Trial centre
Complife, Italy.

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

Sample
Subjects: 20 participants, 14 female and 6 male of varying ethnicities with acne prone skin. Age of participants: 18 to 65.

Methodology
Randomised and controlled. The product was applied on a disk of filter paper to the upper back region of participants. Patches were left in place for 48 to 72 hours, removed and applied again. A total of 12 patches were applied for 4 consecutive weeks. Three areas were evaluated by comparing a negative control (demineralised water), the test product (Bio‑Oil Skincare Oil) and a positive control (lanolin alcohol, a known comedogenic product). Skin reactions were clinically evaluated under the supervision of a dermatologist 15 minutes of the removal of each
patch and the presence of comedones was compared to before and after product exposure.

Result
Bio‑Oil Skincare Oil was found to be non-comedogenic. The area to which Bio‑Oil Skincare Oil was applied showed no significant difference to the negative control area. The positive control induced acne.

Trial centre
Complife, Italy.

Objective
To assess the potential of Bio‑Oil Skincare Oil to cause skin irritation.

Sample
25 participants, 19 male and 6 female, all with sensitive skin according to lactic acid stinging test. Age of participants: 18 to 65.

Methodology
Randomised and controlled. Two areas were evaluated: area to which a negative control was applied (demineralised water) and an area to which Bio‑Oil Skincare Oil was applied. Tests were applied to the back of the hands of participants for a period of 48 hours using a Fin chamber. Skin reactions were evaluated under the supervision of a dermatologist, to assess primary skin irritation at 15 minutes, 1 hour and 24 hours after patch removal. Skin reactions were rated on a scale from 0 – 4 (with 0 being no erythema, oedema, or other types of skin irritation, and 4 being serious cause of erythema and oedema, indicating swelling and dark red appearance beyond the application area.

Result
No subjects experienced any adverse reactions to the test product, with a visual score of 0 (zero) recorded for all subjects at all timepoints. The skin tolerability of Bio‑Oil Skincare Oil was deemed ‘non-irritating’.

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

Study 1: Trained raters

Objective
To assess the rate of absorption of Bio‑Oil Skincare Oil after standardised application and rubbing in.

Sample
Subjects: 22 trained raters (21 female and 1 male). Test site: test products applied to the volar forearm of all raters.

Methodology
Double-blind, randomised and controlled. Bio‑Oil Skincare Oil and a reference oil were applied to assigned test areas on the volar forearms of raters. Raters performed 100 cyclic movements at a defined speed. Raters then rated the absorption of the products on a 5-point scale from ‘very slow absorbing’ to ‘very fast absorbing’. Sebumeter measurements, to assess the amount of oil on the skin, were taken at 2 time points; before application and 2 minutes after product application.

Result
The absorbency of Bio‑Oil Skincare Oil into the skin was assessed as ‘very fast’ or ‘fast’ by the majority (77.3%) of trained raters. This was verified through instrumental measurement with sebumeter readings at the second time point showing that the amount of Bio‑Oil Skincare Oil left on the skin was significantly lower than compared with the reference oil.

Study 2: Random participants

Objective
To assess the rate of absorption of Bio‑Oil Skincare Oil after standardised application and rubbing in.

Sample
Subjects: 100 participants (97 female and 3 male). Test site: test products applied to the volar forearm of all participants.

Methodology
Double-blind, randomised and controlled. Bio‑Oil Skincare Oil and a reference oil were applied to assigned test areas on the volar forearms of participants. Participants rubbed in the test product for 1 minute each. Participants then rated the absorption of the products on a 5-point scale from ‘very slow absorbing’ to ‘very fast absorbing’.

Result
The absorbency of Bio‑Oil Skincare Oil into the skin was assessed as ‘very fast’ or ‘fast’ by the majority (72%) of participants.

Trial centre
Photobiology Laboratory of the Medical University of South Africa. Study 1: Stratum corneum hydration and barrier function

Objective
To assess the effect of a single application of Bio‑Oil Skincare 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 Skincare 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 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 Skincare Oil showed further increased TEWL values compared to the reference oil, indicating increased moisture release and therefore increased skin hydration.

Study 2: Appearance of dry skin

Objective
To assess the effect of twice daily application of Bio‑Oil Skincare 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 Skincare 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. An untreated control site was also evaluated at all time points.

Result
Both Bio‑Oil Skincare Oil and the reference oil improved skin dryness compared with the no treatment control. Bio‑Oil Skincare Oil was statistically superior on day 3. Significant improvements in visual appearance of skin sites treated with Bio‑Oil Skincare Oil confirmed its effectiveness in relieving dry skin.

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

Study 1: Face and neck

Objective
To evaluate the efficacy of Bio‑Oil Skincare 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 Skincare 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 the baseline visit. Clinical evaluations were 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 Skincare 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 Skincare 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

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

Objective
To evaluate the efficacy of Bio‑Oil Skincare 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 Skincare 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 was performed under supervision at the baseline visit. Clinical evaluations were 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 Skincare 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 Skincare Oil treatment cell showed a statistically significant improvement in overall appearance of the décolletage, lower legs and arms.

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

Objective
To evaluate the efficacy of Bio‑Oil Skincare 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 Skincare 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 Skincare 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 Skincare 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
proDERM Institute for Applied Dermatological Research, Hamburg, Germany.

Objective
To assess the efficacy of Bio‑Oil Skincare Oil in improving the appearance of striae.

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

Methodology
Double-blind, randomised and placebo controlled. Subjects had matching striae or striae large enough to allow a half-half striae application and intrasubject 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 Skincare Oil is efficacious in improving the appearance of striae. A statistically significant result after only 2 weeks (day 15), evident in 95% of the subjects. After 8 weeks (day 57) 100% of subjects showed an improvement, 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
proDERM Institute for Applied Dermatological Research, Hamburg, Germany.

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

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

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 Skincare 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. After 8 weeks (day 57) 92% of subjects showed an improvement, 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
Trial conducted by Prof. Dr. J Wiechers at Rigano Laboratories, Milan, Italy.

Objective
To evaluate whether Bio‑Oil Skincare Oil demonstrates a similar occlusivity level to vernix caseosa. Vernix caseosa 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 semipermeable membrane called Vitro-Skin™, which mimics the surface properties of human skin. Vernix caseosa and Bio-Oil Skincare 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 Skincare Oil demonstrated a very similar occlusivity level to vernix
caseosa, registering 23.5 compared to vernix caseosa’s 27.2.

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

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

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

Methodology
Single-blind (assessor), randomised and controlled. Paired study design allowing for intra-subject comparison. Subjects had bilateral pigmentation, enabling halfface/ 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 Skincare 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
Photobiology Laboratory of the Medical University of South Africa.

Objective
To assess the efficacy of Bio‑Oil Skincare Oil in improving the appearance of striae.

Sample
Subjects: 20 female participants. Striae location: abdomen. Age of participants: 18 to 55.

Methodology
Single-blind (assessor), randomised and controlled. Paired study design allowing for intra-subject comparison. Subjects had bilateral abdominal striae, 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 Skincare Oil improved the appearance of striae in both objective and subjective assessments. 50% of subjects recorded an improvement in appearance at 8 weeks.

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

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

Sample
Subjects: 24 participants, 22 female and 2 male. 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 3 scar sites). Age of participants: 18 to 60.

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 Skincare 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 Skincare 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 to 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.