Dataset Information

Evaluating a Topical Adjunctive Post Submental ATX-101 (Deoxycholic Acid) Injections for Improved Recovery: A Single-Center, Double-Blind, Randomized Controlled Pilot Study.

ABSTRACT:

Background

Optimizing postprocedural recovery and outcomes for patients is the aim for all physicians. TransFORM Body Treatment with TriHex Technology (TFB) is a topical product that aids in the elimination of fat particles created during procedures and the reduction of associated inflammation, thus speeding up postprocedure recovery time.

Objectives

Evaluation of postprocedural symptoms, signs, and healing following submental deoxycholic acid (DCA) injections in combination with TFB.

Methods

Participants received 2 treatments of submental DCA injections. Posttreatment 1, every participant received TFB to apply twice daily to the submental area. Follow-up visits included weeks 1, 2, and 4. After week 4, participants discontinued TFB for 30 days before the second treatment. At the second treatment visit, participants were randomized to receive either TFB or a bland moisturizer to apply twice daily with the same follow-up visits as posttreatment 1. Induration measurements, submental fullness grading, and standardized photography were captured at every visit. At all follow-up visits and before treatment 2, investigator assessments and participant assessments were completed.

Results

Posttreatment 2, investigator assessments of edema and induration decreased in participants using TFB at weeks 1 and 2 compared with the bland moisturizer. Induration measurements objectively showed a statistically significant reduction at week 2 (posttreatment 2) in participants using TFB compared with the bland moisturizer. Furthermore, participants reported less tenderness and soreness in the TFB group over the bland moisturizer.

Conclusions

Investigator assessments, participant query, and objective induration analyses have demonstrated that the use of TFB post DCA injections may reduce induration, edema, and discomfort associated with this procedure.

Level of evidence 2

SUBMITTER: Shridharani SM

PROVIDER: S-EPMC8353883 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:BACKGROUND:Bacterial keratitis is a serious ocular infectious disease that can lead to severe visual disability. Risk factors for bacterial corneal infection include contact lens wear, ocular surface disease, corneal trauma and previous ocular or eyelid surgery. Topical antibiotics constitute the mainstay of treatment in cases of bacterial keratitis where as the use of topical corticosteroids remains controversial. Topical corticosteroids are usually used to control inflammation using the smallest amount of the drug. Their use requires optimal timing, concomitant antibiotics and careful follow up. OBJECTIVES:The objective of the review was to assess the clinical effectiveness and adverse effects of corticosteroids as adjunctive therapy for bacterial keratitis. SEARCH STRATEGY:We searched CENTRAL, MEDLINE, EMBASE, and LILACS up to 15 January 2007. We also searched the Science Citation Index to identify additional studies that had cited the included trial, an online database of ongoing trials (www.clinicaltrials.gov), reference lists of included trials, earlier reviews and the American Academy of Ophthalmology guidelines. We also contacted experts to identify any unpublished and ongoing randomized trials. SELECTION CRITERIA:We included randomized controlled trials evaluating adjunctive therapy with topical corticosteroids in people with bacterial keratitis. DATA COLLECTION AND ANALYSIS:Two review authors independently screened all the retrieved articles. Methodological quality of the one included trial was assessed using forms developed using pre-specified criteria by at least two review authors. We planned to extract data on outcomes using forms developed for the purpose. We planned to report risk ratios for dichotomous outcomes and mean differences for continuous outcomes. MAIN RESULTS:A single trial was eligible for inclusion in the review. Participants in the trial were randomized using a random numbers table. Allocation concealment was not attempted. Masking of participants, and care-providers was also not attempted. Outcome assessment was conducted independently by two physicians. Neither was masked to the treatment allocation. The trial reported the healing rate of epithelial defects and improvement in visual acuity. AUTHORS' CONCLUSIONS:There are no good quality randomized trials evaluating the effects of adjunct use of topical corticosteroids in bacterial keratitis. The only randomized trial we identified in the literature suffered from major methodological inadequacies.

Project description:BACKGROUND:Intravitreal injection (IVI) is a very common vitreoretinal procedure, and multiple injections are often required per patient. This systematic review was conducted to evaluate the effectiveness of various local anesthetic techniques in reducing pain during injection. METHODS:A systematic review was conducted based on searches of Cochrane, LILACS, PubMed, Scopus, Web of Science, and the gray literature (Google Scholar). The end search date was February 19, 2016, across all databases. We classified pain by converting visual analog scale (VAS) scores (0-100 mm) into Jensen's classification levels: 0-4, no pain; 5-44, mild pain; 45-74, moderate pain; and 75-100, severe pain. An intervention was considered clinically significant when pain score change was >12 mm on a 100-mm scale. RESULTS:Eight studies out of 23 met the eligibility criteria. The total number of patients was 847. Most studies (5/8 [62.5%]) were at unclear risk of bias because of unclear randomization, thus providing only moderate evidence to this review. The anesthetic techniques included eye drops with proparacaine, tetracaine or cocaine, a lidocaine pledget or gel, and subconjunctival injection of 2% lidocaine or 0.75% levobupivacaine. No study comprised all of the techniques. Pain was mild (VAS scores, 5-44 mm) regardless of anesthetic technique. A clinically significant intervention (pain score change >12 mm) was found for only one study comparing proparacaine drops, lidocaine gel, and subconjunctival lidocaine; in that study, a subconjunctival injection of 2% lidocaine provided the greatest pain reduction. A meta-analysis was not possible due to study heterogeneity. CONCLUSIONS:Patient pain during IVI under topical anesthesia is mild regardless of anesthetic technique. A subconjunctival injection of 2% lidocaine could be an option for highly sensitive patients. However, with moderate level of evidence, no single anesthetic technique could be defined as the best option for IVI.