A randomized controlled pilot study of a proprietary combination versus sunscreen in melasma maintenance.

BACKGROUND: Melasma is the commonest cause of facial hypermelanosis in skin type IV-VI. First-line treatment includes a triple combination containing topical corticosteroid and hydroquinone which have side effects on prolonged use. Chemical peels are a second-line management option with the laser being used in refractory cases, but the worsening of hyperpigmentation in darker skin types can occur following laser therapy. Sunscreen is a must to prevent relapses. AIMS AND OBJECTIVES: (i) To compare the effects of treatment with a proprietary combination (phenyl ethyl resorcinol, nonapeptide-1, aminoethyl phosphinic acid, antioxidants and sunscreen) versus sunscreen alone in limiting or reducing, melasma and preventing recurrence as a maintenance regimen after the initial use of triple combination,(ii) to evaluate the safety of the formulation studied, and (iii) to study the improvement of the quality of life of the patients after using the study formulation versus placebo. METHODS: It was a prospective double-blinded parallel-group randomized controlled pilot study. A total of 46 subjects were recruited by consecutive sampling methods and randomized to 23 each in case and control groups. The study period was eight months with three phases. Phase 1 constituted the application of triple combination for eight weeks by both groups followed by phase 2 with the case group applying proprietary medicine and the control group applying sunscreen. Phase 3 was a follow-up period to see the sustenance of results in both groups as well as any evidence of relapses. Sunscreen was applied in all three phases. RESULTS: Case group in the study showed improvement in the melasma severity score and mean melanin index as measured by mexameter but it did not attain statistical significance as compared to the control group. The melasma area and severity index score showed a consistent reduction in the case group, whereas it increased in the control group from baseline. LIMITATIONS: Small sample size and a short follow-up period of our study were major limitations. CONCLUSION: The proprietary combination, which has sunscreen as one of its constituents, is more effective in maintaining remission after triple combination without any added inconvenience of application of two separate preparations as compared to sunscreen alone.

A randomized study to evaluate the efficacy and effectiveness of two sunscreen formulations on Indian skin types IV and V with pigmentation irregularities.

BACKGROUND: Regular exposure to ultraviolet rays is high in India, where most Indians present Fitzpatrick skin phototypes IV and V. AIMS: To evaluate the efficacy and compare the effectiveness of two sunscreen products on Indian skin types IV and V with pigmentation irregularities. METHODS: A randomized, uncontrolled and investigator-blinded, single-center study enrolled adult men and women (18-45 years) with Fitzpatrick skin phototypes IV (28° < individual typological angle <10°) and V (10° < individual typological angle < -30°) with pigmentary abnormalities seen on the face in adults (actinic lentigines and postinflammatory hyperpigmentation), who did not use sunscreens. Participants were randomized (1:1) to either of the two marketed sunscreen products, Product A (sun protection factor 50 PA+++) or Product B (sun protection factor 19 PA+++), applied twice daily before sun exposure for ≥2 h. Primary objectives aimed at assessing possible improvement in hyperpigmented spots and overall skin appearance after 12 weeks of use. Evaluation of skin radiance and skin color was done by means of L'Oréal color chart and colorimetric measurements (Chromameter®). RESULTS: Among the 230 enrolled participants, 216 (93.91%) completed the study. The clinical assessment of the density of pigmented spots and skin radiance showed significant (P < 0.001) improvement in both groups during all visits. The qualitative (participant perception) and quantitative (Chromameter®) data indicated improvement in pigmentation from Week 0 to Week 12. Both products were well-tolerated. LIMITATIONS: The study was conducted over a rather short period of time (12 weeks) at a single location. CONCLUSIONS: This is the first study conducted on Indian skin phototypes IV and V under real-life conditions. It demonstrated the effect of regular sunscreen usage in the prevention of certain signs of skin photoaging such as increased pigmentation or pigmentary abnormalities, thus providing support and assistance to clinicians in suggesting the use of efficient sun-screening products to patients.

Does using a high sun protection factor sunscreen on face, along with physical photoprotection advice, in patients with melasma, change serum vitamin D concentration in Indian conditions? A pragmatic pretest-posttest study.

BACKGROUND: Use of sunscreens on the face is becoming popular, and patients with melasma are prescribed sunscreen for use on the face. Results of a few Western studies on the effect of sunscreen use on serum vitamin D concentration are not applicable to Indian conditions. AIMS: To examine the effect of use of a high sun protection factor (SPF 50+, PA++++) sunscreen on face in patients with melasma on serum concentration of 25-hydroxyvitamin D. METHODS: Forty-five Indian patients (Fitzpatrick skin types III and IV) with melasma were advised to use a sunscreen with SPF 50 + for 3 months, 43 (33 female, 10 male; age 32.9 ± 8 years) completed the study. Patients staying outdoor for <4 hours applied sunscreen once daily after bath. Patients staying outdoors for >4 hours reapplied sunscreen 4 hours after first application. Patients were provided a container to measure the amount of sunscreen for use, which was approximately equal to recommended thickness. Compliance was tested by weighing the used tubes and tubes in use during monthly visits. Serum concentration of 25-hydroxyvitamin D was tested before and after the study period. RESULTS: Amount of sunscreen advised (100.5 ± 29.2 ml) and the actual amount used (96.6 ± 27.9 ml) were similar (P = 0.53, t-test). The difference between serum concentrations of 25-hydroxyvitamin D at the baseline (19.20 ± 9.06 ng/ml) and at 3 months (18.91 ± 8.39 ng/ml) was not significant (P = 0.87, paired t-test, 95% confidence interval of difference -3.33 to 3.92). No correlation was found between the amount of sunscreen used and the percentage change in serum 25-hydroxyvitamin D concentration at 3 months (rho = 0.099, P = 0.528, Spearman's rank correlation). LIMITATIONS: Longer duration of application and a larger sample size may detect minor differences in vitamin D concentration. CONCLUSION: Using a high SPF sunscreen on the face, along with physical photoprotection advice, in patients with melasma for 3 months does not influence serum 25-hydroxyvitamin D concentration in Indian conditions.

Photoprotection and vitamin D status: a study on awareness, knowledge and attitude towards sun protection in general population from Kuwait, and its relation with vitamin D levels.

BACKGROUND: The primary cause of skin cancers is exposure to ultraviolet (UV) radiation. And, for decades sun protection has been promoted in various public health education campaigns. Recently, however, vitamin D deficiency has been related to increased risk of skin cancers. And, skin being the primary site for the synthesis of active form of vitamin D, excessive sun protection could lead to vitamin D-deficient states. But, the results have so far been conflicting. AIMS: To study the level of awareness, knowledge and attitude of representative groups from the general population from Kuwait towards sun protection. And, also study the correlation of the level of sun protective measures used and vitamin D levels in these groups. METHODS: The study constituted of two main parts. First part comprised a questionnaire-based survey of representative group of people aged 18 and above to assess their knowledge, awareness and attitude towards sun protection. The second part consisted of measuring serum vitamin D levels in 150 volunteers amongst the responders of the questionnaire, who had been regularly using sunscreens for at least 2 years and compare to the levels seen in 150 age and sex-matched responders of similar skin phototypes, who had never used sunscreens. RESULTS: Out of the total of 1044 responders, 80% of them had adequate knowledge of the beneficial and harmful effects of sun exposure, and had been using sunscreens regularly, and adopting other sun protective measures in their daily life. The levels of vitamin D were found to be deficient in both sunscreen users and those who had never used sunscreens. The difference between the two groups was statistically insignificant (60.67% vs 54.67%; P value>0.001). CONCLUSION: Population at large seems to be adequately informed about the beneficial and deleterious effects of sun exposure. Vitamin D levels are deficient in majority of our people, and there is a need to do larger surveys covering all parts of the country and give supplemental doses of vitamin D to those found deficient.

Physical sunscreens: on the comeback trail.

Awareness of ultraviolet radiation-induced skin damage creates the need for the development of broad-spectrum, safe and cosmetically acceptable sunscreens. Being relatively inert, safe, stable and non-irritating, physical sunscreens are particularly useful for patients with sensitive skin who cannot tolerate chemical sunscreens. However, they form a thick visible pigment layer on the skin. To overcome this drawback, microfine oxides have been developed which made the sunscreens virtually transparent when applied on the skin. This article reviews the rationale for the comeback of physical sunscreens by analyzing data from various sources.