Clinical Trials Skincare Oil Natural2022-03-22T15:49:47+02:00

Clinical Trials – Skincare Oil Natural

Claims2022-03-22T16:19:19+02:00

A number of clinical trials, derma tests, consumer tests and lab tests have been
conducted in order to substantiate Bio‑Oil Skincare Oil (Natural)’s various claims.10
These claims are listed below and the studies themselves are described in detail
in the following sections.


– Helps improve the appearance of both new and old scars (proDERM 2020).

– Helps reduce the possibility of stretch marks forming and helps improve the
appearance of stretch marks (proDERM 2020).

– Helps improve the appearance of uneven skin tone in both light and dark skin
types (Stephens & Associates 2020).

– Helps smooth and tone ageing and wrinkled skin on the face and body and
helps retain moisture (Stephens & Associates 2020).

– Helps improve skin hydration and barrier function (Complife 2020).

– Helps improve the appearance of dry skin (Complife 2020).

– Non-comedogenic (Complife 2020).

– Suitable for sensitive skin (Complife 2020).

– Rapidly and easily absorbed (proDERM 2020).

– Occlusivity (Rigano 2020).

Scar study, 20202022-03-22T16:22:54+02:00

Trial centre

proDERM Institute for Applied Dermatological Research, Hamburg, Germany.

Objective

To assess the efficacy of Bio‑Oil Skincare Oil (Natural) in improving the
appearance of scars.

Sample

Subjects: 40 female participants of varying ethnicities. Scar ages: newly formed
to 3 years old. Scar locations: face or body due to major grazes, cuts or surgical
scars. Age of participants: 18—65.

Methodology

Evaluator blinded, randomised image assessment, open-label study. Subject
inclusion was performed by a dermatologist using the Patient and Observer Scar
Assessment Scale (POSAS). Bio‑Oil Skincare Oil (Natural) was applied twice
daily for 8 weeks by gently massaging in a circular motion on the assigned scar
and surrounding skin. Application was performed under supervision at regular
intervals. The main objective was to assess the effect of the product on the skin
investigated by means of POSAS at baseline, and at 2, 4 and 8 weeks. Further
parameters investigated at the end of the study included image assessment
of the aesthetic outcome by 6 trained assessors and subjects themselves,
and skin colour deviation of the scars to their surrounding as measured by a
Chromameter.

Result

Bio‑Oil Skincare Oil (Natural) is efficacious in improving the appearance of scars.
A statistically significant improvement in POSAS (considering both the objective
and subjective assessments of OSAS and PSAS) after only 2 weeks was evident
in 94% of the subjects. After 8 weeks 100% of subjects showed a noticeable
improvement, with the extent of the improvement more than double that at 2
weeks. A continuous and significant improvement of POSAS over the duration of
the study was noted.

Striae study, 20202022-03-22T16:24:25+02:00

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

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

Sample
Subjects: 36 female participants of varying ethnicities. Striae causes: various
(post pregnancy, weight gain, weight training or adolescent growth spurt). Striae
locations: abdomen, arms, thigh and hips. Age of participants: 18—65.

Methodology
Evaluator blinded, randomised image assessment, open-labelled study. Subject
inclusion was performed by a physician according to the Mallol Score. Bio‑Oil
Skincare Oil (Natural) was applied twice daily for 8 weeks by gently massaging
in a circular motion on the assigned striae and surrounding skin. Application 22
was performed under supervision at regular intervals. The main objective was to
assess the effect of the product on the skin investigated by means of POSAS at
baseline, and at 2, 4 and 8 weeks. A further parameter investigated at the end
of the study included image assessment of the aesthetic outcome by 6 trained
assessors and subjects themselves.

Result
Bio‑Oil Skincare Oil (Natural) is efficacious in improving the appearance of striae.
A statistically significant improvement in POSAS (considering both the objective
and subjective assessments of OSAS and PSAS) after only 2 weeks was evident
in 71% of the subjects. After 8 weeks 97% of subjects showed a noticeable
improvement, with the extent of the improvement 5 times greater than at 2
weeks. A continuous and significant improvement of POSAS over the duration of
the study was noted.

Uneven skin tone study, 20202022-03-22T16:28:47+02:00

Trial centre

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

Objective

To evaluate the efficacy of Bio‑Oil Skincare Oil (Natural) 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: 64 female participants of varying ethnicities with clinically determined
with mild to moderate photodamage on the face and neck. Bio‑Oil Skincare Oil
(Natural) treatment cell included 32 subjects and the untreated cell included 32
subjects. Age of participants: 30—70.

Methodology

Full-faced, randomised, controlled, efficacy grader-blinded study. Subjects
participated in an initial screening evaluation followed by a 1-week washout
period. For the treatment group, Bio‑Oil Skincare Oil (Natural) was applied to
the face and neck twice daily for 16 weeks, the initial application was performed
under supervision at the baseline visit. Clinical evaluations were conducted at
0, 2, 4 and 16 weeks. Subjects were clinically graded on the global face and
neck for uneven skin tone and mottled pigmentation. Digital images were also
taken of each subject’s face and neck, photo grading was performed after study
completion.

Result

Bio‑Oil Skincare Oil (Natural) is efficacious in improving the appearance of
uneven skin tone and mottled pigmentation on photodamaged (ageing) skin.
After 16 weeks a statistically significant result was achieved for both parameters 23
on the face and neck, according to clinical and photo grading. After 16 weeks,
61% and 57% of subjects in the Bio-Oil Skincare Oil (Natural) treatment cell
showed a statistically significant improvement in uneven skin tone and mottled
pigmentation respectively.

Ageing skin study, 20202022-03-22T16:31:24+02:00

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 (Natural) when used by women
with mild to moderate photodamaged (ageing) skin on the face and neck.

Sample

Subjects: 64 female participants of varying ethnicities with clinically determined
with mild to moderate photodamage on the face and neck. Bio‑Oil Skincare Oil
(Natural) treatment cell included 32 subjects and the untreated cell included 32
subjects. Age of participants: 30—70.



Methodology

Full-faced, randomised, controlled, efficacy grader-blinded study. Subjects
participated in an initial screening evaluation followed by a 1-week washout
period. For the treatment group, Bio‑Oil Skincare Oil (Natural) was applied to
the face and neck twice daily for 16 weeks, the initial application was performed
under supervision at the baseline visit. Clinical evaluations were conducted at
0, 2, 4 and 16 weeks. Subjects were clinically graded on the global face and
neck for the following efficacy parameters: fine lines, coarse wrinkles, visual
roughness/smoothness, tactile roughness/smoothness, mottled pigmentation,
uneven skin tone, clarity (dullness), visual firmness and global assessment of
appearance. Digital images were also taken of each subject’s face and neck,
photo grading was performed after study completion. The images taken at
each time point were graded globally for fine lines, coarse wrinkles, mottled
pigmentation, uneven skin tone, clarity (dullness) and global assessment of
appearance.



Result

Bio‑Oil Skincare Oil (Natural) is efficacious in improving the overall appearance
of photodamaged (ageing) skin on the face and neck. After 16 weeks the Bio‑Oil
Skincare Oil (Natural) treatment group significantly outperformed the untreated
control group for all clinically and photo graded efficacy parameters. This was
clinically observed from 4 weeks, except for mottled pigmentation. After 16
weeks, 54% of subjects in the Bio-Oil Skincare Oil (Natural) treatment cell
showed a statistically significant improvement in overall appearance of the face
and neck.

Study 2: Body

Objective

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

Sample

Subjects: 64 female participants of varying ethnicities with clinically determined
mild to moderate photodamage on the face and neck. Bio‑Oil Skincare Oil
(Natural) treatment cell included 32 subjects and the untreated cell included 32
subjects. Age of participants: 30—70.

Methodology

Randomised, controlled, efficacy grader-blinded study. Subjects participated
in an initial screening evaluation followed by a 1-week washout period. For the
treatment group, Bio‑Oil Skincare Oil (Natural) was applied to the décolletage,
lower legs and arms twice daily for 16 weeks, the initial application was
performed under supervision at the baseline visit. Clinical evaluations were
conducted at 0, 2, 4 and 16 weeks. Subjects were clinically graded separately
on the décolletage, lower legs and arms for the following efficacy parameters:
visual roughness/smoothness, tactile roughness/smoothness, dryness/scaling,
visual crêpey texture and global assessment of appearance.

Result

Bio‑Oil Skincare Oil (Natural) is efficacious in improving the overall appearance
of photodamaged (ageing) skin on the body. After 2 weeks the Bio‑Oil Skincare
Oil (Natural) treatment group significantly outperformed the untreated control
group for all clinically graded efficacy parameters. After 16 weeks, 82%, 93%
and 71% of subjects in the Bio-Oil Skincare Oil (Natural) treatment cell showed
a statistically significant improvement in overall appearance of the décolletage,
lower legs and arms respectively.

Dehydrated skin study, 20202022-03-22T16:35:02+02:00

Trial centre

Complife Italia S.r.l, Italy.

Study 1: Stratum corneum hydration and barrier function

Objective

To assess the efficacy of a single application of Bio‑Oil Skincare Oil (Natural) to
improve stratum corneum hydration and barrier function.

Sample
Subjects: 40 female participants of varying ethnicities. Test site: test product
applied to the inner volar forearm of all subjects. Age of participants: over 18
years old.

Methodology

A randomised, blinded and controlled study. Assessment of skin hydration with
a Corneometer, assessment of barrier function with a Tewameter. Participants
washed their forearms with soap 2 hours before measurements were taken in
order to induce skin dryness. Baseline instrumental measurements were taken.
Bio‑Oil Skincare Oil (Natural) was then applied to a site on the inner volar forearm
of all subjects. Measurements were taken again immediately after product
application as well as 1 and 2 hours later, before and after wiping the product off.
A control untreated site was also measured at all time points.

Result

Bio‑Oil Skincare Oil (Natural) treatment resulted in a significant improvement of
skin moisturisation and a significant decrease of transepidermal water loss (an
index of improvement in skin barrier condition) at each experimental monitored
check, compared to dehydrated skin.


Study 2: Appearance of dry skin

Objective

To assess the efficacy of Bio‑Oil Skincare Oil (Natural) in improving the
appearance of dry skin.

Sample

Subjects: 25 female Caucasian participants clinically showing dry/very dry
desquamated skin at the level of the outer lower legs. Test site: test product
applied to the outer, lower leg of all subjects. Age of participants: 25—65 years
old.



Methodology

A randomised, double blinded and controlled clinical-instrumental study. Clinical
evaluations of dry skin were performed by a trained visual evaluator, assessment
of skin hydration with a Corneometer and assessment of barrier function with a
Tewameter. Participants washed their legs with soap to induce dry skin over a
7-day period. Baseline instrumental measurements were taken. Bio‑Oil Skincare
Oil (Natural) was applied twice daily. Clinical assessments and instrumental
evaluations were made on days 1 and 3. A control untreated site was also
evaluated at all time points.

Result

Bio‑Oil Skincare Oil (Natural) treatment resulted in a significant improvement of
skin moisturisation and a significant decrease of transepidermal water loss (an
index of improvement in skin barrier condition) at each experimental monitored
check, compared to dehydrated skin. Instrumental results are confirmed by the
clinical analysis of skin dryness, carried out by the dermatologist.

Combined Study Result

The significant improvement in the visual appearance of dry skin treated with
Bio‑Oil Skincare Oil (Natural) in study two confirms its effectiveness in relieving
dry and dehydrated skin. This is further supported with the improvements in
stratum corneum barrier function and transepidermal water loss in both studies.

Sensitive skin test, 20202022-03-22T16:36:32+02:00

Trial centre

Complife Italia S.r.l, Italy.

ObjectiveTo assess the potential of Bio‑Oil Skincare Oil (Natural) to cause skin irritation.

Sample

25 participants, 3 male and 22 female, all with sensitive skin according to lactic
acid stinging test. Age of participants: 18—70.

Methodology

Controlled study. Two areas were evaluated: area to which a negative control
was applied (demineralised water) and an area to which Bio‑Oil Skincare Oil
(Natural) was applied. Test products were applied to the backs of participants, in
contact with the skin surface, 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 erythema and
oedema, indicating dark red appearance and extended swelling and beyond the
application area).

Result

The skin tolerability of Bio‑Oil Skincare Oil (Natural) was deemed ‘non-irritating’.

Non-comedogenic study, 20202022-03-22T16:38:09+02:00

Trial centre

Complife Italia S.r.l, Italy.



Objective

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



Sample

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

Methodology

Controlled study. 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 (Natural)) and a positive control
(lanolin alcohol, a known comedogenic product).
Skin reactions were clinically evaluated under the supervision of a dermatologist
15 minutes after the removal of each patch to compare the presence of
comedones before and after each product application.



Result

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

Absorption study, 20202022-03-22T16:39:30+02:00

Trial centre

proDERM Institute for Applied Dermatological Research, Hamburg, Germany.

Objective

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

Sample

Subjects: 100 participants (74 female and 26 male). Test site: test products
applied to the inner volar forearm of all participants.

Methodology

Double-blind, randomised and controlled study. Bio‑Oil Skincare Oil (Natural) and
a reference oil were applied to assigned test areas on the inner 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 (Natural) into the skin was assessed as
‘very fast’ or ‘fast’ by the majority (64%) of participants.

Occlusivity study, 20202022-03-22T16:41:01+02:00

Trial centre

Rigano Laboratories, Milan, Italy.

Objective

To evaluate whether Bio‑Oil Skincare Oil (Natural) demonstrates a similar
occlusivity level to vernix caseosa.

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. Equal quantities of vernix caseosa and Bio‑Oil Skincare Oil (Natural)
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 (Natural) demonstrated a very similar occlusivity level to
vernix caseosa, registering 24.9 compared to vernix caseosa’s 27.1.

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