A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial Assessing the Therapeutic Efficacy of Botulinum Toxin in Treating Scleroderma-Associated Raynaud's Phenomenon

2016 ◽  
Vol 41 (9) ◽  
pp. S2
Author(s):  
Ricardo J. Bello ◽  
Carisa M. Cooney ◽  
Eitan Melamed ◽  
Keith E. Follmar ◽  
Fred J. Wigley ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Botulinum Toxin ◽  
Therapeutic Efficacy ◽  
Raynaud’S Phenomenon ◽  
Raynaud's Phenomenon ◽  
Controlled Clinical Trial ◽  
Double Blinded

scholarly journals Botulinum Toxin to Improve Results in Cleft Lip Repair: A Double-Blinded, Randomized, Vehicle-Controlled Clinical Trial

PLoS ONE ◽  
2014 ◽  
Vol 9 (12) ◽  
pp. e115690 ◽  
Author(s):  
Chun-Shin Chang ◽  
Christopher Glenn Wallace ◽  
Yen-Chang Hsiao ◽  
Chee-Jen Chang ◽  
Philip Kuo-Ting Chen
Keyword(s):  
Clinical Trial ◽  
Botulinum Toxin ◽  
Cleft Lip ◽  
Controlled Clinical Trial ◽  
Cleft Lip Repair ◽  
Double Blinded

scholarly journals The minimally important difference and patient acceptable symptom state for the Raynaud's condition score in patients with Raynaud's phenomenon in a large randomised controlled clinical trial

2009 ◽  
Vol 69 (3) ◽  
pp. 588-591 ◽  
Author(s):  
Puja P Khanna ◽  
Paul Maranian ◽  
Jeff Gregory ◽  
Dinesh Khanna
Keyword(s):  
Clinical Trial ◽  
Raynaud’S Phenomenon ◽  
Randomised Clinical Trial ◽  
Change Score ◽  
Raynaud's Phenomenon ◽  
Controlled Clinical Trial ◽  
Minimally Important Difference ◽  
Condition Score ◽  
Patient Acceptable Symptom State ◽  
The Mean

BackgroundThe Raynaud's condition score (RCS) is a validated outcome measure for Raynaud's phenomenon (RP).ObjectiveTo assess the minimally important difference (MID) and patient acceptable symptom state (PASS) for RCS in patients with RP.Subjects and methodsPatients with active RP (n=162) (mean RCS >25 (0–100 visual analogue scale) participated in a placebo-controlled, crossover randomised clinical trial (RCT). Data from the two treatment groups were combined for this analysis. Retrospective and prospective anchors were administered during the RCT. MID groups were defined as the group who reported being somewhat better (anchor #1) and a one-step change from “unbearable” to “very severe”, etc (anchor #2). Patients were considered to have achieved PASS if they rated their Raynaud's condition as “very mild” or “mild” at the last study visit.ResultsThe mean age of participants was 48.9 years and the mean baseline RCS was 46.4 points. The RCS change score for the MID improvement group ranged from −13.9 to −14.3 points and PASS estimate was 34.0 points.ConclusionThe MID and PASS estimates for RCS are 14–15 points for improvement and 34 points, respectively, on a 0–100 scale in a large RCT of patients with active RP. This information can aid in interpreting RCS in future RP trials.

Liraglutide as an Additional Treatment to Insulin in Patients with Type 1 Diabetes Mellitus—A 52-Week Randomized Double-Blinded Placebo-Controlled Clinical Trial

Diabetes ◽  
2018 ◽  
Vol 67 (Supplement 1) ◽  
pp. 3-LB ◽  
Author(s):  
PARESH DANDONA ◽  
HUSAM GHANIM ◽  
NITESH D. KUHADIYA ◽  
TANVI SHAH ◽  
JEANNE M. HEJNA ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Clinical Trial ◽  
Type 1 Diabetes ◽  
Type 1 Diabetes Mellitus ◽  
Additional Treatment ◽  
Controlled Clinical Trial ◽  
Double Blinded

scholarly journals Administration of Apple Polyphenol Supplements for Skin Conditions in Healthy Women: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Nutrients ◽  
2020 ◽  
Vol 12 (4) ◽  
pp. 1071
Author(s):  
Toshihiko Shoji ◽  
Saeko Masumoto ◽  
Nina Moriichi ◽  
Yasuyuki Ohtake ◽  
Tomomasa Kanda
Keyword(s):  
Clinical Trial ◽  
Uv Irradiation ◽  
Skin Pigmentation ◽  
Controlled Clinical Trial ◽  
Continuous Administration ◽  
Double Blind ◽  
Healthy Women ◽  
Dependent Relationship ◽  
Skin Conditions ◽  
Double Blinded

This clinical study was performed to evaluate the effects of continuous apple polyphenol (AP) administration on facial skin conditions and pigmentation induced by ultraviolet (UV) irradiation in healthy women participants. Participants (n = 65, age 20–39 years) were randomized to receive tablets containing AP (300 or 600 mg/day) or placebo in a double-blinded, placebo-controlled clinical trial. Continuous administration of AP for 12 weeks significantly prevented UV irradiation induced skin pigmentation (erythema value, melanin value, L value), although a dose-dependent relationship was not clearly observed. In contrast, no significant differences were detected between the groups with regard to water content and trans-epidermal water loss. Our study demonstrated that APs and their major active compounds, procyanidins, have several health benefits. Here, we report that continuous administration of AP for 12 weeks alleviated UV irradiation induced skin pigmentation, when compared with placebo, in healthy women.

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