|Grade||Level of Evidence|
|A||Multiple double-blind, controlled clinical trials.|
|B||1 double-blind, controlled clinical trial.|
|C||At least 1 controlled or comparative clinical trial.|
|D||Uncontrolled, observational, animal or in-vitro studies only.|
|Grade||Effect||Size of Effect||Comments|
Helps store water in the skin and reduces water loss. Effective in improving xerosis.
Reduces the risk of neonatal dermatitis when used with olive oil. Helps prevent nickel contact dermatitis.
Enhances the epithelialization rate of wounds. Cured acute anal fissures in 93% of children in one study.
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Table of contents:
Lanolin is a yellow ointment-like material comprising a complex mixture of esters, alcohols, sterols, fatty acids and hydrocarbons. It is produced by the sebaceous glands of sheep to soften fleece and to protect it against the elements. Because it is isolated from sheared wool, it is also called wool wax or wool grease. Although historically it is also often referred to as wool fat, this is not technically true since lanolin does not contain glycerides.
Lanolin has been applied to human skin since Egyptian times, but the term was coined by Otto Braun, a German who in 1882 patented a method for centrifuging the scouring liquid derived from wool washings. Soon after this discovery, the large-scale production of lanolin began in Germany and spread to the United Kingdom. By the end of the nineteenth century, lanolin was produced in most European countries.
Lanolin was first presented as a basis for salves and ointments in 1866. It was favoured for its non-irritancy to the skin, and was prescribed by dermatologists for treating skin conditions such as chapped hands, eczema, acne and psoriasis.
In cosmetics, lanolin functions as an emollient, an emulsifier, a skin and hair conditioner, an anti-static agent and as a surfactant. A survey of 256 commercially available moisturizers in 2008 found that lanolin was present in 10% of the products.
Many of the earliest published papers on lanolin noted the ease and rapidity with which it was absorbed into the skin. These papers however relied largely on anecdotes, which would not qualify as scientific evidence by modern standards.
More recent experiments show that most topically applied lanolin reside in the stratum corneum, but that trace amounts penetrate via intercellular spaces down as far as the stratum lucidum, the clear layer of dead skin cells located between the stratum corneum and the stratum granulosum. Corneocytes also appear to be permeable to lanolin, which seems to become incorporated in the lipid bilayers of cell membranes as well as to penetrate into the cells' interior.
Lanolin seems to alter the penetration of certain substances. Although it did not have any effect on the skin permeability to calcipotriol and betamethasone dipropionate ointments, it has been observed to increase the penetration of salicylic acid, and to reduce the absorption of nickel.
3. Effects on the skin
3.1 Increased moisturization
Lanolin is hygroscopic; a sample of anhydrous lanolin must absorb at least 200% its own weight in water to be considered of acceptable quality. It is not however considered a humectant, but as an occlusive and as an emollient.
Lanolin's hydrating effect has been tested on xerotic skin. Pure lanolin was as effective as a 12% ammonium lactate cream in relieving moderate to severe xerosis of the foot in a double-blind clinical trial of 92 patients. When lanolin was compared to petrolatum, mineral oil, olive oil, a commercial hand cream and a commercial face cream for its efficacy in treating mild to moderate winter xerosis of the legs in 10 women, it was second only to petrolatum, producing a 2-grade improvement in xerosis severity after 3 weeks. The water present in the hydrous lanolin was not responsible for the increased hydration, as repeated immersion of dry legs in water for 2 weeks had no effect in alleviating xerosis. Neither was it due to its greasy nature, as mineral oil and olive oil did not result in significant moisturization.
Instead, lanolin has a semi-occlusive nature, causing moisture in the skin to build up by an additional 10-30% via retarding transepidermal water loss (TEWL). It is less effective as an occlusive than petrolatum, as evidenced by a study where lanolin applied to the inner surface of the forearm led to a 32% reduction in moisture loss from the skin, lower than the 48% reduction observed for petrolatum under the same conditions. Another mechanism through which lanolin achieves its moisturizing action may be that it spontaneously forms emulsions with water that moves through the intercellular spaces of the stratum corneum, thereby creating an additional reservoir of water.
3.2 Dermatitis treatment
Lanolin has been employed in the treatment of eczema or dermatitis since the late 19th century, when its potential as a base for ointments and salves was first delineated. Contemporary research supports this usage, finding that lanolin's soothing and hydrating properties make it a valuable ingredient for managing eczema and other dry skin conditions.
A randomized controlled trial of 173 infants admitted to a neonatal intensive care unit revealed that a cream consisting of 70% lanolin + 30% olive oil lowered the risk of dermatitis more than a commercial emollient cream (Bepanthen Nappy Care Ointment) after 4 weeks of treatment.
3.3 Soothes nipples
Topical lanolin has been compared with the use of expressed breast milk to relieve nipple pain, with mixed results. One study found no significant differences in their effects on pain intensity or pain affect, another concluded that hind milk led to better healing of sore nipples, and a third revealed that highly purified anhydrous lanolin (probably Lansinoh HPA Lanolin) both reduced nipple pain and induced faster healing of nipple trauma.
The combined use of lanolin cream and breast shells also led to greater healing and less pain than the use of wound dressings, in addition to a lower rate of infections in a randomized controlled trial of 42 women. However, a separate study had the opposite results, finding that a lanolin ointment was less effective than hydrogel dressings at pain reduction and was associated with more breast infections.
Lanolin was also as effective as warm water compresses, glycerin gel therapy, and an all-purpose nipple ointment, but less effective than a peppermint gel and less preferred to an olive oil ointment in this respect.
Overall, while an earlier systematic review concluded that no one topical agent was superior in relieving nipple discomfort in breastfeeding mothers, a more current review indicated that the use of lanolin alone or with breast protection shells and the use of expressed breast milk had the most favourable evidence in treating nipple trauma.
3.4 Improved healing
Lanolin cream and dressings have been shown to significantly enhance the epithelization rate in the healing of partial-thickness and split-thickness wounds of piglets, compared to a control gauze and inert dressings. It has been hypothesized that lanolin's healing action may be through inducing inflammatory reactions and activating cells such as macrophages and fibroblasts that produce growth factors and other mediators of the repair process.
Mixtures of lanolin and petrolatum are often used as controls in studies of the healing of diabetic and cutaneous wounds in rats. These studies indicate that it is less effective than topical atorvastatin or nebivolol, and that its healing efficacy is enhanced with the addition of 5% aroeira oil.
Moreover, a topical lanolin ointment (Medela PureLan) completely healed 93% of children with acute anal fissures in a randomized clinical trial, compared to 68% of children in the control group. A prospective case series also found that an Amish burn wound ointment (B&W Ointment), which contains lanolin, appeared to be an acceptable herbal remedy to conventional burn care in 5 Amish patients with first- and second-degree burns when used in combination with burdock leaves. However, this cannot be construed as evidence for the healing effect of lanolin, because the B&W ointment also contains many other natural components that are known to aid healing, such as honey, aloe vera, comfrey root, wormwood and glycerin. It has also been suggested that caution should be taken in the use of Amish burn wound ointment and burdock leaf dressings if there is more than a minimal risk of complications from a burn injury, since aqueous extracts of dry ingredients used in the ointment as well as burdock leaf have demonstrable inhibitory effects on the growth of keratinocytes and fibroblasts in vitro.
3.5 Other effects and uses
It is not clear if topical lanolin increases or decreases the incidence of skin infections. A lanolin-based gel seemed to offer mechanical protection against the transmission of viral particles between filter discs in one experiment, but treatment with lanolin cream appeared to be associated with skin infection in colloidon babies in another study. A randomized controlled trial comparing sunflower seed oil and Aquaphor Original Ointment, which contains petrolatum, mineral oil, mineral wax and lanolin alcohol found that the preterm infants who received daily massages with sunflower seed oil were better protected against nosocomial infections than those who received massages with the Aquaphor ointment.
There has been one case of a patient with miliaria profunda who responded to therapy with anhydrous lanolin and isotretinoin. Lanolin was also helpful in attenuating lip dryness in patients undergoing chemotherapy.
4. Side Effects
The safety of lanolin and its derivatives was first evaluated by the Cosmetic Ingredient Review Expert Panel in 1980. Their original assessment stated that lanolin, lanolin oil, lanolin wax, lanolin alcohol, acetylated lanolin, acetylated lanolin alcohol, hydrogenated lanolin and hydroxylated lanolin were safe for topical application to humans, a conclusion that was upheld in a 2003 re-review.
4.1 Adverse skin reactions
Lanolin and its derivatives were mostly non-irritating or at most mildly irritating to the skin of experimental animals, with the exception of lanolin acid, which is rarely found in cosmetic formulations as the free acid. Hydrogenated lanolin did not sensitize the skin of guinea pigs either, though lanolin wax suspended in corn oil was mildly sensitizing.
Nevertheless, lanolin has a reputation for being an important contact sensitizer. Contact hypersensitivity and allergic reactions to lanolin are well-documented, including those in topical medications or bandages and cosmetics.
Patch tests of patients with suspected allergic contact dermatitis in the Americas indicate that the prevalence of lanolin sensitivity in North America (as measured by patch tests to 30% lanolin alcohol in petrolatum) was 3.7% in the late 1990s but has since declined to about 1.8% to 2.5%. In Brazil, the frequency averaged 2.59% from 2006-2011, but showed a statistically significant decline through this period.
Patch test data from Europe is also available. According to results collected by the Information Network of Departments of Dermatology in Germany, lanolin alcohol was among the top allergens from 1995-2007, and positive patch test reactions to lanolin alcohol were more common in women (3%) than men (2.2%). From 1982-1996, the mean annual rate of sensitivity to lanolin was 1.7% in England, compared to 3% in the Czech Republic from 1997-2001. The rate of sensitization to lanolin alcohol was 3.6% among 4,094 patients tested at the Zurich University Hospital in Switzerland from 2000-2004.
In Asia, lanolin was also one of the commonest contactants causing allergic contact dermatitis in Singapore in 1989, accounting for 6.5% of positive patch test reactions, putting it on par with colophony and behind only nickel (20.8%), fragrances (12.3%) and neomycin (7.1%).
Some dermatologists have dismissed the idea that lanolin is a major sensitizer. In the 1980s, Kligman recruited 943 women with no history of skin problems to undergo patch testing with hydrous lanolin, Eucerin, and 30% wool alcohols in petrolatum, and found zero positive patch-test results, leading to his conclusion that lanolin is a weak sensitizer. He proposed that previously reported high prevalence rates were due to false-positive results, either from poor interpretation of patch tests or from hyper-reactive skin.
The term 'lanolin paradox' refers to this and other puzzling clinical phenomena related to the use of lanolin: (1) lanolin in topical medicaments sensitizes a high proportion of certain patients, but is safe in cosmetics widely used by millions of individuals; (2) patients with allergic contact dermatitis to lanolin in medications applied to ulcerated skin do not develop reactions to lanolin-containing cosmetics; and (3) lanolin-sensitive patients often have negative patch-test reactions to pure lanolin. Regarding the first and second paradoxes, it has been reasoned that lanolin is a weak sensitizer in normal skin, whereas damaged skin is easily sensitized. As for the third paradox, this may be due to a low concentration of allergens in some lanolin preparations, or because patch testing with 30% lanolin alcohols is simply an unreliable method for detecting and confirming lanolin allergies. For instance, some studies have shown that the reproducibility of positive reactions to lanolin is rather poor. Edman and Moller found that only 20 of 33 patients with documented positive patch-test reactions to lanolin had positive reactions upon repeat testing, and Carmichael and colleagues reported a year later that of 37 patients with prior positive patch-test reactions to lanolin, only 41% retained their sensitivity when retested 5 years later.
While the incidence of lanolin allergy in the general population is very low (estimated to be no more than 9.7 cases per million people, or 0.00097%), it is undeniable that selected populations are at higher risk. Contact allergy to topical medicaments in general is known to become more common with advancing age. Lanolin and lanolin alcohols have shown increased sensitization rates in elderly patients compared with adult patients in 2 studies, which is thought to be due to age-related immunosenescence and confounding co-morbidities such as dry skin and dermatitis.
Patients with leg ulcers, which are a symptom of lower-extremity venous stasis dermatitis, have also been identified as a high-risk population for the development of contact dermatitis from lanolin. They have a very high rate of contact allergy, and lanolin has consistently been found to be among the most frequent culprits of positive patch tests in such patients since the 1980s.
Atopic patients, on the contrary, may or may not be more vulnerable to lanolin allergy. An early study evaluating contact dermatitis in atopic patients reported that out of 80 men and 153 women, only 1% of both groups had positive reactions to 30% wool alcohols, compared to 11% of men and 20% of women with stasis dermatitis. Another study testing 73 adult patients attending a clinic for atopic dermatitis reported that 4 (5.5%) were patch-test positive for lanolin.
Allergic contact dermatitis to lanolin also seems to be common in childhood. A retrospective case study of 114 children who were patch tested at a children's hospital in Glasgow revealed that 4.5% of the positive reactions were to lanolin. In a prospective study of 137 pediatric patients with atopic dermatitis in France, 43% of the children demonstrated contact sensitization and lanolin accounted for 4.4% of the positive reactions. Another study of 424 Norwegian schoolchildren, 1.7% of the 144 positive tests were for lanolin. Lanolin was also one of the most frequent allergens among patch-tested children in the US and Canada, with data from the North American Contact Dermatitis Group over the period 2001-2004 indicating that children aged between 6-12 years are the most susceptible. Similarly, out of 2,340 children and adolescents in Singapore who underwent patch testing from 1986-2003, there were 1,063 positive reactions, of which lanolin accounted for 8%. The exception was a study on 9,320 Polish children, none of which tested positive to lanolin.
Interestingly, there is evidence of a genetic basis for sensitization to lanolin. Significantly more patients with loss-of-function mutations in the filaggrin gene (FLG) were found to be sensitized to lanolin than wild-type subjects, possibly because this mutation is associated with reduced skin barrier function, which may allow for increased penetration of lanolin. However, it is not clear if genetic differences underlie the higher rates of lanolin sensitization that have been observed in white versus black patients, and in women versus men.
Climatic conditions are also known to be linked to patch test results for lanolin alcohol. Specifically, there is a weak inverse association between dry/cold weather and positive reactions to lanolin.
The natural fatty alcohols, sterols and cholesterol present in lanolin are thought to be responsible for its allergenicity.  Reducing the free alcohol content in lanolin has been shown to dramatically reduce the incidence of positive patch test reactions amongst lanolin-sensitive skin patients.
Medical-grade lanolins such as Medilan are much less antigenic than less purified forms of lanolin. In a study of 27 patients sensitive to Amerchol L 101, a product containing lanolin alcohols, only one (3.7%) reacted to Medilan. Another study tested 24 atopic individuals, 12 patients with varicose eczema or leg ulcers, 50 patients with chronic leg ulcers and 6 patients who had been previously classified as lanolin sensitive. None of the patients reacted to any of 4 Medilan preparations.
4.2 Photosensitivity and phototoxicity
2 product formulations each containing 0.75% lanolin acid, 3.0% lanolin alcohol and 0.5% hydroxylated lanolin have been tested by the Cosmetics Toiletry and Fragrance Association (CTFA) Task Force on Cosmetics for phototoxicity on 20 human subjects and for photosensitization on 25 human subjects. Neither formulation displayed evidence of phototoxicity or photosensitivity.
Anhydrous lanolin, lanolin oil, lanolin wax and acetylated lanolin are at most only mildly comedogenic, producing no or only a slight increase in follicular keratosis in rabbit ear skin. Acetylated lanolin alcohol and PEG 16 lanolin are strongly comedogenic however.
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