The efficacy of synthetic pseudo-ceramide for dry and rough lips.

OBJECTIVE: Lips can easily become dry and rough, one reason being the characteristics of their ceramide (CER) profile. Lips have lower levels of total ceramides, higher percentages of CER[NS] and CER[AS], and lower percentages of CER[NP] and CER[NH] than skin in other regions of the body. The purpose of this study was to clarify the effects of synthetic pseudo-ceramide (pCer; Cetyl-PG hydroxyethyl palmitamide) to improve the dryness and roughness of the lips of healthy subjects in a formulation that exclude an occlusive effect. METHODS: Thirty-one Japanese female subjects with normal skin (age range 21-37 years; mean 28.6) were enrolled in this study. A four-week continuous use test was conducted using samples with or without 0.5% or 2.0% pCer. The degree of lip roughness was scored, and values of capacitance, transepidermal water loss (TEWL) and lip surface elasticity were measured. Endogenous CER profiles and absorption levels of pCer in the stratum corneum (SC) were analysed in tape-stripped skin specimens. RESULTS: Treatment with the pCer-2.0% sample significantly improved the visual roughness score after 2 and 4 weeks compared to 0 weeks and compared to the Blank. Moreover, an improvement in TEWL was observed after 4 weeks of treatment with the pCer-2.0% sample. CER[NP] showed a significant increase in pCer-2.0% treated lips after 4 weeks compared to the Blank. Both pCer-0.5% and pCer-2.0% were significantly absorbed after 2 weeks compared with the Blank. CONCLUSION: The effect of the synthetic pseudo-ceramide pCer to improve the roughness of lips was shown excluding the effect of occlusiveness derived from the formulation for the first time. Since the improvement of TEWL and absorption of pCer was observed, we concluded that pCer was first absorbed in rough lip areas, improved the ceramide profile and consequently restored the barrier function.

OBJECTIF: Les lèvres peuvent facilement devenir sèches et rugueuses, l'une des raisons étant les caractéristiques de leur profil de céramide (CER). Les lèvres présentent des taux plus faibles de céramides totaux, des pourcentages plus élevés de CER[NS] et de CER[AS] et des pourcentages plus faibles de CER[NP] et CER[NH] que la peau des autres régions de l'organisme. L'objectif de cette étude visait à clarifier les effets du pseudo-céramide synthétique (pCer; cétyl-PG hydroxyéthyl palmitamide) pour améliorer la sécheresse et la rugosité des lèvres de sujets en bonne santé avec une formulation excluant un effet occlusif. MÉTHODES: Trente et un sujets de sexe féminin japonais ayant une peau normale (tranche d'âge: 21 à 37 ans; moyenne: 28,6 ans) ont été inclus dans cette étude. Une analyse d'utilisation continue de quatre semaines a été effectuée en employant des échantillons avec ou sans pCer à 0,5 % ou 2,0 %. Le degré de rugosité des lèvres a été noté et les valeurs de capacitance, de perte d'eau transépidermique (transepidermal water loss, TEWL) et d'élasticité de la surface des lèvres ont été mesurées. Les profils CER endogènes et les niveaux d'absorption de pCer de la couche cornée (stratum corneum, SC) ont été analysés dans des échantillons cutanés fixés par bande adhésive. RÉSULTATS: Le traitement avec l'échantillon pCer-2,0% a amélioré de façon significative le score de rugosité visuelle après 2 et 4 semaines par rapport à 0 semaine et par rapport au groupe témoin. En outre, une amélioration de la TEWL a été observée après 4 semaines de traitement avec l'échantillon pCer-2,0%. Après 4 semaines, le CER[NP] a aumenté de manière significative dans les lèvres traitées avec pCer-2,0% par rapport au groupe témoin. Le pCer-0,5 % et le pCer-2,0% ont tous deux été absorbés de manière significative après 2 semaines par rapport au groupe témoin. CONCLUSION: L'effet du pseudo-céramide synthétique pCer pour améliorer la rugosité des lèvres a été démontré, excluant l'effet de l'occlusion dérivé de la formulation pour la première fois. Puisque l'amélioration de la TEWL et l'absorption du pCer ont été observées, nous avons conclu que le pCer était d'abord absorbé dans les zones rugueuses des lèvres, améliorait le profil du céramide et, par conséquent, rétablissait la fonction barrière.

The efficacy of a highly occlusive formulation for dry lips.

OBJECTIVE: Since skin on the lips has a lower water content in the stratum corneum (SC) and a higher transepidermal water loss (TEWL) value than skin on the cheek, the lips are usually very dry and rough areas. Therefore, a lip balm approach to increase occlusivity of the lips is generally used to reduce water loss. Although there have been reports of an improvement effect on lip roughness by specific care agents, differences in the effects due to the occlusivity of a formulation without a specific care agent have not been reported. The purpose of this study was to clarify the improvement effect on dryness and roughness of the lips by a highly occlusive formulation consisting of a combination of common oil and wax, not by a specific care agent. METHODS: Twenty Japanese female subjects with normal skin (age range 20-39 years; mean 28.1) were enrolled in this study. A 4-week continuous use test was conducted using samples with low and high occlusivity. The degree of lip roughness and wrinkles was scored, the hollow index was assessed using ANTERA 3D images, and values of capacitance and TEWL were measured. RESULTS: The hollow index was significantly correlated with both the appearance roughness score and the wrinkle score. The sample with high occlusivity showed significant improvement in the appearance roughness score, wrinkle score, the hollow index and capacitance of the SC. In a comparison between the groups of samples with different occlusive properties, a significant improvement effect in rough appearance was seen in subjects using the highly occlusive formulation. CONCLUSION: The hollow index assessed by ANTERA 3D imaging allowed the objective evaluation of the improvement in appearance. In the case of continuous use of the highly occlusive formulation, an improvement of capacitance in the SC, which is most correlated with lip roughness, was obtained after 2 and 4 weeks. These results demonstrate for the first time that a highly occlusive formulation is effective in improving the roughness of the lips, and this effect is due to the difference in the occlusive property not by a specific care agent.

OBJECTIF: La peau qui recouvre les lèvres ayant une plus faible teneur en eau dans la couche cornée (CC) et une valeur de perte d'eau transépidermique (PETE) plus élevée que la peau des joues, les lèvres sont généralement des zones très sèches et rugueuses. Par conséquent, l'utilisation d'un baume à lèvres pour augmenter l'occlusivité des lèvres est généralement l'approche adoptée pour réduire la perte d'eau. Même s'il y a eu des rapports d'un effet d'amélioration de la rugosité des lèvres grâce à des agents de soin spécifiques, aucune différence par rapport aux effets dus aux propriétés occlusives d'une formule ne contenant pas un agent de soin spécifique n'a été rapportée. Le but de cette étude était de clarifier l'effet d'amélioration de la sécheresse et de la rugosité des lèvres d'une formule hautement occlusive composée d'une association d'huile et de cire courantes, et non pas d'un agent de soin spécifique. MÉTHODES: Vingt sujets de sexe féminin japonais ayant une peau normale (tranche d'âge : 20 à 39 ans ; moyenne : 28,1) ont été inclus dans cette étude. Un test d'utilisation continue pendant 4 semaines a été mené en utilisant des échantillons ayant des propriétés occlusives faibles et élevées. Le degré de rugosité et de ridules des lèvres a été noté, l'indice de creux a été évalué à l'aide d'images 3D ANTERA, et les valeurs de capacitance et de PETE ont été mesurées. RÉSULTATS: L'indice de creux était significativement corrélé avec le score de l'aspect de rugosité et le score de ridules. L'échantillon comportant des propriétés occlusives élevées a démontré une amélioration significative du score de l'aspect de rugosité, du score de ridules, de l'indice de creux et de la capacitance de la CC. Dans une comparaison entre les groupes d'échantillons comportant différentes propriétés occlusives, une amélioration significative de l'effet sur l'aspect rugueux a été observée chez les sujets utilisant la formule aux propriétés occlusives élevées. CONCLUSION: L'indice de creux évalué par l'imagerie 3D ANTERA a permis d'effectuer une évaluation objective de l'amélioration de l'aspect. Dans le cas d'une utilisation continue de la formule aux propriétés occlusives élevées, une amélioration de la capacitance de la CC, qui était le plus corrélée avec la rugosité des lèvres, a été atteinte au bout de 2 et 4 semaines. Ces résultats montrent pour la première fois qu'une formule aux propriétés occlusives élevées est efficace dans l'amélioration de la rugosité des lèvres, et cet effet est dû à la différence dans les propriétés occlusives et non pas à un agent de soin spécifique.

High frequency ultrasound imaging as a "potential" way of evaluation modality in side effects of lip augmentation - case report.

Lip augmentation is a popular procedure performed by esthetic medicine doctors, however, it is associated with a significant number of side effects. High frequency ultrasound imaging helps with diagnosis of side effects.The patient was 43-year-old healthy female, 8 months after lip augmentation.The examination showed a variety of delayed side effects of lip augemntation. Ultrasound imaging revealed an increased echogenicity of lip soft tissue, too deep filler injection, occlusion of the inferior labial artery.

Defective regression models for cure rate modeling with interval-censored data.

Regression models in survival analysis are most commonly applied for right-censored survival data. In some situations, the time to the event is not exactly observed, although it is known that the event occurred between two observed times. In practice, the moment of observation is frequently taken as the event occurrence time, and the interval-censored mechanism is ignored. We present a cure rate defective model for interval-censored event-time data. The defective distribution is characterized by a density function whose integration assumes a value less than one when the parameter domain differs from the usual domain. We use the Gompertz and inverse Gaussian defective distributions to model data containing cured elements and estimate parameters using the maximum likelihood estimation procedure. We evaluate the performance of the proposed models using Monte Carlo simulation studies. Practical relevance of the models is illustrated by applying datasets on ovarian cancer recurrence and oral lesions in children after liver transplantation, both of which were derived from studies performed at A.C. Camargo Cancer Center in São Paulo, Brazil.

Dermoscopy and reflectance confocal microscopy for monitoring the treatment of actinic cheilitis with ingenol mebutate gel: Report of three cases.

Actinic cheilitis (AC) can precede the development of squamous cell carcinoma (SCC) of the lip, a location with higher risk of invasiveness and metastasis. Herein, we reported the use of ingenol mebutate (IngMeb) 0.015% gel on three consecutive days to treat three patients suffering from AC. All the three patients achieved complete clearance of AC with rapid clinical effect, favorable safety profile, good patient's compliance related to short time of applications, and few local skin reactions. So IngMeb is an attractive new therapy for AC. Moreover, the present case report adds further evidence to the usefulness of dermoscopy and Reflectance confocal microscopy (RCM) in the assessment and monitoring of treatment outcome.

Randomized, Evaluator-Blinded Study Comparing Safety and Effect of Two Hyaluronic Acid Gels for Lips Enhancement.

BACKGROUND: Hyaluronic acid (HA) fillers may differ in terms of gel characteristics and ease of use and it is of interest whether this might affect safety and duration of effect. OBJECTIVE: To compare the long-term safety and effect of 2 HA fillers produced by 2 different technologies for lip enhancement. MATERIALS AND METHODS: Subjects with very thin to moderately thick lips were randomized and treated with HA-RK (N = 31) or HA-JV (N = 29) to improve lip fullness by ≥ 1 grade on a 5-point scale, using a maximum of 3 mL of product. RESULTS: A smaller volume of HA-RK compared with HA-JV was required to improve lip fullness by ≥ 1 grade (mean: 1.54 mL vs 1.94 mL, p < .001). Despite the smaller volume, lip fullness and global aesthetic improvement were comparably sustained in both groups. At 6 months, 60.0% versus 57.7% of subjects (HA-RK vs HA-JV) had improved lip fullness. At 12 months, 71.4% versus 76.0% had aesthetic improvement (blinded evaluations) and 85.7% versus 86.2% felt more attractive. Both products were well tolerated. CONCLUSION: Both products achieved durable improvement in lip fullness and aesthetic appearance. A significantly smaller amount of HA-RK was required compared with HA-JV to achieve optimal treatment effect.

Removal of Polyacrylamide Gel (Aquamid®) from the Lip as a Solution for Late-Onset Complications: Our 8-Year Experience.

BACKGROUND: The polyacrylamide hydrogel Aquamid® has been used as a permanent filler to enhance facial soft tissue volume and correct wrinkles since 2001. Various long-term studies have proved the safety of the product. Nonetheless, if complications such as migration occur, they can be difficult to treat. METHODS: Eleven patients suffering from late-onset complications after taking Aquamid® injections in the lips underwent product removal and subsequent labial reconstruction between 2009 and 2017. The reconstruction was performed using a modified bikini reduction technique combined, in eight cases, with immediate autologous fat grafting. RESULTS: In all the patients, general fibrosis and a diffused distribution of the product within all three layers of the lips resulted in the need for labial reconstruction. Migration, as far as in the mucosa and perioral skin, accounted for macroscopically visible yellowish accumulations. In ten out of eleven cases, an individually modified bikini reduction technique, with or without any combination of autologous fat grafting, led to an esthetically satisfying result. One patient developed a severe upper lip necrosis. CONCLUSION: Contradictory to several previous studies attesting to the lack of migration after Aquamid® application to the lips, capsule formation around the product is impaired, allowing for migration even years after the injection. Product aspiration is not possible in these cases, thus necessitating complex lip reconstruction. Bikini reduction and fat grafting are valuable tools for labial reconstruction. Product residuals within the mucosa have to be accepted. Special care has to be taken while treating smokers. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Safety and Effectiveness of VYC-15L, a Hyaluronic Acid Filler for Lip and Perioral Enhancement: One-Year Results From a Randomized, Controlled Study.

BACKGROUND: VYC-15L (Juvéderm Volbella XC) is a nonanimal crosslinked hyaluronic acid (HA) gel with lidocaine. OBJECTIVE: To evaluate the safety and effectiveness of VYC-15L for lip and perioral enhancement versus a nonanimal stabilized HA with lidocaine (Restylane-L; NASHA). METHODS: This prospective multicenter study randomized 225 adults with minimal, mild, or moderate lip fullness on the validated 5-point Allergan Lip Fullness Scale (LFS) to treatment with VYC-15L or NASHA; optional touch-up was administered 30 days later. Subjects were followed for 1 year. The primary effectiveness end point was noninferiority of VYC-15L versus NASHA by mean change in LFS score from baseline to Month 3. RESULTS: The primary end point was met. At Month 3, LFS responder rates were 80.3% for VYC-15L versus 70.8% for NASHA. LFS responder rates exceeded 60% through 1 year with VYC-15L. Perioral lines severity improved for 65.4% and 66.2% of VYC-15L subjects at Month 3 and Year 1, respectively. At Month 3, 96.1% and 88.2% of subjects reported improvement in FACE-Q Satisfaction With Lips and Satisfaction With Lip Lines, respectively. Severe injection site responses were reported less frequently with VYC-15L than NASHA. CONCLUSION: VYC-15L was safe and effective for lip and perioral enhancement, with treatment effects lasting through 1 year.

Clinical Assessment of Immediate and Long-Term Effects of a Two-Step Topical Hyaluronic Acid Lip Treatment.

Key features of lip aging include loss of volume, color, and definition as well as increases in lines/wrinkles and uneven skin texture. A single-center, open-label clinical study was conducted to assess the efficacy and tolerability of a novel, topical two-step lip treatment (HA5 LS) in female subjects presenting with mild to moderate lip dryness and mild to severe lip condition. Subjects were instructed to apply HA5 LS at least three times a day to ensure coverage 8 hours a day for four weeks. Clinical assessments for efficacy and tolerability were conducted at baseline, baseline post-application, week 2, and week 4. Standardized digital photography, subject self-assessment questionnaires, and instrumentation measurements for skin hydration (corneometer) and lip plumpness (digital caliper) were also conducted. Thirty-six female subjects aged 22-40 years enrolled in the study. HA5 LS provided instant and long term effects, achieving significant improvements in all clinical grading parameters including lip texture, color, definition/contour, scaling, cupping, lines/wrinkles, lip plumpness, and overall lip condition from baseline post-application to week 4 (all P less than equal to .001; Wilcoxon signed-rank test). Instrumentation measurements for hydration and digital caliper at weeks 2 and 4 were also significant (all P less than equal to .032; paired t-test). HA5 LS was also well-tolerated and highly-rated by subjects throughout the study duration. Results from this study suggest that HA5 LS addresses the key features of lip aging, providing both instant and long-term benefits.

J Drugs Dermatol. 2017;16(4):366-371.

ANGIOEDEMA AFTER ANGIOTENSIN-CONVERTING ENZYME INHIBITORS.

Angiotensin-converting enzyme inhibitors (ACEI) are one of the most frequently used drugs in the therapy of cardiovascular diseases. Beneficial therapeutic effects may be accompanied by different adverse reactions including angioedema. Recently published data suggest that ACEI-induced angioedema can be life-threatening without emergent intervention, for example due to the respiratory arrest. Monitoring this adverse Jreaction may be especially important for elderly patients who probably receive many different medicines and supplements and thus might be particularly at risk of adverse drug reactions. In the paper we describe two cases of ACEI-induced angioedema in older patients.

Lip Injection Techniques Using Small-Particle Hyaluronic Acid Dermal Filler.

The shape and fullness of the lips have a significant role in facial aesthetics and outward appearance. The corrective needs of a patient can range from a subtle enhancement to a complete recontouring including correction of perioral rhytides. A comprehensive understanding of the lower face anatomical features and injection site techniques are foundational information for injectors. Likewise, the choice of filler material contributes to the success of the injection techniques used, and facilitates a safe, effective, and natural appearing outcome. The small-particle HA 20 mg/mL with lidocaine 0.3% (SP-HAL, Restylane® Silk; Galderma Laboratories, Fort Worth, Texas) is indicated for submucosal implantation for lip augmentation and dermal implantation for correction of perioral rhytides. Due to its rheological properties and smaller particle size, SP-HAL is a well-suited filler for the enhancement and correction of lip shape and volume, as well as for the correction of very fine perioral rhytides. This work is a combined overview of techniques found in the current literature and recommendations provided by contributing authors.

J Drugs Dermatol. 2016;15(9):1076-1082.

Application of Local Injection of Botulinum Toxin A in Cosmetic Patients with Congenital Drooping Mouth Corner.

OBJECTIVE: This study aimed to investigate the clinical application and efficacy of local injection of botulinum toxin A (BTX-A) at the depressor anguli oris in patients with congenital drooping mouth corner. METHODS: From September 2013 to March 2015, 36 cosmetic patients received local injections of botulinum toxin A at the depressor anguli oris, with 1-3 injection sites in the moving region of the depressor anguli oris on each side. At each injection site, 2-4 U of BTX-A was injected, and the total dose for any unilateral treatment did not exceed 8 U. The change in the degree of drooping of the mouth corner before and after the injection was analyzed using statistical methods. The clinical efficacy, preservation time, and adverse reactions were observed. RESULTS: The degree of drooping of the mouth corners of the cosmetic patients before the treatment was compared with that at 1 month after using a paired t test, and the difference was statistically significant, with P < 0.01. The treatment results were satisfactory, and the effect was preserved for 6-9 months. None of the 36 cosmetic patients had any complications of bruising, infection, dysfunction in opening and closing the mouth, smile asymmetry, drooling, or dysarthria after the injection. CONCLUSIONS: The local injection of BTX-A at the depressor anguli oris can effectively lift a drooping mouth corner, thereby improving the depressed, stern, and aged appearance of the face. The performance of this treatment is simple, safe, and easy to perform in clinical applications. LEVEL OF EVIDENCE V: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Ingenol mebutate gel treatment for actinic cheilitis: report of four cases.

Actinic cheilitis (AC) are premalignant lesions that have an increased risk of malignant transformation. Their treatment, therefore, is essential to prevent carcinogenesis. However, optimal therapy is not well established and different modalities yield variable results. Ingenol mebutate gel has recently been approved by the US Food and Drug Administration for topical treatment of actinic keratosis, with high clearance rates. On the basis of these findings, we report our experience with this drug for the treatment of AC.

Steroid-responsive atypical marginal zone hyperplasia of the lip in a child.

Atypical marginal zone hyperplasia (AMZH) is a recently described disease entity seen mainly in children. AMZH most commonly affects tonsils and appendices. Cutaneous AMZH is rare. The authors report here a recurrent AMZH in the lip of a 9-year-old child who presented originally with a lip swelling for approximately 3 months. The lip lesion recurred after each incomplete excision for 4 times. Pathologically, the lesion demonstrated marginal zone B-cell hyperplasia with kappa monoclonality by flow cytometry and immunohistochemistry studies. Lymphoepithelial lesions were noted with involvement of minor salivary glands. Polymerase chain reaction for immunoglobulin heavy-chain gene rearrangement has been repeatedly negative. Polymerase chain reaction for Borrelia species DNA was negative on both paraffin-embedded tissue and plasma. Serum antibodies IgG and IgM for Helicobacter Pylori were positive. A diagnosis of AMZH was made. Two courses of anti H. Pylori therapy did not improve the lip lesion, which completely regressed after a course of prednisone therapy. With differential diagnosis of cutaneous marginal zone lymphoma, the case illustrated diagnostic challenges, especially with recurrent lesions. This is the first case of recurrent cutaneous AMZH that has uncharacteristic kappa light-chain restriction. AMZH should be considered in children with mucocutaneous lesions with features of marginal zone lymphoma.

Lip and Perioral Enhancement: A 12-Month Prospective, Randomized, Controlled Study.

BACKGROUND: Juvéderm® Volbella® with Lidocaine is a hyaluronic acid filler suited for lip enhancement. OBJECTIVE: Evaluate the safety and effectiveness of Juvéderm Volbella with Lidocaine versus non-animal stabilized hyaluronic acid with lidocaine (Restylane-L®). METHODS: This study randomized 280 subjects desiring lip enhancement to Juvéderm Volbella with Lidocaine or Restylane-L. Investigators rated outcomes using Allergan's Lip Fullness Scale (LFS), Perioral Lines Severity Scale, and Oral Commissures Severity Scale. Independent central reviewers (ICRs) assessed 3-dimensional photographs using these scales. Noninferiority of Juvéderm Volbella with Lidocaine to Restylane-L was based on ICR assessment of LFS responders (≥ 1-point improvement from baseline) at month 3. Subjects were evaluated up to 12 months and after repeat treatment. RESULTS: Juvéderm Volbella with Lidocaine was noninferior to Restylane-L at 3 months. Investigator assessments showed significant improvements in lip fullness (P ≤ .03), perioral lines (P ≤ .04), and oral commissures (P ≤ .03) with Juvéderm Volbella with Lidocaine versus Restylane-L at months 6 to 12. There was less acute swelling and fewer severe injection site responses with Juvéderm Volbella with Lidocaine. Safety and effectiveness of repeat treatment with Juvéderm Volbella with Lidocaine was comparable to initial treatment, regardless of initial filler. CONCLUSIONS: Juvéderm Volbella with Lidocaine is safe and effective for lip and perioral enhancement, with effectiveness lasting up to 12 months.

Effect of hydralazine on duration of soft tissue local anesthesia following dental treatment: a randomized clinical trial.

Prolonged numbness following routine dental treatments can cause difficulties in speaking and swallowing and may result in inadvertent biting of soft tissues. Local injection of vasodilator agents may represent a solution to this problem. The aim of this study was to evaluate the effect of submucosal injection of hydralazine hydrochloride (HCl) on the duration of oral soft tissue anesthesia after routine dental treatment. This randomized, single-blinded, controlled clinical trial included 50 patients who received inferior alveolar nerve block (2% lidocaine with 1:100,000 epinephrine) for simple restorative treatment. Upon completion of the dental treatment, patients randomly received a hydralazine HCl or sham injection in the same site as the local anesthetic injection. The reversal time to normal sensation of soft tissues (lips, tongue, and perioral skin) was evaluated and reported every 5 minutes by the patients, who followed an assessment protocol that they were taught in advance of treatment. Median recovery times in the hydralazine group and the sham group were 81.4 (SD, 3.6) and 221.8 (SD, 6.3) minutes, respectively. Based on Kaplan-Meier survival analysis, the duration of soft tissue anesthesia in the 2 groups was significantly different (P < 0.0001). By 1 hour after the reversal injection, 76% of subjects receiving hydralazine HCl had returned to normal intraoral and perioral sensation, but none of the subjects in the sham group reported normal sensation. Based on these results, submucosal injection of hydralazine HCl can be considered a safe and effective method to reduce the duration of local anesthetic-induced soft tissue numbness and the related functional problems.

An interrater and intrarater reliability study of 3 photographic scales for the classification of perioral aesthetic features.

BACKGROUND: Validated aesthetic rating scales for the perioral area provide objective evaluations for clinical trials and practice. OBJECTIVE: To confirm the reliability of 3 scales for evaluating dermal filler and neurotoxin treatments of the perioral area. MATERIALS AND METHODS: Three lip-specific photographic scales were developed from standardized 2-dimensional images to evaluate Perioral Lines at Rest (POL), Oral Commissures (OCS), and Perioral Lines at Maximum Contraction (POLM) severity scales. Each 4-grade scale (none to severe) had 3 representative images per grade. Physician validators rated volunteers on each scale (2 rounds of live review). Volunteers provided 2 series of self-assessments. Physician and subject intrarater reliability were based on the comparison of round 1 and round 2 scores (mean weighted kappa coefficient). Other measures were physician interrater agreement (intraclass correlation) and subject/physician interrater agreement (Pearson correlation). RESULTS: Physician intrarater agreement was almost perfect or substantial (POL, 0.725; OCS, 0.789; POLM, 0.826). Overall, physician interrater agreement was almost perfect for all 3 scales and ranged from moderate to substantial by grade. Subject intrarater agreement and subject/physician interrater agreement were substantial. CONCLUSION: All scales demonstrated a high degree of intrarater and interrater reliability during the validation process. Physician concordance was good; subject ratings were reliable and comparable to physician assessments.