Bio-Oil clinical research

Bio-Oil clinical research

Whilst, as a cosmetic product, Bio-Oil is not required to carry out clinical research, a number of studies and trials have been commissioned to test the efficacy of Bio-Oil on stretch mark treatment and scar treatment across different skin types, and to determine its suitability for sensitive skin. Below is summary of the research findings.

Scarring

Exploratory study, Dept. of Dermatology, Peking University First Hospital, Beijing, China

Efficacy of Bio Oil in improving the appearance of facial acne scars on Chinese subjects, 2012.

Objective: Assess the efficacy of Bio-Oil in improving the appearance of facial acne scars on Chinese subjects.

Sample: 44 Chinese subjects with newly formed acne scars on the face (-1 year old). Bio-Oil treatment cell included 32 subjects and the no treatment cell included 12 subjects. Age of participants: 14 to 30.

Methodology: Randomised, controlled, efficacy grader-blinded. Subjects participated in an initial screening evaluation followed by a 1-week washout period. Product applied twice daily for 10 weeks. Application performed under supervision at regular intervals. Assessments conducted at 0, 4, 8 and 10 weeks included the following: Global scarring score (GSS) assessment by the investigator, measurement of acne scar colour / redness using a chromameter, measurement of sebum levels using a sebumeter, documentation of number of comedones and inflammatory lesions by a dermatologist. Subjects also completed self-assessment questionnaires at each visit.

Result: The best result of the clinical grading was in Bio Oil’s ability to reduce the erythema or redness of macular (flat) acne scars, with the overall skin becoming brighter. Results of the self-assessment questionnaire showed that more than 84% of subjects experienced an improvement in the overall condition of their acne scars and more than 90% experienced an improvement in scar colour. Acne count and sebum measurement results showed that using Bio-Oil does not cause or aggravate acne, or increase sebum secretion.

User trial summary, Ayton-Moon, Somerset, UK 2002

Ability of Bio-Oil to improve the appearance of scar tissue, in a user trial.

Objective: To rate the ability of Bio-Oil to improve the appearance of scars, in an 82-person user trial.

Sample: 82 participants including adults and children. Scar ages: newly formed to older than 10 years. Scar types: raised, flat and depressed scars, ranging from minor burns and grazes to surgical scars.

Methodology: Product was applied three times daily for four weeks. Participants instructed to massage in a circular motion until product fully absorbed. Interviews conducted at 0, 2 and 4 weeks. Participants rated the improvement they noticed on a scale from 1 – 9 (1 representing ‘no improvement’ and 9 representing ‘much improvement’).

Result: 82% of participants recorded an improvement in the appearance of their scars after four weeks.

Photobiology Laboratory of the Medical University of South Africa, 2005

Efficacy of Bio-Oil in improving the appearance of scars.

Objective: To assess the efficacy of Bio-Oil in improving the appearance of scars.

Sample: 24 participants (22 female and two male) aged 18 to 60. Scar ages: newly formed to three years old. Scar types: range from minor burns to surgical scars (12 major scars, 14 minor scars – one participant had three scar sites).

Methodology: Single-blind (assessor), randomised and controlled. Paired study design allowing for intra-subject comparison. Subjects had matching scars or a scar large enough to allow application to half a scar. Product applied twice daily for 12 weeks to the targeted area. Application performed under supervision at regular intervals. Assessments conducted at 0, 4, 8 and 12 weeks.

Result: Bio-Oil improved the appearance of scars in both objective and subjective assessments. 65% of subjects recorded an improvement in appearance at four weeks.

proDERM institute for applied dermatological research, Hamburg, Germany, 2010

Efficacy of Bio-Oil in improving the appearance of scars.

Objective: To assess the efficacy of Bio-Oil in improving the appearance of scars.

Sample: 36 female participants of varying ethnicities and aged 18 to 65. Scar ages: newly formed to three years old. Scar locations: abdomen, leg, arm, neck, knee, trunk, upper body.

Methodology: Double-blind, randomised, parallel group. Subjects had matching scars or a scar large enough to allow a half-half scar application and intra-subject comparison. Product applied twice daily for eight weeks, no additional massaging performed on the target area. Application performed under supervision at regular intervals. Assessments conducted at 0, 2, 4 and 8 weeks. Different scar parameters as defined in the Patient and Observer Scar Assessment Scale (POSAS) were evaluated.

Result: Bio-Oil is efficacious in improving the appearance of scars. A statistically significant result was shown after only two weeks (day 15), evident in 66% of the subjects. After eight weeks (day 57), 92% of subjects showed an improvement, with the extent of the improvement almost triple that at two weeks. A continuous improvement of POSAS over the duration of the study.

Striae (stretch marks)

Photobiology Laboratory of the Medical University of South Africa, 2005.

Efficacy of Bio-Oil in improving the appearance of stretch marks.

Objective: To assess the efficacy of Bio-Oil in improving the appearance of stretch marks.

Sample: 20 female participants aged: 18 to 55. Stretch mark location: abdomen.

Methodology: Single-blind (assessor), randomised and controlled. Paired study design allowing for intra-subject comparison. Subjects had bilateral abdominal stretch marks, enabling half-abdomen study design. Product applied twice daily for 12 weeks to the targeted area. Application performed under supervision at regular intervals. Assessments conducted at 0, 4, 8 and 12 weeks.

Result: Bio-Oil improved the appearance of stretch marks in both objective and subjective assessments. 50% of subjects recorded an improvement in appearance at eight weeks.

proDERM institute for applied dermatological research, Hamburg, Germany, 2010.

Efficacy of Bio-Oil in improving the appearance of stretch marks.

Objective: To assess the efficacy of Bio-Oil in improving the appearance of stretch marks.

Sample: 38 female participants of varying ethnicities and aged 18 to 65. Stretch mark causes: various (post pregnancy, weight gain or adolescent growth spurt). Stretch mark locations: abdomen, thigh and hips.

Methodology: Double-blind, randomised and parallel group. Subjects had matching stretch marks or a stretch mark large enough to allow a half-half stretch mark application and intra-subject comparison. Product was applied twice daily for eight weeks, no additional massaging performed on the target area. Application performed under supervision at regular intervals. Assessments conducted at 0, 2, 4 and 8 weeks. Different scar parameters as defined in the Patient and Observer Scar Assessment Scale (POSAS) were evaluated.

Result: Bio-Oil is efficacious in improving the appearance of stretch marks. A statistically significant result was shown after only two weeks (day 15), evident in 95% of the subjects. After eight weeks (day 57), 100% of subjects showed an improvement, with the extent of the improvement more than double that at two weeks. A continuous improvement of POSAS over the duration of the study.

Other

Future Cosmetics, Pretoria, South Africa, 2006.

Risk of acne and comedones (pimples) with Bio-Oil.

Objective: To test whether Bio-Oil is likely to cause acne and comedones (pimples).

Sample: 21 participants (17 female and four male of varying ethnicities), 50% prone to acne.

Methodology: Randomised and controlled. Product applied twice daily for 28 days. Three areas evaluated: untreated area (negative control), area to which Bio-Oil was applied, and area to which acetylated lanolin alcohol was applied (positive control – a known acnegenic product). Test products applied to the upper back (scapular) region.

Result: Bio-Oil was found to be non-acnegenic and non-comedogenic. Area to which Bio-Oil was applied showed no significant difference to the untreated area. Positive control induced acne.

Dr. J Wiechers at Rigano Laboratories, Milan, Italy, 2008.

Identifying occlusivity level of Bio-Oil. Prof.

Objective: To evaluate whether Bio-Oil demonstrates a similar occlusivity level to vernix caseosa. (Vernix caseosa, the creamy-white and viscous biofilm that envelopes a baby while it is in the womb, is widely considered by cosmetic scientists as the ‘gold standard’ in skin moisturisation because of its ideal occlusivity level.)

Methodology: Known quantities of water were placed in beakers covered with a semi-permeable membrane called Vitro-Skin™, which mimics the surface properties of human skin. Vernix caseosa and Bio-Oil were applied to the membrane and the rate of water loss from the beaker was measured over time. This was compared with the rate of water loss without any product on the membrane. The water vapour transfer rate for each product was calculated and expressed in g/m2/h.

Result: Bio-Oil demonstrated a very similar occlusivity level to vernix caseosa, with Bio-Oil registering 23.5 and vernix caseosa 27.2.

Thomas J. Stephens & Associates, Inc., Texas, United States of America. 2011.

Efficacy of Bio-Oil in improving uneven skin tone and mottled pigmentation.

Objective: To evaluate the efficacy of Bio-Oil in improving the appearance of uneven skin tone and mottled pigmentation when used by women with mild to moderate photodamaged (aging) skin on the face and neck.

Sample: 67 female participants (of varying ethnicities) with clinically determined mild to moderate photodamage on the face and neck. Bio-Oil treatment cell included 35 subjects and the no treatment cell included 32 subjects. Age of participants: 30 to 70.

Methodology: Randomised, controlled, efficacy grader-blinded. Subjects participated in an initial screening evaluation followed by a one-week washout period. Product applied to the face and neck twice daily for 12 weeks. Application performed under supervision at baseline visit. Clinical evaluations conducted at 0, 2, 4, 8 and 12 weeks. Subjects were clinically graded separately on the face and neck for uneven skin tone and mottled pigmentation.

Result: Bio-Oil is efficacious in improving the appearance of uneven skin tone and mottled pigmentation in photodamaged (aging) skin. After four weeks, a statistically significant result was achieved for both parameters on the face and neck. After 12 weeks, 86% of subjects in the Bio-Oil treatment cell showed a statistically significant improvement in uneven skin tone on the face, 71% of subjects in mottled pigmentation on the face, 69% in uneven skin tone on the neck.

Photobiology Laboratory of the Medical University of South Africa. 2011.

Efficacy of Bio-Oil in improving stratum corneum (SC) barrier function and hydration in a single application.

Study 1

Objective: To assess the effect of a single application of Bio-Oil to improve stratum corneum (SC) barrier function and hydration.

Sample: 40 female participants of varying ethnicities. Test site: test products applied to the volar forearm of all subjects.

Methodology: Assessment of skin hydration with a Corneometer as the primary measure, assessment of barrier function with a Vapometer as a secondary measure. Panelists washed their forearms with soap 2 hours before measurements were taken. Baseline instrumental measurements were taken. Bio-Oil and a reference oil were then applied to separate sites on the volar forearm of all subjects. Measurements were taken again immediately after product application as well as 2 hours later, before and after wiping the products off. A control untreated site was also measured at all time points.

Result: After immediate application, both oils reduced transepidermal water loss (TEWL) compared to the no treatment control. Increased skin capacitance values at the 2-hour pre-wipe time point indicated increased skin hydration for both oils. Two hours later, after wiping the oils from the skin’s surface, Bio-Oil showed further increased TEWL values compared to the reference oil, indicating increased moisture release and therefore increased skin hydration.

Study 2

Objective: To assess the effect of twice daily application of Bio-Oil for moisturisation performance and relief of dry skin.

Sample: 25 female Caucasian participants. Test site: test products applied to the outer, lower leg of all subjects.

Methodology: Soap was used to induce dry skin over a seven-day period. Bio-Oil and a reference oil were applied twice daily. Skin assessments were made on days one and three. Visual evaluations were performed by a trained visual evaluator using a 2x magnifying lamp. A control untreated site was also evaluated at all time points.

Result: Both Bio-Oil and the reference oil improved skin dryness compared with the no treatment control. Bio-Oil was statistically superior on day three. Significant improvements in visual appearance of skin sites treated with Bio-Oil confirmed its effectiveness in relieving dry skin.


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