Trial Outcomes & Findings for Adapalene Gel 0.3% Versus Tretinoin 0.05% Emollient Cream for Treatment of Photodamage (NCT NCT00647556)
NCT ID: NCT00647556
Last Updated: 2022-08-01
Results Overview
Number of participants who improved (a decrease by at least one point) in Overall Integrated Assessment of Photodamage from baseline to week 24. Overall Integrated Assessment of Photodamage is a scale from 0 - 5 (0 = None, 1 = Minimal, 2 = Mild, 3 - Moderate, 4 = Severe and 5 = Very Severe) with 0 being best and 5 being worst.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
30 participants
Primary outcome timeframe
baseline to week 24
Results posted on
2022-08-01
Participant Flow
Dates of recruitment period: First subject was enrolled on June 17, 2008 and the last subject was enrolled on July 24, 2009.
Wash-out period at baseline: 2 wks topical alpha-hydroxy, glycolic, salicylic, lactic, \& beta-hydroxy acids, topical vitamin A, ascorbic acid, vitamin E, corticosteroids on face; 4 wks systemic corticosteroids; 3 mos topical retinoids, superficial chemical peels/exfoliation/microdermabrasion; 6 mos botulinum toxin on the face; 1 yr oral retinoids.
Participant milestones
| Measure |
Differin® Gel, 0.3%
adapalene gel 0.3% - apply once daily in the evening for 24 weeks
|
Tretinoin Emollient Cream
Tretinoin Emollient Cream 0.05% - apply topically once daily in the evening for 24 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
12
|
13
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Differin® Gel, 0.3%
adapalene gel 0.3% - apply once daily in the evening for 24 weeks
|
Tretinoin Emollient Cream
Tretinoin Emollient Cream 0.05% - apply topically once daily in the evening for 24 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Surgery for pre-existing neck pain
|
1
|
0
|
Baseline Characteristics
Adapalene Gel 0.3% Versus Tretinoin 0.05% Emollient Cream for Treatment of Photodamage
Baseline characteristics by cohort
| Measure |
Differin® Gel, 0.3%
n=15 Participants
adapalene gel 0.3% - apply once daily in the evening for 24 weeks
|
Tretinoin Emollient Cream
n=15 Participants
Tretinoin Emollient Cream 0.05% - apply topically once daily in the evening for 24 weeks
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.9 years
STANDARD_DEVIATION 11.37 • n=93 Participants
|
61.3 years
STANDARD_DEVIATION 9.58 • n=4 Participants
|
61.1 years
STANDARD_DEVIATION 10.33 • n=27 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: baseline to week 24Population: ITT (Intent to Treat), LOCF (Last Observation Carried Forward)
Number of participants who improved (a decrease by at least one point) in Overall Integrated Assessment of Photodamage from baseline to week 24. Overall Integrated Assessment of Photodamage is a scale from 0 - 5 (0 = None, 1 = Minimal, 2 = Mild, 3 - Moderate, 4 = Severe and 5 = Very Severe) with 0 being best and 5 being worst.
Outcome measures
| Measure |
Differin® Gel, 0.3%
n=15 Participants
adapalene gel 0.3% - apply once daily in the evening for 24 weeks
|
Tretinoin Emollient Cream
n=15 Participants
Tretinoin Emollient Cream 0.05% - apply topically once daily in the evening for 24 weeks
|
|---|---|---|
|
Change From Baseline in Overall Integrated Assessment of Photodamage at Week 24
|
6 participants
|
10 participants
|
SECONDARY outcome
Timeframe: baseline, week 12 and week 24Population: ITT (Intent to Treat), LOCF (Last Observation Carried Forward)
Number of participants in each category of the Photonumeric Scale for the Assessment of Photodamage from baseline to week 12 and baseline to week 24. Photonumeric Scale consisted of 9 categories (Fine Wrinkling, Mottled Pigmentation, Irregular Depigmentation, Lentigines, Coarse Wrinkling, Elastosis, Tactile Roughness, Telangiectasia, and Actinic Keratosis. These were evaluated on a scale from 0 - 4 (0 = None, 1 = Minimal, 2 = Mild, 3 = Moderate and 4 = Severe) with 0 being best and 4 being worst.
Outcome measures
| Measure |
Differin® Gel, 0.3%
n=15 Participants
adapalene gel 0.3% - apply once daily in the evening for 24 weeks
|
Tretinoin Emollient Cream
n=15 Participants
Tretinoin Emollient Cream 0.05% - apply topically once daily in the evening for 24 weeks
|
|---|---|---|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Telangiectasia week 24 None (0)
|
0 participants
|
0 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Telangiectasia week 12 Moderate (3)
|
8 participants
|
5 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Tactile Roughness week 12 Mild (2)
|
5 participants
|
7 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Tactile Roughness week 12 Moderate (3)
|
0 participants
|
0 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Tactile Roughness week 12 Severe (4)
|
1 participants
|
1 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Tactile Roughness week 24 Minimal (1)
|
10 participants
|
11 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Tactile Roughness week 24 Mild (2)
|
4 participants
|
3 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Tactile Roughness week 24 Severe (4)
|
1 participants
|
0 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Telangiectasia baseline None (0)
|
0 participants
|
0 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Telangiectasia week 12 Severe (4)
|
1 participants
|
1 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Telangiectasia baseline Minimal (1)
|
0 participants
|
4 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Telangiectasia baseline Mild (2)
|
6 participants
|
5 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Telangiectasia baseline Moderate (3)
|
9 participants
|
4 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Telangiectasia week 12 Mild (2)
|
4 participants
|
5 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Telangiectasia week 24 Minimal (1)
|
3 participants
|
5 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Telangiectasia week 24 Mild (2)
|
4 participants
|
3 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Telangiectasia week 24 Moderate (3)
|
7 participants
|
6 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Telangiectasia week 24 Severe (4)
|
1 participants
|
1 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Actinic keratosis baseline None (0)
|
8 participants
|
9 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Actinic keratosis baseline Mild (2)
|
1 participants
|
1 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Actinic keratosis baseline Moderate (3)
|
1 participants
|
2 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Actinic keratosis week 12 None (0)
|
9 participants
|
9 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Actinic keratosis week 12 Minimal (1)
|
5 participants
|
4 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Actinic keratosis week 12 Mild (2)
|
0 participants
|
2 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Actinic keratosis week 12 Moderate (3)
|
0 participants
|
0 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Actinic keratosis week 12 Severe (4)
|
1 participants
|
0 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Actinic keratosis week 24 None (0)
|
12 participants
|
8 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Actinic keratosis week 24 Minimal (1)
|
2 participants
|
5 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Actinic keratosis week 24 Moderate (3)
|
0 participants
|
0 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Actinic keratosis week 24 Severe (4)
|
1 participants
|
0 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Fine wrinkling baseline None (0)
|
0 participants
|
0 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Fine wrinkling baseline Minimal (1)
|
0 participants
|
0 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Fine wrinkling baseline Mild (2)
|
3 participants
|
2 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Fine wrinkling baseline Moderate (3)
|
12 participants
|
11 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Fine wrinkling baseline Severe (4)
|
0 participants
|
2 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Fine wrinkling week 12 None (0)
|
0 participants
|
0 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Fine wrinkling week 12 Minimal (1)
|
1 participants
|
1 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Fine wrinkling week 12 Mild (2)
|
9 participants
|
4 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Fine wrinkling week 12 Moderate (3)
|
5 participants
|
9 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Fine wrinkling week 12 Severe (4)
|
0 participants
|
1 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Fine wrinkling week 24 None (0)
|
0 participants
|
1 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Fine wrinkling week 24 Minimal (1)
|
2 participants
|
2 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Fine wrinkling week 24 Mild (2)
|
8 participants
|
4 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Fine wrinkling week 24 Moderate (3)
|
5 participants
|
7 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Fine wrinkling week 24 Severe (4)
|
0 participants
|
1 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Mottled pigmentation baseline None (0)
|
0 participants
|
0 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Mottled pigmentation baseline Minimal (1)
|
0 participants
|
4 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Mottled pigmentation baseline Mild (2)
|
7 participants
|
8 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Mottled pigmentation baseline Moderate (3)
|
8 participants
|
2 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Mottled pigmentation baseline Severe (4)
|
0 participants
|
1 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Mottled pigmentation week 12 Minimal (1)
|
1 participants
|
7 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Mottled pigmentation week 12 Mild (2)
|
7 participants
|
5 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Mottled pigmentation week 12 Moderate (3)
|
6 participants
|
3 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Mottled pigmentation week 12 Severe (4)
|
1 participants
|
0 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Mottled pigmentation week 24 None (0)
|
1 participants
|
0 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Mottled pigmentation week 24 Minimal (1)
|
3 participants
|
10 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Mottled pigmentation week 24 Mild (2)
|
6 participants
|
4 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Irregular depigmentation baseline None (0)
|
1 participants
|
1 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Irregular depigmentation baseline Minimal (1)
|
5 participants
|
7 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Irregular depigmentation baseline Mild (2)
|
6 participants
|
5 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Irregular depigmentation baseline Moderate (3)
|
3 participants
|
2 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Irregular depigmentation baseline Severe (4)
|
0 participants
|
0 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Irregular depigmentation week 12 None (0)
|
1 participants
|
1 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Irregular depigmentation week 12 Minimal (1)
|
6 participants
|
9 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Irregular depigmentation week 12 Mild (2)
|
6 participants
|
4 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Irregular depigmentation week 12 Moderate (3)
|
2 participants
|
1 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Irregular depigmentation week 24 None (0)
|
1 participants
|
1 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Irregular depigmentation week 24 Minimal (1)
|
7 participants
|
9 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Irregular depigmentation week 24 Mild (2)
|
5 participants
|
5 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Irregular depigmentation week 24 Moderate (3)
|
2 participants
|
0 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Lentigines baseline None (0)
|
0 participants
|
0 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Lentigines baseline Minimal (1)
|
2 participants
|
3 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Lentigines baseline Moderate (3)
|
7 participants
|
2 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Lentigines baseline Severe (4)
|
1 participants
|
1 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Lentigines week 12 None (0)
|
0 participants
|
0 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Lentigines week 12 Minimal (1)
|
3 participants
|
5 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Lentigines week 12 Mild (2)
|
7 participants
|
9 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Lentigines week 12 Moderate (3)
|
5 participants
|
1 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Lentigines week 12 Severe (4)
|
0 participants
|
0 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Lentigines week 24 None (0)
|
1 participants
|
0 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Lentigines week 24 Minimal (1)
|
3 participants
|
7 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Lentigines week 24 Mild (2)
|
7 participants
|
7 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Lentigines week 24 Moderate (3)
|
4 participants
|
1 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Coarse wrinkling baseline None (0)
|
0 participants
|
0 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Coarse wrinkling baseline Minimal (1)
|
1 participants
|
0 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Coarse wrinkling baseline Mild (2)
|
10 participants
|
5 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Coarse wrinkling baseline Moderate (3)
|
2 participants
|
7 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Coarse wrinkling week 24 Minimal (1)
|
2 participants
|
2 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Coarse wrinkling week 24 Mild (2)
|
8 participants
|
6 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Coarse wrinkling week 24 Moderate (3)
|
3 participants
|
4 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Coarse wrinkling week 24 Severe (4)
|
2 participants
|
3 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Elastosis baseline None (0)
|
0 participants
|
0 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Elastosis baseline Minimal (1)
|
1 participants
|
1 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Elastosis baseline Mild (2)
|
7 participants
|
5 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Elastosis baseline Moderate (3)
|
6 participants
|
8 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Elastosis baseline Severe (4)
|
1 participants
|
1 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Elastosis week 12 None (0)
|
0 participants
|
0 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Elastosis week 12 Minimal (1)
|
1 participants
|
1 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Elastosis week 12 Mild (2)
|
9 participants
|
6 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Elastosis week 12 Moderate (3)
|
4 participants
|
7 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Elastosis week 12 Severe (4)
|
1 participants
|
1 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Elastosis week 24 Mild (2)
|
10 participants
|
8 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Tactile Roughness baseline None (0)
|
0 participants
|
1 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Tactile Roughness baseline Moderate (3)
|
4 participants
|
3 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Mottled pigmentation week 12 None (0)
|
0 participants
|
0 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Mottled pigmentation week 24 Moderate (3)
|
4 participants
|
1 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Mottled pigmentation week 24 Severe (4)
|
1 participants
|
0 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Irregular depigmentation week 12 Severe (4)
|
0 participants
|
0 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Irregular depigmentation week 24 Severe (4)
|
0 participants
|
0 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Lentigines baseline Mild (2)
|
5 participants
|
9 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Lentigines week 24 Severe (4)
|
0 participants
|
0 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Coarse wrinkling baseline Severe (4)
|
2 participants
|
3 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Coarse wrinkling week 12 None (0)
|
0 participants
|
0 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Coarse wrinkling week 12 Minimal (1)
|
2 participants
|
0 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Coarse wrinkling week 12 Mild (2)
|
9 participants
|
8 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Coarse wrinkling week 12 Moderate (3)
|
2 participants
|
4 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Coarse wrinkling week 12 Severe (4)
|
2 participants
|
3 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Coarse wrinkling week 24 None (0)
|
0 participants
|
0 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Elastosis week 24 None (0)
|
0 participants
|
0 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Elastosis week 24 Minimal (1)
|
2 participants
|
3 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Elastosis week 24 Moderate (3)
|
3 participants
|
3 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Elastosis week 24 Severe (4)
|
0 participants
|
1 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Tactile Roughness baseline Minimal (1)
|
7 participants
|
4 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Tactile Roughness baseline Mild (2)
|
3 participants
|
7 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Tactile Roughness baseline Severe (4)
|
1 participants
|
0 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Tactile Roughness week 12 None (0)
|
0 participants
|
1 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Tactile Roughness week 12 Minimal (1)
|
9 participants
|
6 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Tactile Roughness week 24 None (0)
|
0 participants
|
1 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Tactile Roughness week 24 Moderate (3)
|
0 participants
|
0 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Telangiectasia baseline Severe (4)
|
0 participants
|
2 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Telangiectasia week 12 None (0)
|
0 participants
|
0 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Telangiectasia week 12 Minimal (1)
|
2 participants
|
4 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Actinic keratosis baseline Minimal (1)
|
5 participants
|
3 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Actinic keratosis baseline Severe (4)
|
0 participants
|
0 participants
|
|
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
Actinic keratosis week 24 Mild (2)
|
0 participants
|
2 participants
|
SECONDARY outcome
Timeframe: baseline to week 12Population: ITT (Intent to Treat), LOCF (Last Observation Carried Forward)
Number of participants who improved in Overall Integrated Assessment of Photodamage from baseline to week 12. Overall Integrated Assessment of Photodamage was evaluated on a scale from 0 - 5 (0 = None, 1 = Minimal, 2 = Mild, 3 = Moderate 4 = Severe and 5 = Very Severe) with 0 being best and 5 being worst.
Outcome measures
| Measure |
Differin® Gel, 0.3%
n=15 Participants
adapalene gel 0.3% - apply once daily in the evening for 24 weeks
|
Tretinoin Emollient Cream
n=15 Participants
Tretinoin Emollient Cream 0.05% - apply topically once daily in the evening for 24 weeks
|
|---|---|---|
|
Number of Participants Who Improved (a Decrease of at Least One Point) in Overall Integrated Assessment of Photodamage From Baseline to Week 12.
|
6 participants
|
4 participants
|
SECONDARY outcome
Timeframe: week 12 and week 24Population: ITT (Intent to Treat; LOCF (Last Observation Carried Forward)
Number of participants in each category of the Subject Evaluation of Improvement at week 12 and week 24. Subject Evaluation of Improvement was evaluated on a scale from 0 - 6 (0 = Complete Improvement, 1 = Almost (\~90%) Improvement, 2 = Marked (\~75%) Improvement, 3 = Moderate (\~50%) Improvement, 4 = Slight (\~25%) Improvement, 5 = No Change, 6 = Worse) with 0 being best and 6 being worst.
Outcome measures
| Measure |
Differin® Gel, 0.3%
n=15 Participants
adapalene gel 0.3% - apply once daily in the evening for 24 weeks
|
Tretinoin Emollient Cream
n=15 Participants
Tretinoin Emollient Cream 0.05% - apply topically once daily in the evening for 24 weeks
|
|---|---|---|
|
Number of Participants in Each Category of the Subject Evaluation of Improvement at Week 12 and Week 24
week 12 Complete Improvement
|
0 participants
|
0 participants
|
|
Number of Participants in Each Category of the Subject Evaluation of Improvement at Week 12 and Week 24
week 12 Almost Complete Improvement
|
0 participants
|
0 participants
|
|
Number of Participants in Each Category of the Subject Evaluation of Improvement at Week 12 and Week 24
week 12 Marked Improvement
|
4 participants
|
2 participants
|
|
Number of Participants in Each Category of the Subject Evaluation of Improvement at Week 12 and Week 24
week 12 Moderate Improvement
|
4 participants
|
5 participants
|
|
Number of Participants in Each Category of the Subject Evaluation of Improvement at Week 12 and Week 24
week 12 Slight Improvement
|
4 participants
|
4 participants
|
|
Number of Participants in Each Category of the Subject Evaluation of Improvement at Week 12 and Week 24
week 12 No Change
|
0 participants
|
2 participants
|
|
Number of Participants in Each Category of the Subject Evaluation of Improvement at Week 12 and Week 24
week 12 Worse
|
0 participants
|
0 participants
|
|
Number of Participants in Each Category of the Subject Evaluation of Improvement at Week 12 and Week 24
week 12 Missing
|
3 participants
|
2 participants
|
|
Number of Participants in Each Category of the Subject Evaluation of Improvement at Week 12 and Week 24
week 24 Complete Improvement
|
0 participants
|
0 participants
|
|
Number of Participants in Each Category of the Subject Evaluation of Improvement at Week 12 and Week 24
week 24 Almost Complete Improvement
|
3 participants
|
1 participants
|
|
Number of Participants in Each Category of the Subject Evaluation of Improvement at Week 12 and Week 24
week 24 Marked Improvement
|
2 participants
|
4 participants
|
|
Number of Participants in Each Category of the Subject Evaluation of Improvement at Week 12 and Week 24
week 24 Moderate Improvement
|
4 participants
|
4 participants
|
|
Number of Participants in Each Category of the Subject Evaluation of Improvement at Week 12 and Week 24
week 24 Slight Improvement
|
3 participants
|
1 participants
|
|
Number of Participants in Each Category of the Subject Evaluation of Improvement at Week 12 and Week 24
week 24 No Change
|
0 participants
|
5 participants
|
|
Number of Participants in Each Category of the Subject Evaluation of Improvement at Week 12 and Week 24
week 24 Worse
|
0 participants
|
0 participants
|
|
Number of Participants in Each Category of the Subject Evaluation of Improvement at Week 12 and Week 24
week 24 Missing
|
3 participants
|
0 participants
|
SECONDARY outcome
Timeframe: week 12 and week 24Population: ITT (Intent to Treat), LOCF (Last Observation Carried Forward)
Number of participants in each category of the Investigator Evaluation of Global Response (Improvement) at week 12 and week 24. Investigator Evaluation of Global Response (Improvement) is evaluated on a scale from 0 - 6 (0 = Complete Response, 1 = Almost Complete (\~90%) Response, 2 = Marked (\~75%) Response, 3 = Moderate (\~50%) Response, 4 = Slight (\~25%) Response, 5 = No Response and 6 = Worsening) with 0 being best and 6 being worst.
Outcome measures
| Measure |
Differin® Gel, 0.3%
n=15 Participants
adapalene gel 0.3% - apply once daily in the evening for 24 weeks
|
Tretinoin Emollient Cream
n=15 Participants
Tretinoin Emollient Cream 0.05% - apply topically once daily in the evening for 24 weeks
|
|---|---|---|
|
Number of Participants in Each Category of the Investigator Evaluation of Global Response (Improvement) at Week 12 and Week 24
week 12 Complete Response
|
0 participants
|
0 participants
|
|
Number of Participants in Each Category of the Investigator Evaluation of Global Response (Improvement) at Week 12 and Week 24
week 12 Almost Complete Response
|
0 participants
|
0 participants
|
|
Number of Participants in Each Category of the Investigator Evaluation of Global Response (Improvement) at Week 12 and Week 24
week 12 Marked Response
|
0 participants
|
1 participants
|
|
Number of Participants in Each Category of the Investigator Evaluation of Global Response (Improvement) at Week 12 and Week 24
week 12 Moderate Response
|
2 participants
|
4 participants
|
|
Number of Participants in Each Category of the Investigator Evaluation of Global Response (Improvement) at Week 12 and Week 24
week 12 Slight Response
|
9 participants
|
6 participants
|
|
Number of Participants in Each Category of the Investigator Evaluation of Global Response (Improvement) at Week 12 and Week 24
week 12 No Response
|
1 participants
|
2 participants
|
|
Number of Participants in Each Category of the Investigator Evaluation of Global Response (Improvement) at Week 12 and Week 24
week 12 Worsening
|
0 participants
|
0 participants
|
|
Number of Participants in Each Category of the Investigator Evaluation of Global Response (Improvement) at Week 12 and Week 24
week 12 Missing
|
3 participants
|
2 participants
|
|
Number of Participants in Each Category of the Investigator Evaluation of Global Response (Improvement) at Week 12 and Week 24
week 24 Complete Response
|
0 participants
|
0 participants
|
|
Number of Participants in Each Category of the Investigator Evaluation of Global Response (Improvement) at Week 12 and Week 24
week 24 Almost Complete Response
|
0 participants
|
0 participants
|
|
Number of Participants in Each Category of the Investigator Evaluation of Global Response (Improvement) at Week 12 and Week 24
week 24 Marked Response
|
2 participants
|
0 participants
|
|
Number of Participants in Each Category of the Investigator Evaluation of Global Response (Improvement) at Week 12 and Week 24
week 24 Moderate Response
|
2 participants
|
8 participants
|
|
Number of Participants in Each Category of the Investigator Evaluation of Global Response (Improvement) at Week 12 and Week 24
week 24 Slight Response
|
6 participants
|
4 participants
|
|
Number of Participants in Each Category of the Investigator Evaluation of Global Response (Improvement) at Week 12 and Week 24
week 24 No Response
|
2 participants
|
3 participants
|
|
Number of Participants in Each Category of the Investigator Evaluation of Global Response (Improvement) at Week 12 and Week 24
week 24 Worsening
|
0 participants
|
0 participants
|
|
Number of Participants in Each Category of the Investigator Evaluation of Global Response (Improvement) at Week 12 and Week 24
week 24 Missing
|
3 participants
|
0 participants
|
Adverse Events
Differin® Gel, 0.3%
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Tretinoin Emollient Cream
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Differin® Gel, 0.3%
n=15 participants at risk
adapalene gel 0.3% - apply once daily in the evening for 24 weeks
|
Tretinoin Emollient Cream
n=15 participants at risk
Tretinoin Emollient Cream 0.05% - apply topically once daily in the evening for 24 weeks
|
|---|---|---|
|
General disorders
Application site bleeding
|
0.00%
0/15 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
6.7%
1/15 • Number of events 1 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
|
General disorders
Application site burn
|
6.7%
1/15 • Number of events 2 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
0.00%
0/15 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
|
General disorders
Application site dermatitis
|
0.00%
0/15 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
13.3%
2/15 • Number of events 3 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
|
General disorders
Application site irritation
|
6.7%
1/15 • Number of events 1 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
0.00%
0/15 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
|
General disorders
Application site reaction
|
6.7%
1/15 • Number of events 1 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
0.00%
0/15 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
|
Eye disorders
Eye pain
|
0.00%
0/15 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
6.7%
1/15 • Number of events 1 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
|
Eye disorders
Lacrimation increased
|
6.7%
1/15 • Number of events 1 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
13.3%
2/15 • Number of events 2 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/15 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
6.7%
1/15 • Number of events 1 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/15 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
6.7%
1/15 • Number of events 1 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/15 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
6.7%
1/15 • Number of events 1 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
|
Gastrointestinal disorders
Periodontitis
|
0.00%
0/15 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
6.7%
1/15 • Number of events 1 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/15 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
6.7%
1/15 • Number of events 1 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/15 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
6.7%
1/15 • Number of events 1 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
|
Infections and infestations
Chlamydial infection
|
0.00%
0/15 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
6.7%
1/15 • Number of events 1 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/15 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
6.7%
1/15 • Number of events 1 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/15 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
6.7%
1/15 • Number of events 1 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
|
Infections and infestations
Gonorrhea
|
0.00%
0/15 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
6.7%
1/15 • Number of events 1 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/15 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
13.3%
2/15 • Number of events 3 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
|
Infections and infestations
Nasopharyngitis
|
6.7%
1/15 • Number of events 1 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
6.7%
1/15 • Number of events 1 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/15 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
6.7%
1/15 • Number of events 1 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
|
Infections and infestations
Streptococcal postoperative wound infection
|
0.00%
0/15 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
6.7%
1/15 • Number of events 1 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/15 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
6.7%
1/15 • Number of events 1 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/15 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
6.7%
1/15 • Number of events 1 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
|
Infections and infestations
Upper respiratory tract infection
|
13.3%
2/15 • Number of events 2 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
6.7%
1/15 • Number of events 1 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/15 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
6.7%
1/15 • Number of events 1 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/15 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
6.7%
1/15 • Number of events 1 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
|
Injury, poisoning and procedural complications
Open wound
|
0.00%
0/15 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
6.7%
1/15 • Number of events 1 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/15 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
13.3%
2/15 • Number of events 3 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/15 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
6.7%
1/15 • Number of events 1 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
1/15 • Number of events 1 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
0.00%
0/15 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/15 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
6.7%
1/15 • Number of events 1 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/15 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
6.7%
1/15 • Number of events 1 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/15 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
6.7%
1/15 • Number of events 1 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/15 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
6.7%
1/15 • Number of events 1 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
|
Psychiatric disorders
Depression
|
0.00%
0/15 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
6.7%
1/15 • Number of events 1 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/15 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
6.7%
1/15 • Number of events 1 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
|
Renal and urinary disorders
Terminal dribbling
|
6.7%
1/15 • Number of events 1 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
0.00%
0/15 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/15 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
6.7%
1/15 • Number of events 1 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/15 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
6.7%
1/15 • Number of events 1 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
6.7%
1/15 • Number of events 1 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
0.00%
0/15 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/15 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
26.7%
4/15 • Number of events 4 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.7%
1/15 • Number of events 1 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
0.00%
0/15 • 24 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.
|
Additional Information
Ronald W. Gottschalk, MD / Medical Director
Galderma Laboratories, L.P.
Phone: 817-961-5358
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The principal investigator has the right to publish or present the data resulting from this study, with agreed upon reviews by all interested parties, and in accordance with any confidentiality agreements that may exist.
- Publication restrictions are in place
Restriction type: OTHER