Clinical trials

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

Objective
To assess the moisturising efficacy of Bio-Oil Dry Skin Gel.

Sample
Subjects: 28 female particpants (of whom 1 with Fitzpatrick skin type I, 13 with skin type II and 14 with skin type III). Age of participants: 29 to 65.

Methodology
Split-body, evaluator-blinded, randomised, controlled clinical trial. A one-week dry down period was followed by a two-week treatment period and a three-day regression period. During the two-week treatment period subjects applied Bio-Oil Dry Skin Gel to the assigned lower leg, the opposite leg remained untreated. Clinical evaluations were conducted at baseline and days 2, 4, 7, 9, 11 and 14 and on regression days 1, 2 and 3. Subjects were clinically graded for dryness (on a scale from 0 – 5). Bioinstrumentation measurement of skin hydration was by using Corneometer and SKICON. Bioinstrumentation measurement of transepidermal water loss (TEWL), as an indicator of barrier function, was by using Tewameter.

Result
Compared to the untreated side, Bio-Oil Dry Skin Gel showed statistically significant improvements in clinical grading of dryness, using SKICON measurements and Corneometer measurements, at all time points; and in Tewameter measurements, at treatment day 14 and regression day 3. For clinical grading of dryness statistically significant improvements were evident in 82% of subjects after only two days. After two weeks 100% of subjects showed a statistically significant result, with the extent of the improvement almost triple that at day 2. Three days after treatment was stopped 93% of subjects had maintained a statistically significant improvement compared to the start of the study.

Trial centre
Ayton Global Research, Somerset, United Kingdom.

Objective
To assess the performance of Bio-Oil Dry Skin Gel in the alleviation of dry skin on the body, in a 102-person user trial.

Sample
Subjects: 102 female participants with self-assessed “Very Dry” skin on the body. Age of participants: 18 and over.

Methodology
A two-week, single-placement, in-home user trial. Participants were instructed to apply product daily to clean, dry skin. Two short questionnaires were completed: the first after initial application and the second after two weeks of using the product.

Result
Application:

• 94% of participants agreed that “the product is easy to apply”.
• 96% of participants agreed that “a little goes a long way”.

• 83% of participants agreed that “the product absorbs easily into the skin”

• 92% of participants agreed that “the product leaves skin feeling immediately moisturised”
• 80% of participants agreed “their skin felt moisturised throughout the day”
• 86% of participants agreed that “their dry skin improved over the course of the two-week period”
• 85% of participants agreed that “their skin looks better than it did at the beginning of the two-week period”

• 62% of participants agreed that “the product is better than anything they have used before for dry skin”

Trial centre
proDERM Institute for Applied Dermatological Research, Hamburg, Germany.

Objective
To assess the potential of Bio-Oil Dry Skin Gel to cause skin irritation.

Sample
Subjects: 31 participants (26 female and 5 male), thereof 52% with sensitive skin according to self-estimation, 26% with type IV allergy (excepting cosmetic ingredients) and 48% with atopy. Age of participants: 20 to 70.

Methodology
Randomised and controlled. Three areas were evaluated: area to which demineralised water was applied (negative control), area to which Bio-Oil Dry Skin Gel was applied, and area to which Sodium Dodecyl Sulfate (SDS) 1% solution was applied (positive control – a known skin irritant). Test products were applied once on the back for a period of 24 hours using an epicutaneous patch test system. Visual evaluation to assess primary skin irritation was performed by a trained grader 15 minutes after removal of the patches, and then 24 hours and 48 hours after patch removal. Skin reactions were rated on a scale from 0 – 4 (with 0 being no response and 4 being a very red and inflamed response).

Result
No subjects experienced any adverse reactions to the test product and scores were the same as for the negative control, with a visual score of 0 (zero) recorded for all subjects at all time points. The skin tolerability of Bio-Oil Dry Skin Gel with respect to irritancy was therefore deemed to be “very good”.

Trial centre
proDERM Institute for Applied Dermatological Research, Hamburg, Germany.

Objective
To assess the potential of Bio-Oil Dry Skin Gel to form comedones (pimples).

Sample
Subjects: 24 participants with acne prone skin (17 female and 7 male). Age of participants: 24 to 56.

Methodology
Randomised and controlled. The test product (under occlusion) and two negative controls (untreated area (A) and untreated but occluded area (B)) were randomly allocated to three test areas on the acne prone region of the upper back. Test product was applied to the same test area three times per week over four weeks (12 applications in total). At the end of the study, one Skin Surface Biopsy (SSB) was taken from each of the test areas, using the method of Marks and Dawber. The presence of enlarged microcomedones was evaluated in an evaluator-blinded manner using the ranking scales of Mills and Kligman.

Result
Bio-Oil Dry Skin Gel was found to be non-comedogenic, performing significantly better than both negative controls.

Trial centre
Rigano Laboratories, Milan, Italy.

Objective
To experimentally determine the occlusivity of Bio-Oil Dry Skin Gel and thereby its ability to help the skin to retain moisture by reducing transepidermal water loss (TEWL).

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. Product was applied to the membrane and the rate of water loss from the beakers was measured over time. This was compared with the rate of water loss from control beakers, without any product on the membrane.

Result
The water vapour transmission rate (WVTR) test methodology is a standard test for measuring the occlusivity of products. A reduction in the WVTR value indicates that a particular formulation is occlusive. Bio-Oil Dry Skin Gel was shown to reduce the WVTR values statistically compared to the untreated control when applied to the Vitro-Skin™ membrane, suggesting that Bio-Oil Dry Skin Gel will help the skin to retain moisture.

Trial centre
proDERM Institute for Applied Dermatological Research, Hamburg, Germany.

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

Sample
Subjects: 36 female participants of varying ethnicities. Age of participants: 18 to 65. Scar ages: newly formed to 3 years old. Scar locations: abdomen, leg, arm, neck, knee, trunk, upper body.

Methodology
Double-blind, randomised and placebo controlled. 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 8 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 after only 2 weeks (day 15), evident in 66% of the subjects. 92% of subjects showed an improvement after 8 weeks (day 57), with the extent of the improvement almost triple that at 2 weeks. A continuous improvement of POSAS over the duration of the study.

Trial centre
Photobiology Laboratory of the Medical University of South Africa.

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

Sample
Subjects: 24 participants, 22 female and 2 male. Age of participants: 18 to 60. Scar ages: newly formed to 3 years old. Scar types: range from minor burns to surgical scars (12 major scars, 14 minor scars - 1 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 4 weeks.

Trial centre
Ayton-Moon, Somerset, United Kingdom.

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

Sample
Subjects: 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. Scar locations: various.

Methodology
Product applied 3 times daily for 4 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 4 weeks.

Trial centre
proDERM Institute for Applied Dermatological Research, Hamburg, Germany.

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

Sample
Subjects: 38 female participants of varying ethnicities. Age of participants: 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 placebo controlled. 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 8 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 after only 2 weeks (day 15), evident in 95% of the subjects. 100% of subjects showed an improvement after 8 weeks (day 57), with the extent of the improvement more than double that at 2 weeks. A continuous improvement of POSAS over the duration of the study.

Trial centre
Photobiology Laboratory of the Medical University of South Africa.

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

Sample
Subjects: 20 female participants. Age of participants: 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 8 weeks.

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

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 (ageing) skin on the face and neck.

Sample
Subjects: 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 1-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 (ageing) skin. After 4 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 and 60% in mottled pigmentation on the neck.

Trial centre
Photobiology Laboratory of the Medical University of South Africa.

Objective
To assess the efficacy of Bio-Oil in improving the appearance of uneven skin tone.

Sample
Subjects: 30 female participants of varying ethnicities. Age of participants: 18 to 55. Pigmentation type: facial melasma.

Methodology
Single-blind (assessor), randomised and controlled. Paired study design allowing for intra-subject comparison. Subjects had bilateral pigmentation, enabling half-face/neck 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 uneven skin tone in both light and dark skin types. 93% of subjects recorded an improvement in appearance at 6 weeks. Clinician noted an equal improvement in both light and dark skin types from week 0 to 8. Clinician noted more improvement in dark skin types from week 8 to 12.

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

Study 1: face & neck

Objective
To evaluate the efficacy of Bio-Oil when used by women with mild to moderate photodamaged (ageing) skin on the face and neck.

Sample
Subjects: 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 1-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 the following efficacy parameters: overall appearance, fine lines, coarse wrinkles, mottled pigmentation, uneven skin tone, visual roughness/smoothness, tactile roughness/smoothness, firm appearance, and clarity (dullness).

Result
Bio-Oil is efficacious in improving the overall appearance of photodamaged (ageing) skin on the face and neck. After 8 weeks a statistically significant result was achieved for all clinically graded efficacy parameters. After 12 weeks 94% of subjects in the Bio-Oil treatment cell showed a statistically significant improvement in overall appearance on the face and 80% of subjects showed a statistically significant improvement in overall appearance on the neck.

Study 2: body

Objective
To evaluate the efficacy of Bio-Oil when used on the décolletage, lower leg and arm skin by women with mild to moderate photodamaged (ageing) skin.

Sample
Subjects: 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 1-week washout period. Product applied to the décolletage, lower legs and arms 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 décolletage, lower legs and arms for the following efficacy parameters: overall appearance, crêpey texture, dryness/scaling, visual roughness/smoothness, and tactile roughness/smoothness.

Result
Bio-Oil is efficacious in improving the overall appearance of photodamaged (ageing) skin on the body. After 4 weeks a statistically significant result was achieved for all clinically graded efficacy parameters. After 12 weeks 89% of subjects in the Bio-Oil treatment cell showed a statistically significant improvement in overall appearance of the décolletage, lower legs and arms.

Trial centre
Photobiology Laboratory of the Medical University of South Africa.

Study 1

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

Sample
Subjects: 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. Panellists 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
Subjects: 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 7 day period. Bio-Oil and a reference oil were applied twice daily. Skin assessments were made on days 1 and 3. 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 3. Significant improvements in visual appearance of skin sites treated with Bio-Oil confirmed its effectiveness in relieving dry skin.

Trial centre
Dept. of Dermatology, Peking University First Hospital, Beijing, China.

Objective
An exploratory study to assess the efficacy of Bio-Oil in improving the appearance of facial acne scars on Chinese subjects.

Sample
Subjects: 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.

Trial centre
Future Cosmetics, Pretoria, South Africa.

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

Sample
Subjects: 21 participants, 17 female and 4 male of varying ethnicities, 50% prone to acne.

Methodology
Randomised and controlled. Product applied twice daily for 28 days. 3 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.

Trial centre
Future Cosmetics, Pretoria, South Africa.

Objective
To test whether Bio-Oil causes skin irritancy on subjects with sensitive skin.

Sample
Subjects: 21 participants. Age of participants: 18 to 65. Selection criteria: Subjects with known sensitive skin were selected and exposed to a positive control (lactic acid) to verify their sensitive skin status.

Methodology
Randomised and controlled. 3 areas were evaluated: area to which deionised water was applied (negative control), area to which Bio-Oil was applied, and area to which Sodium Lauryl Sulfate 1% solution was applied (positive control - a known skin irritant). Test products applied via a patch to the volar forearm and removed after 24 hours. Skin evaluated and reactions noted at 24, 48, 72 and 96 hours after application. Dermatologist present during the evaluations. Skin reactions rated on a scale from 0 – 4 (with 0 being no response and 4 being fiery redness).

Result
Bio-Oil was found to be a non-irritant product for subjects with sensitive skin. No subjects experienced any adverse reactions to Bio-Oil. Bio-Oil had an average reaction value of 0.03 over the period of 96 hours. Bio-Oil performed better than deionised water (negative control).

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