Clinical Efficacy of Fig Extract for Atopic Dermatitis Treatment in Children
Atopic dermatitis (AD) is a chronic, inflammatory skin disease characterized by severe pruritus or itchiness, and dryness of the skin. Because its development involves a complex interaction of genetic, environmental, and immunological factors, prescribing an effective treatment is difficult. Earlier studies have demonstrated that fig (Ficus carica, Moraceae) leaves and fruits are rich in polyphenols and may possess antioxidant, anti-inflammatory, antiviral, and antibacterial properties. These properties, particularly reducing inflammation, are often useful in treating AD. Therefore, these authors conducted a randomized, double-blind, placebo-controlled, clinical trial to investigate the effects of an aqueous extract of dried fig fruit on the severity of AD.
To prepare the treatment cream used in this study, samples (100 g) of edible fig fruit, purchased from local markets of Estahban County in Fars Province, Iran, in September 2014. The fruits were washed and macerated in 200 mL of water at 77° F (25° C) for one hour. After boiling in water for 10 minutes, the fruits were cooled and squeezed to a removed insoluble pulp. They were then concentrated to reach a honey-like consistency, and 40 g extract was extracted from 100 g fig (8% concentration). The Melfi cream contained aqueous fig extract and base cream. Total phenolic content of the extract, as determined by using Folin-Ciocalteu reagent, was 6.5 mg gallic acid equivalents per 1 g dried extract.
The placebo, a commercially available base cream supplied by Farabi Pharmaceutical Co. in Isfahan, Iran, contained cetostearyl alcohol, petroleum jelly, glycerin, mineral oil, preservative, and antioxidants. Hydrocortisone 1% cream was supplied by Emad Pharmaceutical Co. in Tehran, Iran.
The study was conducted from November 2014 to December 2015 at the Asthma and Allergy Clinic at Mofid Children’s Hospital in Tehran, Iran. To be included, patients had to be younger than 15 years and diagnosed with AD according to the Hanifin and Rajka Diagnostic Criteria for Atopic Dermatitis. Their AD severity was rated as mild to moderate according to a score of less than 50 on the SCORing Atopic Dermatitis (SCORAD) index. This measurement includes objective signs, such as extent and intensity, and subjective symptoms, such as daytime pruritus and sleeps disturbance. The patients were randomly assigned to use a fingertip unit of Melfi cream (n=20), hydrocortisone 1.0% cream (n=20), or placebo cream (P=19) on skin lesions twice daily for 14 days. The SCORAD index was determined at baseline and after 14 days of treatment.
Of the 59 patients assigned to a treatment group, nine were lost to follow-up (four in the hydrocortisone group, three in the Melfi cream group, and one in the placebo group). One patient in the hydrocortisone cream group and four patients in the placebo group dropped out of the study due to lack of efficacy, and one patient in the Melfi cream group was too busy to continue the study. The final analysis included 14 patients in the hydrocortisone cream group, 16 patients in the Melfi cream group, and 15 patients in the placebo group. Of those 45 patients, 22 were males. Mean ages of the patients were 38 months in the Melfi cream group, 28 months in the hydrocortisone cream group, and 27 months in the placebo group. A significant difference in gender was found among the three groups, with 13 males in the placebo group, four males in the Melfi cream group, and five males in the hydrocortisone cream group (P<0.01).
Compared with baseline, significant reductions were seen in the Melfi cream group on the SCORAD index (P<0.0001), in intensity (P<0.0001), and in pruritus (P<0.001). In the hydrocortisone cream group, significant improvements were observed in the SCORAD index (P<0.001), intensity (P<0.001), and pruritus (P<0.004) after 14 days of treatment compared with baseline. No significant improvements were seen in the placebo group.
A pairwise comparison of SCORAD index scores revealed greater reductions in the Melfi cream group than in the hydrocortisone cream group (P=0.046) and significantly better outcomes with the Melfi cream compared with the placebo cream (P<0.001). The improvements in pruritus were greater in the Melfi cream group compared with the hydrocortisone cream group (P=0.004), but no significant differences in intensity scores were observed (P=0.399).
During the second phase of the study, the patients were to be followed for 14 days after the end of treatment. Because only 30 patients were available for this phase, the authors did not report complete findings.
Overall, in the Melfi cream group, 11 patients were cured completely, SCORAD index decreased in three patients and increased in one patient, and one patient was not available for follow-up. In the hydrocortisone cream group, eight patients were cured completely, SCORAD index decreased in one patient and increased in one patient, and four patients were not available for follow-up. In the placebo group, one patient was cured completely, SCORAD index increased in four patients, and 10 patients were not available.
No adverse effects were reported by any of the patients during the study or its follow-up period.
The authors conclude that “safety, efficacy, tolerability, and symptom relief were considerable in fig fruit extract in comparison with hydrocortisone 1.0%,” suggesting that fig extract may be used instead of a low-potency corticosteroid cream in patients with mild to moderate AD. Limitations of the study include the need to refrigerate the Melfi cream as it did not contain preservatives and the fact that patients with severe atopic dermatitis were not included in the study. Other limitations include the small sample size and short duration of the study.
Abbasi S, Kamalinejad M, Babaie D, et al. A new topical treatment of atopic dermatitis in pediatric patients based on Ficus carica L. (fig): a randomized, placebo-controlled clinical trial. Complement Ther Med. December 2017;35:85-91. doi: 10.1016/j.ctim.2017.10.003.