Treatment of keloids and hypertrophic scars. Position statement of the Brazilian expert group GREMCIQ.

Keloids (K) and hypertrophic scars (HS) are abnormal responses to wound healing that occur as the result of dermal inflammation. Despite the advances on their treatment, many patients still suffer from the negative effects of excessive scarring; its approach is impaired by the lack of objective data on different treatments and the large genetic variability among patients and the difficulties in producing multicentre studies. Their incidence among the Brazilian population is high, as the result of an admixture of Amerindians, Europeans and Africans ancestral roots. With the aim of producing multicentre studies on K and HS, a panel of senior Brazilian dermatologists focused on their treatment was invited to contribute with the K and HS Treatment Brazilian Guidelines. In the first part of this study, different treatment modalities for keloids and HS are fully reviewed by the panel. The second part of the study presents a consensus recommendation of treatment for different types of lesions. More than a literature review, this article aims to show the pitfalls and pearls of each therapeutic option, as well as a therapeutic approach by the Panel of Experts on keloids and Scars on a highly mixed population, providing simple guidelines.

Triple combination as adjuvant to cryotherapy in the treatment of solar lentigines: investigator-blinded, randomized clinical trial.

BACKGROUND: Post-inflammatory hyperpigmentation is a frequent concern when treating solar lentigines. OBJECTIVES: To assess the safety and efficacy of a triple combination cream with fluocinolone acetonide 0.01%, hydroquinone 4% and tretinoin 0.05% as adjuvant to cryotherapy in the treatment of solar lentigines in hands dorsum, and in the prevention of post-inflammatory hyperpigmentation after cryotherapy. METHODS: This prospective, randomized, controlled, investigator-blinded, single-centre study enrolled 50 patients. Twenty-five patients received a 2-week daily triple combination cream plus sunscreen pre-treatment and 25 received sunscreen alone. After that, cryotherapy was performed in all patients followed by a 3-week recovery period. After this period, patients received the same initial treatment and were followed up for 8 weeks. Melanin and erythema levels of a target and a control lentigo were objectively measured using a narrowband reflectance spectrophotometer. Lentigines count, colour homogeneity and global improvement were also assessed. RESULTS: The number of solar lentigines reduced in the first 2 weeks only in patients who used the triple combination 25 ± 7 vs. 22 ± 8 (P < 0.0001), and reduced at the end of the study for both groups (P < 0.0001). The melanin levels also reduced in the first 2 weeks only in patients who used the triple combination 297 ± 69 vs. 273 ± 66 (P < 0.0001) and reduced at the end of the study for both groups (P < 0.0001). Erythema and residual blisters from cryotherapy were the reported adverse reactions. CONCLUSION: Triple combination cream can be used to enhance the resolution of solar lentigines, and to significantly reduce melanin levels and lentigines count, improving treatment results. It was well-tolerated and did not increase the occurrence of neither erythema nor other side-effects after the cryotherapy.

Preventing melasma recurrence: prescribing a maintenance regimen with an effective triple combination cream based on long-standing clinical severity.

BACKGROUND: The relapsing nature of melasma emphasizes the need to maintain efficacy achieved after acute treatment. OBJECTIVE: To compare clinical efficacy and safety of two 6-month Triple Combination (TC; containing fluocinolone acetonide, hydroquinone and tretinoin) maintenance regimens in subjects with moderate to severe melasma, after daily treatment up to 8 weeks. METHODS: This randomized, investigator-blinded, controlled study had a maintenance phase of 6 months. Sixteen centres in Brazil and Mexico enrolled 242 subjects 18 years or older attaining no or mild melasma after 8 weeks of daily TC applications. Subjects were randomized to receive TC in a twice weekly or tapering regimen [3/week (1st month), 2/week (2nd month), 1/week (4th month)]. Efficacy and safety measurements included median time to relapse and relapse-free rate, Global Severity Score, Melasma Area and Severity Index score (MASI), subject's assessment, quality of life questionnaire (MelasQol), and adverse events. RESULTS: The majority (78.8%) had no or mild melasma (GSS ≤ 1) at week 8 and entered maintenance phase. After 6 months, 53% of patients remained relapse-free with improved quality of life, and time to relapse was similar between groups (about 190 days). Melasma severity at study entry, not maintenance baseline, influenced relapse rate. The twice weekly regimen tended to show better effectiveness in postponing relapse in severe melasma. Both regimens were safe. CONCLUSIONS: After resolution of melasma with TC, maintenance therapy over 6 months was successful in preventing relapse in over half of the patients who entered maintenance phase. Prescribing medicines should be adapted to patients based on melasma severity.

International consensus recommendations on the aesthetic usage of botulinum toxin type A (Speywood Unit)--Part II: Wrinkles on the middle and lower face, neck and chest.

BACKGROUND: Azzalure® (Galderma SA), a newly approved European botulinum neurotoxin type A (BoNT-A), is derived from Dysport™ (Ipsen Ltd.), which has a 20-year history of product consistency and has been widely used for various aesthetic and therapeutic applications. Azzalure® and Dysport™ are collectively referred to as BoNT-A (Speywood Unit) after the unit of their activity, and are distinct from other commercial BoNT-A preparations. Consensus has been developed for the treatment of upper facial wrinkles with BoNT-A (Speywood Unit). OBJECTIVE: To provide consensus recommendations on the treatment with BoNT-A (Speywood Unit) for wrinkles on the middle and lower face, neck and chest region. METHODS: The members of the International Board on Botulinum toxin Azzalure (IBBA) convened to develop consensus based on their extensive experience. RESULTS: The recommended final concentration of BoNT-A (Speywood Unit) is 200 Speywood Units/ml after reconstitution. The consensus recommendations were provided for nine indications, including lower eyelid wrinkles, bunny lines, drooping nasal tip, perioral wrinkles, masseter hypertrophy, drooping mouth corners, dimpled chin, platysmal bands and décolleté wrinkles. For each indication, anatomy of the region to be treated was discussed, as were potential side-effects. The consensus recommendations included the number and location of the injection points, dose range of each point and the total injection, as well as specific injection technique. CONCLUSION: These recommendations provide a guideline for physicians who wish to perform safe and efficacious treatment with BoNT-A (Speywood Unit) on the less commonly treated middle and lower face, neck and chest region.

International consensus recommendations on the aesthetic usage of botulinum toxin type A (Speywood Unit)--Part I: Upper facial wrinkles.

BACKGROUND: Azzalure (Galderma SA) is a newly approved European botulinum neurotoxin type A (BoNT-A). It is derived from Dysport (Ipsen Pharma), which has a long history of usages in various applications. Azzalure and Dysport are collectively referred to as BoNT-A (Speywood Unit) and are different from other BoNT-A preparations. OBJECTIVE: To provide consensus recommendations on the treatment of upper face wrinkles with BoNT-A (Speywood Unit). METHODS: The members of the International Board on Botulinum toxin Azzalure (IBBA) convened to develop consensus on the treatment of upper facial wrinkles based on their own extensive experience. RESULTS: The consensus recommendations address the general issues regarding treatment and provide specific guidelines on the anatomy, injection points, dose, injection technique and safety precautions concerning each common upper face indication. The recommended final concentration of BoNT-A (Speywood Unit) is 200 s.U/mL (10 s.U/0.05 mL) after reconstitution. For glabellar lines, the members recommend a total of five injection points with 10 s.U/point. For forehead wrinkles, the members recommend four to six injections into the frontalis with 5-10 s.U/point. For crow's feet, the members recommend three injections per side with 5-10 s.U/point at the lateral part of the orbicularis oculi. For lateral eyebrow lift, the members recommend one point at each eyebrow tail and an additional one in each side of the frontalis with 5-10 s.U/point. CONCLUSION: This guideline provides a framework for physicians who wish to perform safe and efficacious injection of BoNT-A (Speywood Unit).

Melasma in Latin America: options for therapy and treatment algorithm.

OBJECTIVE/AIM: To examine approaches to therapy for melasma in Latin Americans and to propose treatment algorithms for patients with mild, moderate and severe melasma. BACKGROUND: Melasma is prevalent in up to 10% of the Latin American population. It is found in all racial groups and is more common in subjects with darker skin phototypes. A number of topical treatments and procedures have been used for melasma. Topical treatments containing hydroquinone are the most popular. Care must be taken when treating melasma to avoid inducing post-inflammatory hyperpigmentation and ochronosis. Determination of the severity of melasma (using the Melasma Area Severity Index and/or Physician's Global Assessment) and choice of the most effective and suitable treatment and/or procedure for individual patients is therefore essential. Sun protection is mandatory for all melasma patients. METHODS: Thirty-one clinical studies of topical treatments, chemical peels and laser and other therapies used for treating melasma were assessed for the level and quality of clinical evidence, by the Latin American Pigmentary Disorders Academy. The results of this analysis were combined with differential diagnosis guidelines and methods for assessing treatment success to establish algorithms for treating mild and moderate-to-severe melasma. RESULTS: The most appropriate first-line treatment for mild melasma is hydroquinone 4%, triple combination cream containing hydroquinone 4%, tretinoin 0.05% and fluocinolone acetate 0.01%, double combination (e.g. 4% hydroquinone and 0.1% tretinoin) or non-phenolic therapy where there is an allergy to compounds. In moderate-to-severe melasma, triple combination cream is the recommended first-line treatment. Second-line treatment is double combination or hydroquinone 4% where triple therapy is not available or if allergic to compounds. Sun avoidance measures and broad spectrum sunscreens with high SPF are fundamental for the successful management of the disease.

A global survey of the role of ultraviolet radiation and hormonal influences in the development of melasma.

BACKGROUND: It has been generally believed that the four main causes of melasma are pregnancy, hormonal contraception, family history and sun exposure; however, there are few published comprehensive studies that confirm these assertions. The Pigmentary Disorders Academy - an international group of experts in pigmentary disorders - designed and conducted a global survey of women to investigate the effect of these factors on onset and chronicity of melasma and the course of the disease in order to gain a better understanding of the causative factors associated with this disorder, with a particular focus on hormonal factors and UV exposure in females. METHODS: A 40-item largely self-administered questionnaire was completed by 324 women being treated for melasma in nine clinics worldwide. RESULTS: The mean age at onset of melasma was 34 years, and 48% of subjects questioned had a family history of melasma (97% in a first-degree relative). Subjects with family history of melasma tended to have darker skin (90% types III-VI) compared to those without (77% types III-VI). The most common time of onset was after pregnancy (42%), often years after the last pregnancy, with 29% appearing pre-pregnancy and 26% during pregnancy. Onset was related to darker skin type post-pregnancy (P = 0.002). Risk of onset during pregnancy was associated with having spent more time outdoors (an extra 10 h per week spent working outside increases the odds of onset of melasma during pregnancy by approximately 27%) and an increased maternal age at pregnancy (increased by approximately 8% for each year of age at first pregnancy; P = 0.02). The odds of melasma occurring for the first time during a pregnancy were also increased with multiple pregnancies (twice the odds if 2 vs. 1 pregnancies, three times higher if 3 or more vs. 1 pregnancy). Of the women, 25% who had used hormonal contraception claimed that melasma appeared for the first time after its use, the rate being higher for those without vs. with a family history. CONCLUSIONS: The results suggest that, whilst accepted causes do affect onset of melasma, a combination of these factors often triggers this disorder. These factors may provide further insights into how physicians can manage individual melasma cases, support recommendation of preventative measures and even anticipate treatment results and recurrence.

A validated photonumeric cellulite severity scale.

BACKGROUND: With recent advances in the treatment of cellulite and localized fat, a comprehensive objective method of measuring cellulite can be potentially useful, especially since important morphological aspects of cellulite are not part of the current classification. Objective To develop and to validate a new photonumeric cellulite severity. METHODS: Based on standardized photographs of 55 patients with cellulite, five key morphological aspects of cellulite were identified. A new photonumeric severity scale was developed and validated. RESULTS: The five key morphological features of cellulite were identified and included the number of depressions, depth of depressions, clinical appearance of evident raised lesions, and presence of flaccidity and the grade of cellulite. Each item was graded from 0 to 3, allowing final classification of cellulite as mild, moderate, and severe. Results for validation of the scale are statistically significant (P < 0.05) and are as follows: intraclass correlation coefficient > 0.7; correlation item-total > 0.7, with the exception of the right buttock; intraclass correlation coefficients 0.881-0.922; Cronbach's alpha 0.851-0.989 and factor analysis 68-76%. CONCLUSION: The proposed photonumeric scale is a consistent, comprehensive, reliable, and reproducible tool for the standardized and objective assessment of the severity of cellulite. Conflicts of interest The authors hereby affirm that neither the manuscript nor any part of it has been published or is being considered for publication elsewhere.

Ethnic considerations in the treatment of Hispanic and Latin-American patients with hyperpigmentation.

Latin-Americans have a heterogeneous ancestry that is defined by their place of domicile, while Hispanics are defined as those persons of Spanish descent. These two groups have a diverse range of skin phototypes and pigmentation and are prone to an increased incidence of melasma and post-inflammatory hyperpigmentation. Little research has been conducted to evaluate the frequency, course, effects, tolerability and treatment response of skin diseases in Hispanic and Latin-American populations. From the limited data that are available it is considered that the treatment of melasma in these two groups does not differ from the general population. First-line therapy of melasma should consist of effective topical therapies, mainly a fixed triple combination of hydroquinone, retinoic acid and fluocinolone acetonide. Where patients have either sensitivity or triple combination therapy is unavailable, other compounds with dual ingredients may be considered as an alternative. Options for second-line therapy include peels either alone or in combination with topical therapy. Lasers should rarely be used in the treatment of melasma and then only as third-line therapy in cases of melasma which is resistant to all other therapies. If applied, skin type must be taken into account. Irritation and sensitivity can be a concern in darker-skinned Hispanic patients and for this reason, the risk of post-inflammatory hyperpigmentation (PIH) following treatment should be considered.

Validation of a melasma quality of life questionnaire for Brazilian Portuguese language: the MelasQoL-BP study and improvement of QoL of melasma patients after triple combination therapy.

BACKGROUND: Pigmentation disorders, such as melasma, greatly influence the quality of life (QoL) of affected individuals who usually consider the disorder to be more severe than the objective clinical scores. Several instruments have been successfully developed to evaluate QoL. However, they must be adapted to the target population in terms of language and cultural diversity. The first, specific QoL questionnaire for melasma (MelasQoL) was developed for English speaking patients. OBJECTIVES: To validate the Brazilian Portuguese version of the MelasQoL evaluation questionnaire for patients with melasma (MelasQoL-BP) and to assess the impact of treatment with a triple combination cream (hydroquinone, fluocinolone acetonide and tretinoin) on the QoL of patients with moderate-to-severe melasma. METHODS AND RESULTS: Three hundred individuals from the five Brazilian geographic regions took part in this multicentre study. Their mean age was 42 years and skin phototype distribution was: type II 7.0% of patients, III 23.7%, IV 42.7% and V 22.7%. Melasma Area and Severity Index (MASI), MelasQoL-BP and the short version of the QoL assessment instrument from the World Health Organization (WHOQOL-BREF) were used to assess melasma severity and QoL at baseline. MelasQoL-BP was previously translated and culturally adapted from the English version, with participation of the authors and according to the standards of the World Health Organization (WHO). From the original sample, we randomized150 volunteers to treat melasma and repeated the evaluation after 8 weeks. The analysis of the MelasQoL-BP baseline answers demonstrated an important impact of the disease on skin appearance (65% of patients were bothered all the time or most of the time), frustration (55%), embarrassment (57%) and influence of the disease on interpersonal relationships (42%). Forty-three per cent of patients felt not attractive or even dirty due to their skin condition. MelasQoL-BP results showed significant internal consistency (Cronbach's alpha coefficient 0.919; P < 0.001) and good correlation with MASI scores. After treatment, the global assessment showed good or excellent results in 91.4% of the patients. The clinical outcome was not associated with the initial MASI score (P = 0.814; chi-square), skin colour (P = 0.449; probability ratio) or skin pigmentation (P = 0.814; chi-square). There was also a significant reduction on MelasQoL-BP scores (Wilcoxon test; P < 0.001) after treatment, with the mean +/- SD results shifting from 44.4 +/- 14.9 at baseline to 24.3 +/- 15.5 after treatment. The analysis of the MelasQoL-BP before and after treatment showed an important effect of the impact of treatment on a number of QoL measures. Of note, skin appearance (69.8 vs. 10.1% of patients were bothered all the time or most of the time, respectively), frustration (59.7% vs. 12.2%, respectively), embarrassment (56% vs. 9.3%, respectively) and influence of the disease on interpersonal relationships (35.3% vs. 5.8%, respectively) were greatly improved. CONCLUSIONS: This study demonstrates that MelasQoL-BP is a valid instrument and can be used to evaluate the quality of life and response to melasma treatment in Brazilian patients. The triple combination treatment produced significant results, regarding both clinical severity and quality of life.

Subcision: a treatment for cellulite.

BACKGROUND: Cellulite is a common clinical condition, with few proven effective therapeutic options. Subcision is a surgical technique that is useful in treating advanced degree cellulite. This study was designed to determine the usefulness of the treatment of cellulite by subcision. METHODS: From January 1995 to January 1998, 232 female patients, aged 18-52 years, with cellulite on the thighs and buttocks were treated on an outpatient basis by the subcision technique. RESULTS: In the postoperative period, all the patients had pain, bruises, and hemosiderosis. An improvement in the surface depressions was observed and the patients reported a high degree of satisfaction. CONCLUSIONS: This outpatient procedure is effective in the correction of surface depressions on the thighs and buttocks, clinically classified as cellulite.

Clinical comparative study between cryotherapy and local dermabrasion for the treatment of solar lentigo on the back of the hands.

BACKGROUND: Solar lentigo is a common and unsightly dermatosis that has a variety of proposed treatments. OBJECTIVE: This study was done to assess the efficacy and the effectiveness of localized dermabrasion compared with cryotherapy with liquid nitrogen on solar lentigo on the back of the hands. METHODS: Ten female patients aged 64-96 years with solar lentigo on the back of the hands were treated with dermabrasion or cryotherapy and observed over a 6-month period. RESULTS: The postsurgery signs and symptoms were less intense and better tolerated with localized dermabrasion. More than 50% of the patients treated with cryotherapy still had hypochromia in the treated areas 6 months after treatment, compared with 11% of the patients treated with dermabrasion. The percentage of recurrence was the same with the both treatments (55.55%). CONCLUSION: Localized dermabrasion is an efficacious and effective technique comparable to cryotherapy for the treatment of solar lentigo on the back of the hands.