11.6 Skin Diseases

BACKGROUND: Burn wounds rank among the most serious healthcare issues. Many studies reported the effectiveness of natural products in the wound-healing process. The present study compared the effects of a standardized herbal formulation derived from () and silver sulfadiazine (SSD) cream 1% on the healing of burn wounds.

METHODS: This randomized double-blind clinical trial was conducted at Shiraz Burn Hospital (Shiraz, Iran) between July 2012 to August 2013. A sterilized formulation comprising 40% was prepared. 54 second-degree burn patients of both sexes with age ranges of 20 to 60 were invited to participate in this double-blind, randomized clinical trial. They were randomly divided into two groups and given either the formulation or SSD cream. The healing index was determined based on the wound area assessment using the planimetry technique. The Kaplan-Meier survival analysis was used to assess the primary outcome, which was the amount of time until complete healing.

RESULTS: The trial was completed by 17 patients from the SSD group and 15 patients from the group. During the study period, both groups showed a progressive healing trend. The mean (95% CI) healing time in the SSD group was 10.94 (9.03-12.85) days and 10.73 (9.23-12.23) days in the group (P=0.71), indicating no significant difference. On the 17 day, the healing index of all patients in the group reached 1.

CONCLUSION: topical formulation had a burn wound healing effect comparable to that of the standard SSD 1% treatment. Based on the findings of this study, the likelihood of contact dermatitis with should be taken into consideration.

Bacterial nanocellulose has been widely investigated for wound healing applications, mainly due to its moisturizing capabilities and biocompatibility. Even though the topical therapy of nail diseases could benefit from these properties, this application has not yet been investigated. Therefore, actively hydrating nail patches based on bacterial nanocellulose were developed to improve the delivery of ciclopirox olamine and Boswellia serrata extract through the nail plate. The nanocellulose matrix was used to enable the application of hydration enhancing solutions based on glycerol and urea as a mechanically stable patch. While the favorable mechanical characteristics of the material remained unchanged, an increase of the incorporated glycerol concentration enhanced the transparency and wetting capacity of the patches. A biphasic drug release from the patches could be observed for drug and extract with a faster release for the hydrophilic ciclopirox olamine. High glycerol concentrations correlated with increased cumulative release and permeation through keratin films for drug and extract, demonstrating the hydration driven permeation enhancement. Patches containing ciclopirox olamine showed strong antimycotic effects against relevant pathogens for onychomycosis. The present finding proposed the combination of bacterial nanocellulose with glycerol, urea and different drug as a promising platform for the local treatment of nail diseases.

ETHNOPHARMACOLOGICAL RELEVANCE: Traditional Persian medicine manuscripts refer to plants such as Commiphora myrrha (Nees) Engl. (myrrh) and Boswellia carteri Birdw. (frankincense), which could be used to improve wound healing process. Since that time, local midwives in Iran continue to provide these herbs to precipitate episiotomy wound healing.

AIM OF THE STUDY: To investigate the efficacy and safety of myrrh- and frankincense-based sitz-baths on episiotomy wound healing in primiparous women.

MATERIALS AND METHODS: This randomized controlled trial was conducted on 90 primiparous women with singleton pregnancies after normal vaginal delivery at Hafez hospital affiliated to Shiraz University of Medical Sciences from July to October 2019. Study participants were randomly allocated in three groups (2 intervention groups and 1 control group). Women in intervention groups were assigned to receive either 10-min sitz-bath of myrrh extract or frankincense extract twice a day for 1 week. While the women in control group received the betadine sitz-bath for the same period of time. The main outcome was the episiotomy wound healing, which was measured using the REEDA scale before intervention, on 2nd and 7th postpartum days.

RESULTS: An improvement in the episiotomy wound healing was significantly greater in patients receiving myrrh than those receiving the frankincense or betadine on 2nd (p = 0.003 and p < 0.001) and 7th (p = 0.043 and p = 0.015) postpartum days. However, the total REEDA score was not statistically different between the frankincense and betadine groups on 2nd and 7th postpartum days (p > 0.05).

CONCLUSION: The present results suggest that myrrh was more efficient than frankincense and betadine in healing of the episiotomy wound and could be recommended as a safe natural therapy.

OBJECTIVE: Acute radiation erythema and other skin reactions are common adverse effects experienced by breast carcinoma patients undergoing radiotherapy treatment. Boswellic acids are pentacyclic triterpenes extracted from the resins of the tropical tree Boswellia serrata with strong anti-inflammatory properties. This study was designed to evaluate the safety and the efficacy of the application of a base cream containing boswellic acids in a proprietary formulation (Bosexil(R)) for the prevention and relief of radiation-induced adverse effects in breast cancer patients.

PATIENTS AND METHODS: The acute skin reactions were clinically evaluated by visual intensity and computer-assisted skin color analysis, and toxicity was assessed by the Radiation Therapy Oncology Group (RTOG) rating scale.

RESULTS: These findings indicate that the use of a boswellia-based cream is effective in reducing the use of topical corticosteroids and is able to reduce the grade of erythema and the skin superficial symptoms, being well tolerated by the patients.

CONCLUSIONS: Further studies comparing boswellia cream with other topical agents will be appropriate to confirm the effectiveness of this treatment for breast cancer patients under radiation therapy.

The four-herb Chinese medicine ANBP is a pulverized mixture of four herbs including Agrimonia Eupatoria (A), Nelumbo Nucifera Gaertn (N), Boswellia Carteri (B) and Pollen Typhae Angustifoliae (P). The combination of the four herbs was first described in Chinese canonical medicine about 2000 years ago for treatment of various trauma disorders, such as hemostasis, antiinflammatory, analgesia, and wound healing, etc. However, the precise mechanisms of ANBP are still unclear. In our study, using rabbit ear hypertrophic scar models of full-thickness skin defect, we showed that local ANBP treatment not only significantly enhanced wound healing by relieving inflammation, increasing formation of granulation tissue and accelerating re-epithelialization, but also reduced scar formation by decreasing collagen production, protuberant height and volume of scars, and increasing collagen maturity. We demonstrated that these effects of ANBP are associated with transforming growth factor (TGF)-β1-mediated signalling pathways through Smad-dependent pathways. ANBP treatment significantly increased expression of TGF-β1 and Smad2/3 mRNA at the early stage of wound healing, and led to markedly decrease expression of TGF-β1 and Smad2/3 compared with the control group after 14 days post-wounding. Taken together, our results defined a bidirectional regulation role of ANBP for TGF-β1/Smad pathway in promoting wound healing and alleviating scar formation, which may be an effective therapy for human wounds at the earliest stage.

BACKGROUND: Boswellic acids (BAs) show anti-inflammatory properties in a variety of inflammatory diseases, including rheumatoid arthritis, osteoarthritis, and asthma. A topical administration route is currently used to deliver active compounds in psoriatic and eczematous patients. In this double-blind study we compare a novel BA formulation (containing Bosexil(®), INCI [International Nomenclature of Cosmetic Ingredients]: lecithin, Boswellia serrata resin extract) with a placebo formulation. A third arm of the trial received a formulation of Vaccinium myrtillus seed oil, previously demonstrated as an effective local treatment for psoriatic lesions.

METHODS: Patients with psoriasis or erythematous eczema were randomly assigned, in a 1:1:1 ratio, to Bosexil(®), V. myrtillus seed oil, or placebo. In order to evaluate the effects of treatment, the changes of scales and erythema from diagnosis to the end of treatment were scored in psoriatic patients, while changes in itch and erythema were analyzed for erythematous eczema patients. Psoriasis Area Severity Index and Eczema Area and Severity Index scores were also calculated.

RESULTS: In patients with psoriasis, scales and erythema improved both with Bosexil(®) and the V. myrtillus seed oil treatment in comparison with placebo. In particular, the treatment with Bosexil(®) formulation improved scales (70% of cases) and erythema (50% of cases) without any case of worsening. In patients with eczema, the administration of placebo did not result in any improvement in 90% of cases, and in the remaining 10% worsened both itch and erythema. Bosexil(®) formulation improved both itch (60% of cases) and erythema (60% of cases) without any case of worsening. V. myrtillus seed oil improved itch and erythema in 66.7% and 77.8% of patients, respectively.

CONCLUSION: A topical formulation of Bosexil(®) may be promising for the treatment of psoriasis and erythematous eczema. Long-term studies are recommended to evaluate the adherence to this topical treatment and its clinical benefits in real life.

CONTEXT: Boswellia species are trees (family: Bruseraceae) found in India, Northern Africa and the Middle East.

OBJECTIVE: This study aims at formulating low dose biologically active fraction from the oleogum resin of Boswellia carterii (BC) in transdermal (TD) microemulsions (MEs) to acquire promoted anti-inflammatory efficacy.

MATERIALS AND METHODS: The bioactive fraction of the oleogum resin of BC was tested for solubility in different components. The most efficient were selected for constructing phase diagrams for ME preparation. The bioactive fraction was assayed by high performance liquid chromatography for 3-acetyl-11-keto-β-boswellic acid (AKBA), at 210 nm. The bioactive fraction was incorporated in 6 MEs. ME systems were evaluated for drug content and optimized systems were tested for characterization, permeation, skin irritancy and in vivo evaluation of anti-inflammatory activity.

RESULTS AND DISCUSSION: Two systems were selected; ME1 and ME4 composed of Tween 80: PEG 400 at 1:1 and 2:1 ratio, with oil content 7.78 and 17.5%, respectively. The systems showed high encapsulation efficiency >83%, small droplet size <100 nm, and suitable pH for topical application. Permeation parameters for ME1 were higher compared to ME4. Both MEs were non irritant. ME1 showed significantly higher anti-inflammatory activity versus the standard TD anti-inflammatory piroxicam.

CONCLUSIONS: Optimized TD BC MEs could be used as a safe, effective and long acting alternative to oral anti-inflammatories, providing higher and prolonged efficacy and better patient compliance.

Boswellic acids (BAs) are pentacyclic triterpenes extracted from the gum resins of the tropical tree Boswellia serrata. They are orally administered in traditional Indian medicine for the treatment of several inflammatory disease and cancer because of their anti-inflammatory and immunomodulatory activities as well as stimulatory effects on fibroblasts. The present authors have investigated efficacy, tolerability, and safety of a base cream containing 0.5% BAs in the treatment of clinical manifestations of photoaging of facial skin with a randomized, double-blind, placebo-controlled, split-face study. Fifteen female volunteers applied the creams with or without BAs on the half sides of the face once daily for 30 days. Significant improvements of the Dover's global score for photoaging, tactile roughness, and fine lines, as well as, with noninvasive diagnostic techniques, an increase of elasticity, a decrease of sebum excretion, and a change of echographic parameters were observed with topical BAs in comparison with placebo. The treatment was always well tolerated without adverse effects. The present findings seem to indicate that topical application of BAs may represent a suitable treatment option for selected features of skin photoaging.

Boswellic acids (BAs) are pentacyclic triterpenes with strong anti-inflammatory activity; their most important source is the extract of the gum resin of Boswellia serrata, a tropical tree that grows in India and Africa. In the present randomized, double-blind, split-face, comparative study we have assessed efficacy, tolerability, and safety of a base cream containing 0.5 % BAs as compared to the same cream without these active ingredients in the treatment of clinical manifestations of photoaging of facial skin. Fifteen female volunteers were enrolled; they applied creams once daily for 30 days. At baseline, at the end of the treatment, and after a 2-month follow-up, clinical findings were assessed according to the Dover classification scale for photoaging and by biophysical and ecographic measurements. We registered a significant improvement of tactile roughness and fine lines in the half side of the face treated with BAs; noninvasive instrumental diagnostic investigations showed an improvement of elasticity, a decrease of sebum excretion, and a change of echographic parameters suggesting a reshaping of dermal tissue. The treatment was always well tolerated without adverse effects. The present findings seem to indicate that the topical application of BAs may represent a suitable treatment option for selected features of skin photoaging.