Boswellia serrata (Salai/Salai guggul), is an oleo-gum-resin, large-sized branching tree of the family Burseraceae (Genus Boswellia) which grows in dry mountainous regions of India, Northern Africa, and the Middle East [1]. For harvesting, cuts are made in the bark of the tree, once it reaches a certain girth (this requires 8-10 years). The Sap which oozes out hardens to a resin on exposure to air. In India, the States of Andhra Pradesh, Gujarat, Madhya Pradesh, Jharkhand, and Chhattisgarh are the main source of Boswellia serrata. It has been shown to be useful in treating skin-related problems including inflammation, itching, psoriasis, eczema, etc [2]. Boswellia serrata extracted from the Boswellia serrata tree (also known as Indian frankincense, Salai Guggul, Shallaki), which is a part of the Boswellia genus, known for their aromatic resin. Frankincense is one of the oldest commercial commodities, used for more than 5,000 years. Thousands of tons are traded every year to be used as incense in thuribles and by makers of perfumes, natural medicines, and essential oils that can be inhaled or applied to the skin. India is the main producer of B. serrata oleoresin, and exports around 100 MT of the product per annum. The production is mainly from the states of Madhya Pradesh, Andhra Pradesh, Gujarat, Jharkhand, and Chhattisgarh. B. serrata grows primarily in dry forests and rocky hills, with annual precipitation of 50-125 cm [3]. It is mostly procured from trees growing in the wild, although it can be cultivated in a nursery. It flowers between January and April and the seeds mature between May and June. Gum resins like Boswellia can be a good source of income for poor and vulnerable communities and can contribute significantly to poverty alleviation. While Boswellia remains free to harvest, there are general concerns over the sustainability of current farming practices and the risk of overharvesting. This is due to multiple uses and dependencies on such natural produce, which if overharvested could jeopardize livelihoods and species populations. Such effects may also be magnified by other factors, such as climate change, fire, invasive species, or herbivory. Indfrag sources Boswellia Gum from Madhya Pradesh (Central India). To improve the raw material ecosystem and traceability, Indfrag opted to implement Fair Trade practices for Boswellia sourcing. FAIRTRADE is a global organization and the most trusted sustainability label in the world which improves ethical practices across supply chains and FLOCERT is the global certifier for FAIRTRADE. Thus, the supply chain for Boswellia serrata is Fairtrade Certified and involves transactions directly from a producer group by removing the middlemen. There are more than 400 beneficiaries who collect Boswellia from the forests. This certification helps them to understand about how to sustainably harvest/collect the material with continuous trainings. Apart from this, they also do plantations which is indirectly helping them for the future as well as generating resources. Boswellia is best known for its anti-inflammatory properties which show positive results against skin irritation [4]. Inflammation usually occurs when infectious microorganisms such as bacteria, viruses, or fungi invade the body, reside in particular tissues, and/or circulate in the blood [5]. It may also happen in response to processes such as tissue injury, cell death, cancer, ischemia, and degeneration [6]. The gum resin of B. serrata has been also found effective in curing diverse skin problems such as psoriasis, and eczema [7]. A double-blinded, randomized, monocentric placebo-controlled study was conducted to evaluate the safety and efficacy of the test product in imparting relief from inflammation in patients with mild to moderate eczema and psoriasis. The purpose of the study was to validate the benefits of the test products in reducing skin inflammation with regular use over a period of 6 weeks in comparison to the baseline and placebo. The study also aimed at evaluating the tolerability of the test products.

Study Population

The study was conducted on 71 male and female subjects aged between 25-and 55 years (both ages inclusive) with sensitive skin types showing signs of itching, irritable, and/or inflamed skin. Furthermore, the subjects with inflamed skin conditions such as mild to moderate eczema and psoriasis were enrolled in the study.

There were two groups in the study – Group 1 and Group 2

Group 1: Test Product containing Boswellia serrata (N = 35)

Group 2: Placebo (N = 36)

Clinical Study Design

The study was a randomized, double-blinded, monocentric study conducted at MS Clinical Research, Bengaluru, India. The study protocol was approved by the Ethics Committee and written informed consent was obtained as per the ICH-GCP guidelines before the participation. The benefits of the test product were evaluated by dermatological visual evaluation, self-assessments, spectrophotometer, and imaging at day 1 (baseline) D14, D28, and D42.

Dermatological Visual Assessment

Subjects were clinically evaluated based on visual assessment for skin inflammation (erythema, edema, population, induration, dryness, and excoriation). The subjects were also scored for itch by subject interview.

Spectrophotometer Measurement

The instrumental evaluation was done using a CM-2600d Spectrophotometer, to assess skin color in terms of skin redness associated with skin inflammation.

Subject Self-Assessment

Subject self-assessment based on sensorial aspects such as dryness, burning sensation, peeling/scaling, tingling, and warmth was assessed on a severity scale (0-4), where 0 was none and 4 was the most severe case.

Imaging

Standard Digital Images were taken for photographic records.

Dermatological Visual Assessment

Skin inflammation was calculated by taking an average of Erythema, Oedema, Population, Induration, Dryness, and Excoriation. Itch score, on the other hand, was determined by a 0-10 scale, where 0 resulted in no itch and 10 resulted in unbearable itch. This was done based on the subject’s perception, under the supervision of the dermatologist. With regular usage of the test product, there was a significant reduction in skin inflammation from 13.74 on baseline visit to 3.71, at the end of the study in comparison to the placebo; the efficacy (reduction in inflammation) was significantly higher by the end of the study. Itch score also showed a similar pattern of reduction in the degree of itch, from baseline to day 42. A reduction in mean values depicted a reduction in inflammation and itch scores (Figure 1, 2).

  Figure 1: Skin inflammation. A lower value is a sign of improvement of lower skin inflammation.

            Figure 2: Itch Score. A lower value is a sign of improvement of lower itch.

Instrument Assessment

CM-2600d Spectrophotometer measurement is based on the absorption and reflectance of light from the surface. The degree of skin redness was determined using a* value. It was observed that the mean values for lesion and non-lesion inflammation reduced over time from baseline to week 6, for the test product group when compared with placebo in (Figure 3). When the difference between lesional and non-lesional inflammation was observed in (Figure 4).

Figure 3: Mean values of a*-lesional and non-lesional at different time points. A lower value indicated lesser erythema.

Figure 4: Mean values of ?a* (Difference between non-lesional and lesional) at different time points.

Which is given by ?a*, it was seen that with test product application, the mean values increased, showing a reduction in the inflammation (from -0.61 to 0.36). Another parameter tested using a spectrophotometer, was the difference in color between lesional and non-lesional regions. This was determined by ? color. A significant decrease in mean values over the study duration was observed, inferring the reduction in skin inflammation and improvement in skin color with the application of test product containing B. serrata, as seen in (Figure 5).

Figure 5: Mean values of ? Color (Difference between lesional and non-lesional) at different time points. A lower mean value indicates improvement in skin color i.e., lower the difference between the lesion and non-lesionalbetter improvement in skin color.

Subject Self-Assessment

Test product containing B. serrata showed a reduction in redness from baseline. About 68.57% of subjects had severe redness, leading to an improvement of about 71.43% of subjects having no redness at the end of the study. A similar pattern was seen with the parameter of dryness and burning sensation, where 60% of the total population with a severe case of dryness and burning sensation at baseline, after the application of B. serrata for 6 weeks, resulted in an improvement of about 14.29% and 62.86% subjects, with no dryness and burning sensation respectively. Parameters for peeling/scaling, tingling, and warmth were assessed. About 57.14% of the population with very severe cases of peeling/scaling and an equal percentage with a severe case of tingling showed improvement by the end of the study. A similar pattern was seen for the warmth parameter, with an improvement from 77.14% at baseline to 42.86% at visit 4. The test product when compared to the placebo, showed improvement in reducing dryness, redness, burning sensation, peeling/scaling, tingling, and warmth by the end of the study. Based on subject feedback, collected on day 14, day 28, and day 42, it was observed that the entire test population completely agreed that the test product gave relief from skin irritations and reactions and had a soothing effect. The 6-week study conducted among 71 men and women indicated that the test product containing B. serrate showed a greater potential than the placebo at reducing skin redness, inflammation, dryness, burning sensation, peeling/tingling, and other reactions when compared to the baseline. The treatment effect was noted to be similar between the age groups and sexes (Figure 6, 7).

Test Product Conataining Boswellia Serrata

Figure 6: Pictures of subjects having different stages of psoriasis and eczema showing significant improvement on treatment with B. serrata containing test product at different time points from baseline to week-6.

Placebo Controlled Group

Figure 7: Pictures of subjects having different stages of psoriasis and eczema showing no significant improvement on treatment with placebo at different time points from baseline to week-6.

Skin inflammation as seen in eczema, psoriasis, etc is a disease with complex pathogenic interactions between innate and adaptive immunity. The study is designed for the relief of symptoms like itching, dryness, redness, peeling/ scaling, burning sensation, tingling, and warmth in lesion regions [9]. The resinous part of B. serrata contains alpha- thujene, incensole, incensole oxide, iso-incensole oxide, serratol, boswellic acids as the main constituents which help in its anti-inflammatory, immune modulatory, antitumor properties. Boswellic acids found in Boswellia serrata also help in the inhibition of 5-lipoxygenase, which cascades in the activation of the MAPK signaling pathway [4]. Results of the 6-week study showed that the B. serrata containing test product improved skin lesions of patients with eczema and psoriasis. Further studies and research are recommended to understand the potential adjunctive benefits of B. serrata as a topical therapy for eczema, psoriasis, and other inflammatory skin conditions.

1. Sharma A, Bhatia S, Kharya MD, Gajbhiye V, Namdeo AG, Ganesh N, et al. Anti-inflammatory and analgesic activity of different fractions of Boswellia serrate: International Journal of Phytomedicine. 2010; 94-99.
2. Togni S, Maramaldi G, Pierro FD, Biondi MA. cosmeceutical formulation based on boswellic acids for the treatment of erythematous eczema and psoriasis: Clinical, Cosmetic and Investigational Dermatology. 2014; 321-327
3. Fobar R. Frankincense trees of biblical lore are being tapped out for essential oils: National Geographic. 2019.
4. Siddiqui MZ. Boswellia serrata a potential antiinflammatory agent: an overview: Indian journal of pharmaceutical sciences. 2011; 73: 255-261.
5. Azab A, Nassar A, Azab AN. Anti-Inflammatory Activity of Natural Products: Molecules. 2016; 21: 1321.
6. 6. Lucas SM, Rothwell NJ, Gibson RM. The role of inflammation in CNS injury and disease: Br J Pharmacol. 2006; 147: S232-S240.
7. Roy NK, Parama D, Banik K, Bardoloi D, Devi AK, Thakur KK, et al. An Update on Pharmacological Potential of Boswellic Acids against Chronic Diseases: International journal of molecular sciences. 2019; 20: 4101.
8. KA, Garay M, Nebus J, Chon S, Kaur S, Mahmood K, et al. Anti-Inflammatory Acitivities of Colloidal Oatmeal (Avena sativa) Contribute to the effectiveness of Oats in Treatment of itch associated with dry, irritated skin. Journal of Drugs in Dermatology. 2015; 14: 43-45.
9. Bonesi M, Loizzo MR, Provenzano E, Menichini F, Tundis R. Anti-Psoriasis Agents from Natural Plant sources. Current Medicinal Chemistry. 2016; 23: 1250-1267.