| Primary | Change From Baseline in Overall Photodamage Score | The investigator assessed the participant's overall photodamage using a 10-point scale where None (0)= Facial skin is smooth to the touch, without significant fine/coarse line or skin tone unevenness in any areas (periocular, cheeks, forehead and perioral areas) to Severe (7 to 9)= Facial skin shows 3 or more areas (periocular, cheeks, forehead and perioral areas) of significant roughness, skin tone unevenness (red/brown), or fine/coarse lines at Baseline and Week 12. A decrease in score indicates improvement. A negative change from Baseline indicates improvement. | ITT Population included all enrolled participants who applied the test product and completed one follow-up visit after test product was initiated. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (Day 1) to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Retinol Complex 0.5 | During a 2-week washout period the participant used a basic skin care regimen (SkinMedica facial cleanser in the morning and in the evening, Cetaphil Fragrance Free Moisturizing Lotion in the morning and in the evening and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen in the morning and as needed), followed by the same basic skin care regimen plus SkinMedica Retinol Complex 0.5 applied topically to the face in the evening for 12 Weeks. Assessments of the participant's facial skin were made utilizing investigator clinical grading, digital photography, a spectrophotometer and in vivo skin imaging. |
| | | Title | Denominators | Categories |
|---|
| Baseline (BL) | | | | Change from BL at Week 12 | | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| Change from Baseline at Week 12 | Paired t-test | | <0.001 | Statistical significance is defined as a p-value ≤0.05. | | | | | | | | | | | | | Other | Testing hypothesis is that the mean change from baseline is zero. | |
|
| Primary | Change From Baseline in Appearance of Fine Lines/Wrinkles Score (Forehead, Periocular, Cheeks and Perioral Areas Individually Assessed) | The investigator assessed the participant's appearance of fine lines/wrinkles using a 10-point scale where None (0)= No fine lines/wrinkles present; skin looks completely smooth and wrinkle-free to Severe (7 to 9)= Many coarse lines/wrinkles densely packed together in the treatment area (forehead, periocular, cheeks and perioral areas) at Baseline and Week 12. A decrease in score indicates improvement. A negative change from Baseline indicates improvement. | ITT Population included all enrolled participants who applied the test product and completed one follow-up visit after test product was initiated. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (Day 1) to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Retinol Complex 0.5 | During a 2-week washout period the participant used a basic skin care regimen (SkinMedica facial cleanser in the morning and in the evening, Cetaphil Fragrance Free Moisturizing Lotion in the morning and in the evening and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen in the morning and as needed), followed by the same basic skin care regimen plus SkinMedica Retinol Complex 0.5 applied topically to the face in the evening for 12 Weeks. Assessments of the participant's facial skin were made utilizing investigator clinical grading, digital photography, a spectrophotometer and in vivo skin imaging. |
| |
| Primary | Change From Baseline in Appearance of Coarse Lines/Wrinkles Score (Forehead, Periocular, Cheeks and Perioral Areas Individually Assessed) | The investigator assessed the participant's appearance of coarse lines/wrinkles using a 10-point scale where None (0)= No coarse lines/wrinkles present; skin looks completely smooth and wrinkle-free to Severe (7 to 9)= Many coarse lines/wrinkles densely packed together in the treatment area (forehead, periocular, cheeks and perioral areas) at Baseline and Week 12. A decrease in score indicates improvement. A negative change from Baseline indicates improvement. | ITT Population included all enrolled participants who applied study treatment and completed one follow-up visit after test product was initiated. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (Day 1) to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Retinol Complex 0.5 | During a 2-week washout period the participant used a basic skin care regimen (SkinMedica facial cleanser in the morning and in the evening, Cetaphil Fragrance Free Moisturizing Lotion in the morning and in the evening and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen in the morning and as needed), followed by the same basic skin care regimen plus SkinMedica Retinol Complex 0.5 applied topically to the face in the evening for 12 Weeks. Assessments of the participant's facial skin were made utilizing investigator clinical grading, digital photography, a spectrophotometer and in vivo skin imaging. |
| |
| Primary | Change From Baseline in Tactile Roughness Score | The investigator assessed the participant's tactile roughness in the entire face using a 10-point scale where None (0)= No roughness of the treatment area; skin is completely smooth and pliable to Severe (7 to 9)= Marked roughness of the treatment area associated with stiff feeling at Baseline and Week 12. A decrease in score indicates improvement. A negative change from Baseline indicates improvement. | ITT Population included all enrolled participants who applied study treatment and completed one follow-up visit after test product was initiated. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (Day 1) to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Retinol Complex 0.5 | During a 2-week washout period the participant used a basic skin care regimen (SkinMedica facial cleanser in the morning and in the evening, Cetaphil Fragrance Free Moisturizing Lotion in the morning and in the evening and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen in the morning and as needed), followed by the same basic skin care regimen plus SkinMedica Retinol Complex 0.5 applied topically to the face in the evening for 12 Weeks. Assessments of the participant's facial skin were made utilizing investigator clinical grading, digital photography, a spectrophotometer and in vivo skin imaging. |
| |
| Secondary | Change From Baseline in Skin Roughness Score Using the Allergan Skin Roughness Visual Scale | The investigator assessed the participant's skin roughness using the Allergan Skin Roughness Visual 5-Point Scale where None (0)= Smooth visual skin texture to Extreme (4)= Extremely coarse visual skin texture, crosshatched deep creases; extreme elastosis at Baseline and Week 12. A decrease in score indicates improvement. A negative change from Baseline indicates improvement. | ITT Population included all enrolled participant who applied study treatment and completed one follow-up visit after test product was initiated. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (Day 1) to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Retinol Complex 0.5 | During a 2-week washout period the participant used a basic skin care regimen (SkinMedica facial cleanser in the morning and in the evening, Cetaphil Fragrance Free Moisturizing Lotion in the morning and in the evening and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen in the morning and as needed), followed by the same basic skin care regimen plus SkinMedica Retinol Complex 0.5 applied topically to the face in the evening for 12 Weeks. Assessments of the participant's facial skin were made utilizing investigator clinical grading, digital photography, a spectrophotometer and in vivo skin imaging. |
| |
| Secondary | Change From Baseline in Appearance of Fine Lines Score Using the Allergan Fine Lines Visual Scale | The investigator assessed the participant's fine lines using the Allergan Fine Lines Visual 5-Point Scale where None (0)= No fine lines to Diffuse (4)= Diffuse superficial lines; crosshatching at Baseline and Week 12. A decrease in score indicates improvement. A negative change from Baseline indicates improvement. | ITT Population included all enrolled participants who applied study treatment and completed one follow-up visit after test product was initiated. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (Day 1) to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Retinol Complex 0.5 | During a 2-week washout period the participant used a basic skin care regimen (SkinMedica facial cleanser in the morning and in the evening, Cetaphil Fragrance Free Moisturizing Lotion in the morning and in the evening and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen in the morning and as needed), followed by the same basic skin care regimen plus SkinMedica Retinol Complex 0.5 applied topically to the face in the evening for 12 Weeks. Assessments of the participant's facial skin were made utilizing investigator clinical grading, digital photography, a spectrophotometer and in vivo skin imaging. |
| |
| Secondary | Investigator's Global Improvement Assessment for Overall Photodamage | The investigator assessed the global improvement in the participant's overall photodamage compared to Baseline using a 5-point scale where None (0)= No change or worsening to Complete (4)= Almost complete improvement of the condition with a trace of signs/symptoms remaining (approximately 95% or better overall improvement). | ITT Population included all enrolled participants who applied study treatment and completed one follow-up visit after test product was initiated. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (Day 1) to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Retinol Complex 0.5 | During a 2-week washout period the participant used a basic skin care regimen (SkinMedica facial cleanser in the morning and in the evening, Cetaphil Fragrance Free Moisturizing Lotion in the morning and in the evening and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen in the morning and as needed), followed by the same basic skin care regimen plus SkinMedica Retinol Complex 0.5 applied topically to the face in the evening for 12 Weeks. Assessments of the participant's facial skin were made utilizing investigator clinical grading, digital photography, a spectrophotometer and in vivo skin imaging. |
| |
| Secondary | Investigator's Global Improvement Assessment for the Appearance of Fine Lines/Wrinkles (Forehead, Periocular, Cheeks, Perioral Areas Individually Assessed) | The investigator assessed the global improvement in the participant's overall appearance of fine lines/wrinkles compared to Baseline using a 5-point scale where None (0)= No change or worsening to Complete (4)= Complete clearing in the appearance of fine lines/wrinkles (approximately 95% or better overall improvement). | ITT Population included all enrolled participants who applied study treatment and completed one follow-up visit after test product was initiated. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (Day 1) to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Retinol Complex 0.5 | During a 2-week washout period the participant used a basic skin care regimen (SkinMedica facial cleanser in the morning and in the evening, Cetaphil Fragrance Free Moisturizing Lotion in the morning and in the evening and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen in the morning and as needed), followed by the same basic skin care regimen plus SkinMedica Retinol Complex 0.5 applied topically to the face in the evening for 12 Weeks. Assessments of the participant's facial skin were made utilizing investigator clinical grading, digital photography, a spectrophotometer and in vivo skin imaging. |
| |
| Secondary | Investigator's Global Improvement Assessment for the Appearance of Coarse Lines/Wrinkles (Forehead, Periocular, Cheeks, Perioral Areas Individually Assessed) | The investigator assessed the global improvement in the participant's overall appearance of coarse lines/wrinkles compared to Baseline using a 5-point scale where None (0)= No change or worsening to Complete (4)= Complete clearing in the appearance of coarse lines/wrinkles (approximately 95% or better overall improvement). | ITT Population included all enrolled participants who applied study treatment and completed one follow-up visit after test product was initiated. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (Day 1) to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Retinol Complex 0.5 | During a 2-week washout period the participant used a basic skin care regimen (SkinMedica facial cleanser in the morning and in the evening, Cetaphil Fragrance Free Moisturizing Lotion in the morning and in the evening and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen in the morning and as needed), followed by the same basic skin care regimen plus SkinMedica Retinol Complex 0.5 applied topically to the face in the evening for 12 Weeks. Assessments of the participant's facial skin were made utilizing investigator clinical grading, digital photography, a spectrophotometer and in vivo skin imaging. |
| |
| Secondary | Investigator's Global Improvement Assessment for Tactile Roughness | The investigator assessed the global improvement in the participant's overall tactile roughness compared to Baseline using a 5-point scale where None (0)= No change or worsening to Complete (4)= Complete clearing in the appearance of tactile roughness (approximately 95% or better overall improvement). | ITT Population included all enrolled participants who applied study treatment and completed one follow-up visit after test product was initiated. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (Day 1) to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Retinol Complex 0.5 | During a 2-week washout period the participant used a basic skin care regimen (SkinMedica facial cleanser in the morning and in the evening, Cetaphil Fragrance Free Moisturizing Lotion in the morning and in the evening and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen in the morning and as needed), followed by the same basic skin care regimen plus SkinMedica Retinol Complex 0.5 applied topically to the face in the evening for 12 Weeks. Assessments of the participant's facial skin were made utilizing investigator clinical grading, digital photography, a spectrophotometer and in vivo skin imaging. |
| |
| Secondary | Change From Baseline in Spectrophotometer L* Value (a Measurement of Skin Brightness) | Triplicate spectrophotometer readings were taken of the participant's face (Normal Skin and Target Lesions) at Baseline and Week 12. L* value scores range from 0=black to 100=white. An increase in the spectrophotometer L* values indicates improvement. A positive change from Baseline indicates improvement. | ITT Population included all enrolled participants who applied study treatment and completed one follow-up visit after test product was initiated. Number analyzed is the number of participants with data available at the given time-point for analysis. | Posted | | Mean | Standard Error | score on a scale | | Baseline (Day 1) to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Retinol Complex 0.5 | During a 2-week washout period the participant used a basic skin care regimen (SkinMedica facial cleanser in the morning and in the evening, Cetaphil Fragrance Free Moisturizing Lotion in the morning and in the evening and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen in the morning and as needed), followed by the same basic skin care regimen plus SkinMedica Retinol Complex 0.5 applied topically to the face in the evening for 12 Weeks. Assessments of the participant's facial skin were made utilizing investigator clinical grading, digital photography, a spectrophotometer and in vivo skin imaging. |
| |