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.
