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更新于：2026-08-19
Difa - Cooper SpA
更新于：2026-08-19
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ISRCTN58661770
Skin anti-aging effect of a melatonin-based in&out strategy in comparison with topical treatment alone: a randomized, assessor-blinded, prospective trial with VISIA evaluation
ISRCTN18369035
Palatability of two different formulations of urea for the treatment of hyponatremia: a double-blind, cross-over study
ISRCTN10404684
Efficacy and tolerability of a topical formulation based on growth factors, caffeine and taurine in male subjects with androgenetic alopecia who are candidates for pharmacological treatments (topical minoxidil or oral finasteride): A prospective, randomized, assessor-blinded, parallel group study.
100 项与 Difa - Cooper SpA 相关的临床结果
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2023-12-01Clinical nutrition ESPEN
Palatability of two different formulations of urea for the treatment of hyponatremia: A double-blind, randomized, cross-over study
Article
作者: Milani, Massimo ; Colombo, Francesca
BACKGROUND AND AIMS:
Hyponatremia (HN) is the most common disorder of electrolytes encountered in clinical practice. Considering that HN is associated with high morbidity and mortality, it is important to identify treatments for these patients. The therapeutic approaches for HN depend on the severity and the character of the pathology (acute vs. chronic). Among intervention strategies, oral urea represents an effective, safe, and well-tolerated therapeutic approach in the management of chronic hyponatremia. Oral ureal is commonly prepared as a galenic formulation that is usually associated with distaste problems. A double-blind, randomized, cross-over clinical trial was conducted to evaluate and compare the palatability of two different urea formulations: a commercial urea formulation and a galenic one (trial registered on www.isrctn.com, number: ISRCTN18369035).
MATERIALS AND METHODS:
Thirty-six healthy subjects (18 female and 18 male, median age 55 years) were enrolled in the study and randomized to consume 7 g of formulation A (commercial formulation) or formulation B (galenic formulation) twice a day away from meals, solubilizing the products in 125 mL of water (T0). After three days of a wash-out, the formulations were crossed-over and consumed twice a day away from meals (T4). After the consumption of products, both in the morning and the evening, participants completed a specific questionnaire to evaluate the products' palatability.
RESULTS:
The commercial formulation was globally more appreciated than the galenic one, in terms of smell, taste, and aftertaste. The commercial formulation was better accepted as a potential treatment in 44 % of subjects compared to 14 % of subjects for galenic formulation.
CONCLUSIONS:
The clinical trial confirmed the better palatability of the commercial oral urea formulation, containing citrus flavor, which therefore represents a therapeutic strategy that could improve adherence to the therapy in chronic patients with hyponatremia.
2018-09-01Dermatology and therapy4区 · 医学
Treatment of Grade II and III Actinic Keratosis Lesions with a Film-Forming Medical Device Containing Sunscreen/Piroxicam 0.8% and a Retinoic Acid/Glycolic Gel: A Pilot Trial
4区 · 医学
ArticleOA
作者: Puviani, Mario ; Milani, Massimo
INTRODUCTION:
Lesion and field-targeted treatments of actinic keratosis (AK) are commonly indicated for grade I and II type lesions. Grade III lesions are in general more difficult to treat. A film-forming medical device containing piroxicam 0.8% and sunscreen (SPF 50+) (PS) has been shown to be effective in the treatment of grade I and II AK lesions. Topical and oral retinoids have been utilized in AK and non-melanoma skin cancers. Topical glycolic acid promotes keratolysis and stimulates collagen synthesis for repair and skin rejuvenation and could be useful in AK treatment strategies. A gel containing retinoid acid (0.02%) and glycolic acid (4%) (RC) is commercially available. The objective of the study was to evaluate the efficacy and local tolerability of a combined treatment approach with PS and RC in subjects with multiple grade II and III AK lesions.
METHODS:
Twenty-two subjects (16 males and 6 females; mean age 68 years) with more than five AK lesions were enrolled after obtaining their informed consent in a 3-month trial. PS cream was applied twice daily every day and RC gel was applied twice daily for 2 consecutive days every week. The primary endpoint was the evolution of the AK mean number from baseline to the end of the trial. Secondary endpoints were the thickness of the target lesion (expressed in mm3) and the erythema score (hemoglobin content), evaluated using a standardized computer-based image acquisition analysis system (Anthera 3D).
RESULTS:
At baseline, the mean (SD) lesion number was 7.7 (3) for grade II and 1.4 (1) for grade III AK. At the end of the study, a significant (P = 0.001) reduction was observed for both grade II (- 81%; from 7.7 to 1.5) and grade III (- 22%) lesions. Six grade III lesions out of 31 (20%), presented at baseline, completely disappeared at month 3. For grade III lesions, a significant mean thickness reduction of 51% was observed at month 3. The erythema score (all lesions) was reduced by 70%. Four patients out of 22 (18%) were completely free of AK lesions at month 3. No severe side effects were reported.
CONCLUSION:
In this exploratory trial, a combined treatment with a cream containing piroxicam and sunscreen and a retinoic/glycolic gel was associated with a substantial reduction of both grade II and III AK lesions with good local tolerability.
FUNDING:
Cantabria Labs Difa Cooper.
Clinical, cosmetic and investigational dermatology4区 · 医学
<p>Skin protective effects of an antipollution, antioxidant serum containing <em>Deschampsia antartica</em> extract, ferulic acid and vitamin C: a controlled single-blind, prospective trial in women living in urbanized, high air pollution area</p>
4区 · 医学
ArticleOA
作者: Celleno, Leonardo ; Milani, Massimo ; Hashtroody, Bita ; Piacentini, Marco
Introduction: Air pollution causes skin damage and favors skin aging processes such as dark spots and wrinkles, through oxidative stress. Pollutant substances accelerate skin aging through a specific activation of intracellular receptors called AhR (aryl-hydrocarbon receptors). Deschampsia antartica aqueous extract (DAE) has shown to counteract the pollutant-induced AhR activation. Ferulic acid (FA) and vitamin C (VC) are potent antioxidant substances. A serum containing DAE/FA/VC has been recently developed. So far, no clinical data are available regarding the protective actions of this serum against the detrimental effects of air pollution on the skin. Objective: We conducted a prospective, single-blind, 28-day study to assess efficacy and protective effects against air pollution skin damage of a new serum containing Deschampsia antartica extract. Materials and methods: Twenty, photo type I-III, women (mean age 42 years) with at least three dark spots on the face, living in a homogenous urbanized, high pollution area (Rome) were evaluated. The objectives of the study were to evaluate the effects of treatment on skin barrier function, assessed by transepidermal water loss (TEWL) measurement (Tewameter), the effect on dark spots, evaluated by means of colorimetry (Colorimeter CL 400), and the effect on squalene peroxide (SQOOH)/squalene (SQ) skin ratio assessed with face swabs. Results: The trial was conducted between November 20 and December 19, 2018. In comparison with baseline, the product induced a significant improvement of skin hydration (-19% of TEWL), a significant improvement of dark spots (+7%) and a significant improvement of SQOOH/SQ ratio (-16%). The product was evaluated very well by >90% of the treated subjects regarding cosmetic acceptability. Discussion: A serum containing DAE/FA/VC has shown to improve skin barrier function, to reduce dark spots and to counteract the skin oxidative stress in women living in high pollution urban area.
2026-05-29
2025-12-02
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