ranked with posterior rank plots and surface under cumulative ranking values. Results: Eighty-five studies were included in the SLR/NMA. Topical triple-agent fixed-dose combination (FDC) gel (clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1%) and combinations of double-agent fixed-dose topical treatments with oral antibiotics (TOA3) consistently ranked in the top 3 treatments. Topical triple-agent FDC gel was numerically superior to TOA3 for treatment success (log-odds ratios: 1.84 [95% credible interval (CrI) 1.36 to 2.29]) and 1.69 (95% CrI: 1.01 to 2.32) vs placebo/vehicle). TOA3 was numerically superior to topical triple-agent FDC gel for reduction of ILs (mean difference: -8.21 [-10.33 to -6.13]) and -10.40 [-13.44 to -7.14] vs placebo/vehicle) and NILs (mean difference: -13.41 [-16.69 to -10.32] and -17.74 [-22.56 to -12.85] vs placebo/vehicle).
CONCLUSIONS
Based on this SLR/NMA, topical triple-agent FDC gel was the most efficacious and safe treatment for moderate-to-severe acne. J Drugs Dermatol. 2024;23(4): doi:10.36849/JDD.8148.
Topics: Humans; Dermatologic Agents; Benzoyl Peroxide; Acne Vulgaris; Network Meta-Analysis; Drug Combinations; Adapalene, Benzoyl Peroxide Drug Combination; Treatment Outcome; Gels
PubMed: 38564399
DOI: 10.36849/JDD.8148 -
Journal of Cutaneous Medicine and... Mar 2024
PubMed: 38554064
DOI: 10.1177/12034754241239252 -
Archives of Dermatological Research Mar 2024The relationship between acne vulgaris and oxidative stress biomarkers lacks a clear consensus. This study aimed to explore the potential correlation between acne... (Meta-Analysis)
Meta-Analysis
The relationship between acne vulgaris and oxidative stress biomarkers lacks a clear consensus. This study aimed to explore the potential correlation between acne vulgaris and circulating oxidative stress biomarkers (superoxide dismutase [SOD], malondialdehyde [MDA], and total antioxidant capacity [TAC]). We searched the PubMed, Embase, and Cochrane Library databases for articles published before June 26, 2023. The literature search combined free words and the medical subject headings terms related to acne vulgaris, SOD, MDA, and TAC. Data were analyzed using Stata 15 software. Additionally, we conducted a subgroup analysis stratified by the severity of acne vulgaris. A total of 14 trials involving 1191 participants were included. Overall results revealed that acne vulgaris was associated with MDA concentrations (SMD = 1.73; 95% CI 1.05, 2.4; P < 0.001). Subgroup analyses indicated that the severity of acne vulgaris was correlated with levels of circulating biomarkers of oxidative stress. TAC concentrations were significantly lower in patients with moderate acne vulgaris compared to controls (SMD = - 1.37; 95% CI = - 2.15, - 0.58, P = 0.001). SOD concentrations were significantly lower (SMD = - 2.92; 95% CI = - 5.39, - 0.46, P = 0.02) and MDA concentrations were significantly higher (SMD = 2.26; 95% CI = 0.95, 3.57, P = 0.001) in patients with severe acne vulgaris compared to controls. Our results implied that oxidative stress may exist in acne vulgaris. Furthermore, the severity of acne vulgaris was also correlated with oxidative stress.
Topics: Humans; Acne Vulgaris; Antioxidants; Biomarkers; Oxidative Stress; Superoxide Dismutase
PubMed: 38489064
DOI: 10.1007/s00403-024-02840-5 -
The Australasian Journal of Dermatology Jun 2024
Topics: Humans; Hidradenitis Suppurativa; Delayed Diagnosis; Greece; Male; Female; Adult; Cohort Studies; Middle Aged
PubMed: 38480921
DOI: 10.1111/ajd.14247