Ageing skin study, 2011

Trial centre

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

Study 1: face & neck

Objective

To evaluate the efficacy of Bi-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. Bi-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

Bi-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 Bi-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 Bi-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. Bi-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

Bi-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 Bi-Oil treatment cell showed a statistically significant improvement in overall appearance of the décolletage, lower legs and arms.