Trial Outcomes & Findings for Study to Assess the Cosmetic Changes in the Facial Skin After Use of a Topical Retinoid Product in Participants With Moderate to Severe Photodamage (NCT NCT03302559)
NCT ID: NCT03302559
Last Updated: 2019-06-04
Results Overview
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.
COMPLETED
NA
29 participants
Baseline (Day 1) to Week 12
2019-06-04
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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29
|
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Overall Study
COMPLETED
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23
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Overall Study
NOT COMPLETED
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6
|
Reasons for withdrawal
| Measure |
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.
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|---|---|
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Overall Study
Adverse Event
|
2
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Overall Study
Lost to Follow-up
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1
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Overall Study
Withdrew Consent
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3
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Baseline Characteristics
Study to Assess the Cosmetic Changes in the Facial Skin After Use of a Topical Retinoid Product in Participants With Moderate to Severe Photodamage
Baseline characteristics by cohort
| Measure |
Retinol Complex 0.5
n=23 Participants
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.
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|---|---|
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Age, Continuous
|
55 years
STANDARD_DEVIATION 7.9 • n=5 Participants
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Sex: Female, Male
Female
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21 Participants
n=5 Participants
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Sex: Female, Male
Male
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2 Participants
n=5 Participants
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Race/Ethnicity, Customized
Caucasian
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11 Participants
n=5 Participants
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Race/Ethnicity, Customized
Hispanic
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3 Participants
n=5 Participants
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Race/Ethnicity, Customized
Asian
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8 Participants
n=5 Participants
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Race/Ethnicity, Customized
Other
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1 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Baseline (Day 1) to Week 12Population: ITT Population included all enrolled participants who applied the test product and completed one follow-up visit after test product was initiated.
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.
Outcome measures
| Measure |
Retinol Complex 0.5
n=23 Participants
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.
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|---|---|
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Change From Baseline in Overall Photodamage Score
Baseline (BL)
|
5.6 score on a scale
Standard Deviation 0.9
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Change From Baseline in Overall Photodamage Score
Change from BL at Week 12
|
-0.8 score on a scale
Standard Deviation 0.5
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PRIMARY outcome
Timeframe: Baseline (Day 1) to Week 12Population: ITT Population included all enrolled participants who applied the test product and completed one follow-up visit after test product was initiated.
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.
Outcome measures
| Measure |
Retinol Complex 0.5
n=23 Participants
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.
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|---|---|
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Change From Baseline in Appearance of Fine Lines/Wrinkles Score (Forehead, Periocular, Cheeks and Perioral Areas Individually Assessed)
Baseline (Forehead)
|
3.4 score on a scale
Standard Deviation 1.5
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Change From Baseline in Appearance of Fine Lines/Wrinkles Score (Forehead, Periocular, Cheeks and Perioral Areas Individually Assessed)
Change from BL at Week 12 (Forehead)
|
-0.8 score on a scale
Standard Deviation 1.2
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|
Change From Baseline in Appearance of Fine Lines/Wrinkles Score (Forehead, Periocular, Cheeks and Perioral Areas Individually Assessed)
Baseline (Periocular)
|
4.7 score on a scale
Standard Deviation 1.5
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Change From Baseline in Appearance of Fine Lines/Wrinkles Score (Forehead, Periocular, Cheeks and Perioral Areas Individually Assessed)
Change from BL at Week 12 (Periocular)
|
-1.0 score on a scale
Standard Deviation 1.8
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Change From Baseline in Appearance of Fine Lines/Wrinkles Score (Forehead, Periocular, Cheeks and Perioral Areas Individually Assessed)
Baseline (Cheeks)
|
3.6 score on a scale
Standard Deviation 1.5
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Change From Baseline in Appearance of Fine Lines/Wrinkles Score (Forehead, Periocular, Cheeks and Perioral Areas Individually Assessed)
Change from BL at Week 12 (Cheeks)
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-1.1 score on a scale
Standard Deviation 1.3
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Change From Baseline in Appearance of Fine Lines/Wrinkles Score (Forehead, Periocular, Cheeks and Perioral Areas Individually Assessed)
Baseline (Perioral)
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4.0 score on a scale
Standard Deviation 1.6
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Change From Baseline in Appearance of Fine Lines/Wrinkles Score (Forehead, Periocular, Cheeks and Perioral Areas Individually Assessed)
Change from BL at Week 12 (Perioral)
|
-0.9 score on a scale
Standard Deviation 1.2
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PRIMARY outcome
Timeframe: Baseline (Day 1) to Week 12Population: ITT Population included all enrolled participants who applied study treatment and completed one follow-up visit after test product was initiated.
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.
Outcome measures
| Measure |
Retinol Complex 0.5
n=23 Participants
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.
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|---|---|
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Change From Baseline in Appearance of Coarse Lines/Wrinkles Score (Forehead, Periocular, Cheeks and Perioral Areas Individually Assessed)
Baseline (Forehead)
|
4.9 score on a scale
Standard Deviation 1.4
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Change From Baseline in Appearance of Coarse Lines/Wrinkles Score (Forehead, Periocular, Cheeks and Perioral Areas Individually Assessed)
Change from BL at Week 12 (Forehead)
|
-0.6 score on a scale
Standard Deviation 1.1
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Change From Baseline in Appearance of Coarse Lines/Wrinkles Score (Forehead, Periocular, Cheeks and Perioral Areas Individually Assessed)
Baseline (Periocular)
|
6.0 score on a scale
Standard Deviation 1.2
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Change From Baseline in Appearance of Coarse Lines/Wrinkles Score (Forehead, Periocular, Cheeks and Perioral Areas Individually Assessed)
Change from Baseline at Week 12 (Periocular)
|
-0.7 score on a scale
Standard Deviation 1.0
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Change From Baseline in Appearance of Coarse Lines/Wrinkles Score (Forehead, Periocular, Cheeks and Perioral Areas Individually Assessed)
Baseline (Cheeks)
|
3.5 score on a scale
Standard Deviation 2.4
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Change From Baseline in Appearance of Coarse Lines/Wrinkles Score (Forehead, Periocular, Cheeks and Perioral Areas Individually Assessed)
Change from Baseline at Week 12 (Cheeks)
|
-1.1 score on a scale
Standard Deviation 1.1
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Change From Baseline in Appearance of Coarse Lines/Wrinkles Score (Forehead, Periocular, Cheeks and Perioral Areas Individually Assessed)
Baseline (Perioral)
|
4.4 score on a scale
Standard Deviation 1.9
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|
Change From Baseline in Appearance of Coarse Lines/Wrinkles Score (Forehead, Periocular, Cheeks and Perioral Areas Individually Assessed)
Change from BL at Week 12 (Perioral)
|
-0.2 score on a scale
Standard Deviation 1.2
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PRIMARY outcome
Timeframe: Baseline (Day 1) to Week 12Population: ITT Population included all enrolled participants who applied study treatment and completed one follow-up visit after test product was initiated.
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.
Outcome measures
| Measure |
Retinol Complex 0.5
n=23 Participants
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.
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|---|---|
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Change From Baseline in Tactile Roughness Score
Baseline
|
4.0 score on a scale
Standard Deviation 1.7
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Change From Baseline in Tactile Roughness Score
Change from BL at Week 12
|
-1.1 score on a scale
Standard Deviation 1.6
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SECONDARY outcome
Timeframe: Baseline (Day 1) to Week 12Population: ITT Population included all enrolled participant who applied study treatment and completed one follow-up visit after test product was initiated.
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.
Outcome measures
| Measure |
Retinol Complex 0.5
n=23 Participants
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.
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|---|---|
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Change From Baseline in Skin Roughness Score Using the Allergan Skin Roughness Visual Scale
Baseline
|
1.8 score on a scale
Standard Deviation 1.1
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Change From Baseline in Skin Roughness Score Using the Allergan Skin Roughness Visual Scale
Change from BL at Week 12
|
-0.5 score on a scale
Standard Deviation 0.6
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SECONDARY outcome
Timeframe: Baseline (Day 1) to Week 12Population: ITT Population included all enrolled participants who applied study treatment and completed one follow-up visit after test product was initiated.
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.
Outcome measures
| Measure |
Retinol Complex 0.5
n=23 Participants
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.
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|---|---|
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Change From Baseline in Appearance of Fine Lines Score Using the Allergan Fine Lines Visual Scale
Baseline
|
4.0 score on a scale
Standard Deviation 1.7
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Change From Baseline in Appearance of Fine Lines Score Using the Allergan Fine Lines Visual Scale
Change from BL at Week 12
|
-0.3 score on a scale
Standard Deviation 0.6
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SECONDARY outcome
Timeframe: Baseline (Day 1) to Week 12Population: ITT Population included all enrolled participants who applied study treatment and completed one follow-up visit after test product was initiated.
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).
Outcome measures
| Measure |
Retinol Complex 0.5
n=23 Participants
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.
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|---|---|
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Investigator's Global Improvement Assessment for Overall Photodamage
|
1.5 score on a scale
Standard Deviation 0.7
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SECONDARY outcome
Timeframe: Baseline (Day 1) to Week 12Population: ITT Population included all enrolled participants who applied study treatment and completed one follow-up visit after test product was initiated.
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).
Outcome measures
| Measure |
Retinol Complex 0.5
n=23 Participants
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.
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|---|---|
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Investigator's Global Improvement Assessment for the Appearance of Fine Lines/Wrinkles (Forehead, Periocular, Cheeks, Perioral Areas Individually Assessed)
Week 12 (Forehead)
|
1.1 score on a scale
Standard Deviation 0.6
|
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Investigator's Global Improvement Assessment for the Appearance of Fine Lines/Wrinkles (Forehead, Periocular, Cheeks, Perioral Areas Individually Assessed)
Week 12 (Periocular)
|
1.6 score on a scale
Standard Deviation 0.9
|
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Investigator's Global Improvement Assessment for the Appearance of Fine Lines/Wrinkles (Forehead, Periocular, Cheeks, Perioral Areas Individually Assessed)
Week 12 (Cheeks)
|
1.3 score on a scale
Standard Deviation 0.6
|
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Investigator's Global Improvement Assessment for the Appearance of Fine Lines/Wrinkles (Forehead, Periocular, Cheeks, Perioral Areas Individually Assessed)
Week 12 (Perioral)
|
1.2 score on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Week 12Population: ITT Population included all enrolled participants who applied study treatment and completed one follow-up visit after test product was initiated.
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).
Outcome measures
| Measure |
Retinol Complex 0.5
n=23 Participants
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.
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|---|---|
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Investigator's Global Improvement Assessment for the Appearance of Coarse Lines/Wrinkles (Forehead, Periocular, Cheeks, Perioral Areas Individually Assessed)
Week 12 (Forehead)
|
0.8 score on a scale
Standard Deviation 0.8
|
|
Investigator's Global Improvement Assessment for the Appearance of Coarse Lines/Wrinkles (Forehead, Periocular, Cheeks, Perioral Areas Individually Assessed)
Week 12 (Periocular)
|
1.6 score on a scale
Standard Deviation 0.8
|
|
Investigator's Global Improvement Assessment for the Appearance of Coarse Lines/Wrinkles (Forehead, Periocular, Cheeks, Perioral Areas Individually Assessed)
Week 12 (Cheeks)
|
0.9 score on a scale
Standard Deviation 0.8
|
|
Investigator's Global Improvement Assessment for the Appearance of Coarse Lines/Wrinkles (Forehead, Periocular, Cheeks, Perioral Areas Individually Assessed)
Week 12 (Perioral)
|
0.8 score on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Week 12Population: ITT Population included all enrolled participants who applied study treatment and completed one follow-up visit after test product was initiated.
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).
Outcome measures
| Measure |
Retinol Complex 0.5
n=23 Participants
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.
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|---|---|
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Investigator's Global Improvement Assessment for Tactile Roughness
|
1.3 score on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Week 12Population: 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.
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.
Outcome measures
| Measure |
Retinol Complex 0.5
n=23 Participants
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.
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|---|---|
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Change From Baseline in Spectrophotometer L* Value (a Measurement of Skin Brightness)
Baseline (Normal Skin)
|
62.0 score on a scale
Standard Error 3.7
|
|
Change From Baseline in Spectrophotometer L* Value (a Measurement of Skin Brightness)
Change from BL at Week 12 (Normal Skin)
|
0.3 score on a scale
Standard Error 1.8
|
|
Change From Baseline in Spectrophotometer L* Value (a Measurement of Skin Brightness)
Baseline (Target Lesion)
|
57.8 score on a scale
Standard Error 5.7
|
|
Change From Baseline in Spectrophotometer L* Value (a Measurement of Skin Brightness)
Change from BL at Week 12 (Target Lesion)
|
0.3 score on a scale
Standard Error 1.7
|
Adverse Events
Retinol Complex 0.5
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Retinol Complex 0.5
n=23 participants at risk
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.
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|---|---|
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Skin and subcutaneous tissue disorders
Burning sensation
|
21.7%
5/23 • First study treatment application up to 12 weeks
Enrolled Population was used to determine the number of participants at risk for All-Cause Mortality. Safety Population, all enrolled participants who applied the test product, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Acne
|
8.7%
2/23 • First study treatment application up to 12 weeks
Enrolled Population was used to determine the number of participants at risk for All-Cause Mortality. Safety Population, all enrolled participants who applied the test product, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
17.4%
4/23 • First study treatment application up to 12 weeks
Enrolled Population was used to determine the number of participants at risk for All-Cause Mortality. Safety Population, all enrolled participants who applied the test product, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
21.7%
5/23 • First study treatment application up to 12 weeks
Enrolled Population was used to determine the number of participants at risk for All-Cause Mortality. Safety Population, all enrolled participants who applied the test product, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Rash
|
17.4%
4/23 • First study treatment application up to 12 weeks
Enrolled Population was used to determine the number of participants at risk for All-Cause Mortality. Safety Population, all enrolled participants who applied the test product, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
8.7%
2/23 • First study treatment application up to 12 weeks
Enrolled Population was used to determine the number of participants at risk for All-Cause Mortality. Safety Population, all enrolled participants who applied the test product, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
8.7%
2/23 • First study treatment application up to 12 weeks
Enrolled Population was used to determine the number of participants at risk for All-Cause Mortality. Safety Population, all enrolled participants who applied the test product, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place