68 SKIN CARE


■ Having superinfected AD or presenting other dermatological disorders or a chronic or advancing disease ■ Any history of an allergy or hypersensitivity reaction to a cosmetic product or for an ingredient of the product supplied for the test Only subjects in total remission after the


prior drug treatment were included in the study. In order for a subject to be considered cured, the sum of SCORAD (SCORing Atopic Dermatitis) items (erythema, edema/papulation, oozing/scabs, excoriation and pruritus) were required to be 0 (the scoring scale is in the range of 0 = absence to 3 = severe). Subjects in remission applied either the


placebo formula (petrolatum, cetearyl alcohol, paraffinum liquidum, ceteareth-20, sodium phosphate, chlorocresol, phosphoric acid, sodium hydroxide and water) or the formula containing 0.5% Ophiopogon japonicus root extract with the same other ingredients, for a maximum of 60 days. The creams tested were formulated, packaged and identified by Silab. Each product was applied to the entire


body (healthy and previously affected zones) in the morning and evening. No other cosmetic or drug treatment for the same indications was used throughout the entire study. All subjects included in the study in both the placebo group and the Ophiopogon japonicus group also received the same product for daily body hygiene (Avène Pédiatril cleansing foam), which was used daily throughout the entire study.


Criteria of efficacy The clinical efficacy of the treatment was assessed after 30 and 60 days of application, based on an evaluation by the dermatologists and an evaluation by the patients themselves. The primary efficacy variable observed by the dermatologists was the change in AD clinical severity index (SCORAD). This combines objective assessments of the


extent of body surface area involvement in AD (the severity of erythema, edema/papulation, oozing and crusting, excoriation, lichenification, and skin dryness, with a scoring scale in the range of 0 = absence to 3 = severe), with subjective measures (pruritus and sleep loss with a scoring scale in the range of 0 = absence to 10 = severe). A ≥25% reduction in the index is consistent with concluding on the clinical efficacy of the treatment in question. This was complemented by an overall


evaluation determined by the dermatologists using a questionnaire, after 30 and 60 days of twice-daily application. It included the following six statements: ■ The product can be claimed to have a hydrating effect ■ The product can be claimed to have a soothing effect ■ The product attenuates the intensity of flares ■ The product attenuates the frequency of flares ■ The product is perfectly tolerated ■ The product is satisfying overall ■ There were five possible answers to the previous-mentioned items: agree; mostly agree; mostly disagree; disagree; no opinion. Secondary efficacy endpoints included the evaluation of the quality of life by subjects


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0


-10 -20 -30 -40 -50 -60 -70 -80


D30


D60


-31*


-36* -56* -76*


Placebo group ■ 0.5% Ophiopogon japonicus group ■ * Significant differences/D0 (p<0.05)


Figure 2: Changes of SCORAD after 30 & 60 days of twice daily application


via the Dermatology Life Quality Index (DLQI), which was to be filled on D0, D30 and D60. This questionnaire of ten questions (details not shown) is used to determine the impact of atopic dermatitis on the quality of life of the subject. The DLQI is determined by the sum of scores


for each of the 10 questions; the maximum index is 30 and the minimum is 0. Scores measuring the effect on the subject’s life are: ■ 0-1: No effect ■ 2-5: Slight effect ■ 6-10: Moderate effect ■ 11-20: Important effect ■ 21-30: Extremely important effect ■ A higher index means that the quality of life of the subject is affected to a greater extent. Finally, an overall evaluation of the efficacy of the product was assessed via a self-evaluation by the subjects. It was conducted after 30 and 60 days of twice daily application using a questionnaire, including in particular eight items: ■ The product delays the next eczema relapse ■ The product justifies the claim for hydrating efficacy ■ The product provides daily comfort and wellbeing ■ The product is safe for the skin (no embarrassment, discomfort or irritation) ■ The product is pleasant to use ■ I will continue to use this product ■ The product is satisfying overall ■ The product is effective overall There were five possible answers to items


1 to 7: agree; mostly agree; mostly disagree; disagree; no opinion. Concerning the overall efficacy of the product tested (item 8), subjects were asked to evaluate efficacy with the following scale: very effective; effective; slightly effective; not effective.


Results In the conditions of this study, dermatologists observed a 36% reduction of the SCORAD index on D30 in the Ophiopogon japonicus group compared to 31% in the placebo group. This result is strengthened on D60, with a 76% reduction of the SCORAD index in the Ophiopogon japonicus group (p<0.05) compared to 56% in the placebo group. These results show the good efficacy of


the Ophiopogon japonicus treatment in Asian adults with atopic skin (Figure 2). In the conditions of this study, after 30


and 60 days of use on the entire body, the dermatologists noted that the Ophiopogon japonicus root extract was perfectly accepted while presenting a higher soothing and hydrating effect than the placebo formula, the latter being significant on D60. The quality of life of subjects using the


Ophiopogon japonicus root extract is improved as of 30 days after starting applications and compared to D0. This effect continued up to 60 days of using the Ophiopogon japonicus root extract. The deterioration of the DLQI index was reduced by 68% compared to 47% in the placebo group (Figure 3). In addition, the overall assessment by the


subjects on D30 in the same conditions also highlights better results for the Ophiopogon japonicus group than for the placebo group, especially for the hydrating effect and the overall efficacy of the product. In particular, after 60 days of use on the


entire body, the subjects who had used the Ophiopogon japonicus root extract found it satisfying and effective overall. According to them, in addition to being pleasant to use, it provided daily comfort and wellbeing and a significant hydrating effect. 82% of them were willing to continue to use this product, compared to only 73% in the placebo group.


Discussion & conclusion This study demonstrated the efficacy of Ophiopogon japonicus root extract in reducing AD severity and frequency in Asian adults with mild to moderate AD. To evaluate the long-term relief, product efficacy was assessed during a two-month period of application, which was considered to be a more relevant timeframe when focusing on the remission phase than shorter periods mentioned elsewhere.4,5,6 In the present study, SCORAD index was


preferred over the Eczema Area & Severity Index (EASI) score, because SCORAD measures demonstrate a better ability to discriminate between patients who improved and those who did not.7


Moreover, the product


treatment presented a favourable safety profile with balanced adverse events and similar discontinuation rates between treatments. Lastly, an aim of this study was to provide


a natural solution that would delay the use of topical corticosteroids (TCSs), a primary therapy used to treat inflammation in AD8


. Despite their www.personalcaremagazine.com


Variation/D0 (%)


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