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Topical Tazarotene Gel, 0.1%, as a Novel Treatment Approach for Atrophic Postacne Scars: A Randomized Active-Controlled Clinical Trial.

ABSTRACT: Importance:Evidence is robust for the effectiveness of microneedle therapy in the management of postacne atrophic scarring. A home-based topical treatment with an efficacy comparable to microneedling would be a useful addition in the armamentarium of acne scar management. Objective:To compare the efficacy of topical tazarotene gel, 0.1%, with microneedling therapy in the management of moderate to severe atrophic acne scars. Design, Setting, and Participants:Prospective, observer-blinded, active-controlled, randomized clinical trial with 6 months of follow-up conducted between June 2, 2017, and February 28, 2018, at a tertiary care hospital in India. Thirty-six patients with grade 2 to 4 facial atrophic postacne scars and without a history of procedural treatment of acne scars within the previous year were recruited. Analyses were conducted using data from the evaluable population. Interventions:Both halves of each participant's face were randomized to receive either microneedling or topical tazarotene therapy. Microneedling was conducted on 1 side of the face with a dermaroller having a needle length of 1.5 mm for a total of 4 sessions during the course of 3 months. Participants were instructed to apply topical tazarotene gel, 0.1%, to the other side of the face once every night during this same period. Main Outcomes and Measures:Patients were followed up at 3 and 6 months by a blinded observer, and improvements in acne scar severity based on Goodman and Baron quantitative and qualitative scores and a subjective independent dermatologist score (range, 0-10, with higher scores indicating better improvement) were assessed. Patient satisfaction was assessed using a patient global assessment score (ranging from 0 for no response to 10 for maximum improvement) at these follow-up visits. Results:There were 36 participants (13 men and 23 women; mean [range] age, 23.4 [18-30] years), and the median (interquartile range [IQR]) duration of acne was 6 (4-8) years. For the 34 participants included in the complete data analyses, the median (IQR) quantitative score for acne scar severity at the 6-month follow-up visit following treatment with either tazarotene (from a baseline of 8.0 [6.0-9.8] to 5.0 [3.0-6.0]) or microneedling (from a baseline of 7.0 [6.0-10.8] to 4.5 [3.0-6.0]) indicated significant improvement (P?

SUBMITTER: Afra TP

PROVIDER: S-EPMC6439800 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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Topical Tazarotene Gel, 0.1%, as a Novel Treatment Approach for Atrophic Postacne Scars: A Randomized Active-Controlled Clinical Trial.

Afra T P TP Razmi T Muhammed M Narang Tarun T Dogra Sunil S Kumar Ashok A

JAMA facial plastic surgery 20190301 2

<h4>Importance</h4>Evidence is robust for the effectiveness of microneedle therapy in the management of postacne atrophic scarring. A home-based topical treatment with an efficacy comparable to microneedling would be a useful addition in the armamentarium of acne scar management.<h4>Objective</h4>To compare the efficacy of topical tazarotene gel, 0.1%, with microneedling therapy in the management of moderate to severe atrophic acne scars.<h4>Design, setting, and participants</h4>Prospective, obs ...[more]

PMID: 30452511

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Project description:BackgroundVery few clinical trials have investigated the effect of topical acne treatment on scarring.ObjectivesOur objective was to evaluate the efficacy of adapalene 0.3%/benzoyl peroxide 2.5% gel (A0.3/BPO2.5) in atrophic acne scar formation in patients with acne.MethodsIn this multicenter, randomized, investigator-blinded, vehicle-controlled study, subjects with moderate or severe facial acne (Investigator's Global Assessment [IGA] score 3 or 4; ≥ 25 inflammatory lesions; ten or more atrophic acne scars) applied A0.3/BPO2.5 or vehicle daily per half face for 24 weeks. Subjects with acne requiring systemic treatment were excluded. Assessments included investigator atrophic acne scar count, Scar Global Assessment (SGA), acne lesion count, IGA, skin roughness and skin texture, subject self-assessment of clinical acne-related scars and satisfaction questionnaire, tolerability, and safety.ResultsIncluded subjects (n = 67) had mainly moderate acne (92.5% IGA 3); mean scores at baseline were approximately 40 acne lesions and 12 scars per half face. By week 24, the change from baseline in total scar count was - 15.5% for A0.3/BPO2.5 versus + 14.4% for vehicle (approximately 30% difference), with a mean of 9.5 scars versus 13.3 per half face, respectively (p < 0.0001). For SGA at week 24, a total of 32.9% with A0.3/BPO2.5 versus 16.4% with vehicle (p < 0.01) were clear/almost clear. Inflammatory acne lesions decreased by 86.7% for A0.3/BPO2.5 versus 57.9% for vehicle (p < 0.0001), and 64.2 versus 19.4% of subjects, respectively, were IGA clear/almost clear (p < 0.0001) at week 24. Treatment-related AEs were reported by 20.9% for A0.3/BPO2.5 versus 9% for vehicle side, most commonly skin irritation (14.9 vs. 6%, respectively).ConclusionsTopical A0.3/BPO2.5 prevented and reduced atrophic scar formation. Scar count increased with vehicle (+ 14.4%) but decreased with A0.3/BPO2.5 (- 15.5%) over 24 weeks.Trial registryClinicalTrials.gov identifier NCT02735421.

Project description:BackgroundCutaneous microcystic lymphatic malformations (CMLMs) are rare conditions in children and adults. They present as clusters of vesicles full of lymph and blood to various extents, inducing maceration, esthetic impairment, pain, and impaired quality of life. The treatment is challenging. Sirolimus is an inhibitor of mammalian target of rapamycin (mTOR) involved in angio-lymphangiogenesis. Topical sirolimus has recently been reported as effective in a few reports of patients with CMLMs. The objective is to compare the efficacy and safety of a 12-week application of 0.1% topical sirolimus versus topical vehicle in CMLMs in children and adults.MethodsThis French blinded multicenter within-person randomized controlled phase 2 trial aims to include 55 patients aged ≥ 6 years who have a primary CMLM. The CMLM will be divided into two equal areas that will be randomly allocated to 0.1% topical sirolimus or topical vehicle applied for 12 weeks. At the end of the 12-week period, the patient/parent will treat the whole area of CMLM with 0.1% topical sirolimus on remaining lesions, for eight more weeks. Patients will be seen at week 20 (treatment will be stopped) and at month 12 to evaluate long-term efficacy. The primary outcome will be improvement of the CMLM in the area treated with topical sirolimus compared to the area treated with topical vehicle by the investigator physician (blinded to the treatment) with the Physician Global Assessment score at week 12. Secondary outcomes will include: assessment of efficacy by independent experts on the basis of standardized photographs; impact on quality of life; efficacy for oozing, bleeding, erythema, and thickness evaluated by the investigators; and global efficacy as well as efficacy for functional and aesthetic impairment evaluated by the patient. Systemic passage of sirolimus will be measured at weeks 6, 12, and 20, and at week 16 for CMLMs ≥ 900 cm2.DiscussionFor patients with CMLMs, topical sirolimus could be a non-invasive and well-tolerated therapeutic option. If the trial demonstrates efficacy and safety of this treatment, this result will lead to a real change in the management of this condition, and 0.1% sirolimus cream would become the first-line treatment.Trial registrationClinicalTrials.gov, NCT03972592. Registered on 3 June 2019. EU Clinical Trials Register EudraCT, 2018-001359-11.

Project description:ImportanceIn addition to the physical deformity, there is often great psychological burden of facial scars for patients. In this study, we use condensed nanofat combined with fat grafts in a novel technique to improve atrophic facial scars by raising both the surface and the bottom of the affected area.ObjectiveTo assess whether the use of condensed nanofat combined with fat grafting can be effective in treating atrophic facial scars from both an aesthetic and a functional perspective.Design, setting, and participantsIn this prospective case series of 20 patients with 25 atrophic facial scars, each scar was treated with condensed nanofat combined with fat grafts at the Sir Run Run Shaw Hospital, Zhejiang University, Hangzhou, Zhejiang, China. Postoperative results were evaluated by the patients themselves and by 3 senior plastic surgeon observers.Main outcomes and measuresMultiple preoperative and postoperative examinations included the use of the Patient and Observer Scar Assessment Scale (POSAS) to evaluate both the functional and aesthetic aspects of the atrophic facial scars. Punch biopsy specimens were stained for the presence of melanin, elastic fibers, and cytokeratin (CK) 14 and CK19. Images were analyzed using ImageJ software, and the data were analyzed by paired sample t test.ResultsTwenty patients (6 men and 14 women; mean age, 38.25 years; age range, 21-62 years) with a total of 25 atrophic facial scars were treated between March 2014 and December 2016. The patients' mean (SD) scar assessment scores were significantly decreased postoperatively in the final examination for color, 6.40 (0.51) vs 2.40 (0.24) (P < .001); stiffness, 7.20 (0.37) vs 3.20 (0.20) (P < .001); thickness, 5.80 (0.73) vs 1.80 (0.37) (P = .001); and irregularity, 5.20 (0.49) vs 2.20 (0.37) (P = .003); and the observers' scores were also significantly decreased for pigmentation, 4.40 (0.51) vs 2.00 (0.32) (P = .004); thickness, 3.00 (0.32) vs 1.80 (0.20) (P = .03); relief, 4.40 (0.51) vs 2.40 (0.24) (P = .003); and pliability, 4.20 (0.37) vs 1.40 (0.24) (P < .001). In the final follow-up examinations, a significantly improved overall POSAS score was found among both patients, 28.80 (1.02) vs 12.20 (0.80) (P < .001), and observers, 18.00 (0.71) vs 9.20 (0.37) (P = .001). Enhancement of Fontana-Masson staining of melanin in the basal cell layer was observed postoperatively, and a significant postoperative change was detected for the mean (SD) values of average optical density from the preoperative measurement, 0.671 (0.083) vs 0.844 (0.110) (P = .01). The sebaceous glands and sweat glands that were not found in the preoperative images were seen postoperatively by immunohistochemical staining with CK14 and CK19.Conclusions and relevanceOur preliminary clinical and pathological results indicate that the use of condensed nanofat combined with fat grafts may be an effective approach to treating atrophic facial scars from both an aesthetic and a functional perspective.Level of evidence4.

Dataset Information

Topical Tazarotene Gel, 0.1%, as a Novel Treatment Approach for Atrophic Postacne Scars: A Randomized Active-Controlled Clinical Trial.

Publications

Topical Tazarotene Gel, 0.1%, as a Novel Treatment Approach for Atrophic Postacne Scars: A Randomized Active-Controlled Clinical Trial.

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