Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a single-center study, randomized, Investigator/Evaluator-blinded bilateral (split-face) comparison.
The objective: To assess the benefit of the concomitant use of a Moisturizing Lotion in reducing the skin irritation induced by a adapalen gel treatment in Chinese Subjects.
The interest & relevance of the concomitant use of a non-comedogenic moisturizer in order to decrease retinoid irritation has already been demonstrated in Caucasian patients. Such interest of associating a moisturizer when Differin® gel is prescribed has not been demonstrated in Asian populations.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intra-individual comparison | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adapalen 0.1% | Drug | Intra-individual (split-face) comparison: Differin® 0.1% (whole face) will be applied once daily for 4 weeks. Visits will be conducted weekly for a maximum of 5 visits. |
| Measure | Description | Time Frame |
|---|---|---|
| Erythema Rating Scale | score from 0 (none) to 3 (severe) | at 4 weeks |
| Scaling | score from 0 (none) to 3 (severe) | at 4 weeks |
| Dryness | score from 0 (none) to 3 (severe) | at 4 weeks |
| Stinging/Burning | score from 0 (none) to 3 (severe) | at 4 weeks |
| Pruritus | score from 0 (none) to 3 (severe) | at 4 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dr LEOW | National Skin Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| national Skin Center | Singapore | Singapore |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Intra-individual Comparison | Differin applied once daily (evening) on the whole face Cetaphil applied once daily (morning) on 1 side of the face |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Cetaphil® | Other | Intra-individual (split-face) comparison: Cetaphil® (only one side of the face) will be applied once daily for 4 weeks. Visits will be conducted weekly for a maximum of 5 visits. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Intra-individual Comparison | Differin applied once daily (evening) on the whole face Cetaphil applied once daily (morning) on 1 side of the face |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Erythema Rating Scale | score from 0 (none) to 3 (severe) | safety population (APT) | Posted | Mean | Standard Error | units on a scale | at 4 weeks |
|
|
| ||||||||||||||||||||||||||||
| Primary | Scaling | score from 0 (none) to 3 (severe) | safety population (APT) | Posted | Mean | Standard Error | units on a scale | at 4 weeks |
|
| |||||||||||||||||||||||||||||
| Primary | Dryness | score from 0 (none) to 3 (severe) | safety population (APT) | Posted | Mean | Standard Error | units on a scale | at 4 weeks |
|
| |||||||||||||||||||||||||||||
| Primary | Stinging/Burning | score from 0 (none) to 3 (severe) | safety population (APT) | Posted | Mean | Standard Error | units on a scale | at 4 weeks |
|
| |||||||||||||||||||||||||||||
| Primary | Pruritus | score from 0 (none) to 3 (severe) | safety population (APT) | Posted | Mean | Standard Error | units on a scale | at 4 weeks |
|
|
4 weeks
All medical clinical events occurred after subject's consent signature and during the study, whether observed by the Evaluator/Injector or reported by the Subject and whether or not thought to be treatment-related were considered adverse events and collected.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cetaphil + Differin | intra-individual comparison | 0 | 30 | 10 | 30 | ||
| EG001 | Differin Alone | intra-individual comparison | 0 | 30 | 10 | 30 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| dermatitis acneiform | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| excoriation | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| scab | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| skin exfoliation | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| upper respiratory tract infection | Infections and infestations | Systematic Assessment |
|
Any intent of the investigator to publish or disclose in any way the information requires the sponsor's prior written approval. The investigator shall provide their draft of such publication to sponsor for review and approval at least 2 months prior to the date of the intended publication. Sponsor shall have the absolute right to determine whether information may be published by the investigator.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Florence Paliargues | Galderma | 0033 4 92 95 29 57 | Florence.Paliargues@Galderma.com |
| ID | Term |
|---|---|
| C011189 | cetyl alcohol, propylene glycol, sodium lauryl sulfate non-lipid cleansing lotion |
Not provided
Not provided
Not provided
|
|
|
|