Acne Vulgaris
Conditions
Brief summary
The aim of this study is to evaluate a complete acne regimen consisting of a medication (Benzaknen® 5% Gel), and 2 cosmetic products Dermotivin® Soft Liquid soap and Cetaphil® Dermacontrol Moisturizer SPF30 in patients with acne.
Detailed description
The main objective of this study is to evaluate subject satisfaction with the treatment regimen comprising Benzaknen® 5% Gel in association with 2 cosmetic products including a foam soap, Dermotivin® Soft Liquid soap, and a non comedogenic moisturizer, Cetaphil® Dermacontrol Moisturizer SPF30, in patients with mild to moderate acne, after 12 weeks of treatment.
Interventions
DRUGBenzoyl Peroxide
OTHERDermotivin® Soft Liquid cleanser
OTHERCetaphil® Dermacontrol Moisturizer SPF30
Sponsors
Proinnovera GmbH
Galderma R&D
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female subject of any ethnic background of 12 years or older. * Subject with mild or moderate facial acne vulgaris defined as an Investigator Global Assessment (IGA) score at 2 or 3 on a 0-4 scale. * Subject with any skin phototype according to T.B. Fitzpatrick skin phototype definitions.
Exclusion criteria
* Subject with severe acne (IGA\>3) with nodules, cysts, scars or extra-facial lesions, * Female subject who is pregnant, lactating or planning a pregnancy during the study, * Subject susceptible to take a corticosteroid treatment during the study except inhaled or topic when needed to treat a condition outside the face,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Satisfied and Very Satisfied With Regimen | 12 weeks | Number of subjects satisfied and very satisfied with the three-part treatment regimen |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Three-part Treatment Regimen Subject received a treatment regimen comprising Benzaknen® 5% Gel in association with Dermotivin® Soft Liquid cleanser and Cetaphil® Dermacontrol Moisturizer SPF30 | 50 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Three-part Treatment Regimen | — |
|---|---|---|
| Acne duration | 9.8 Years STANDARD_DEVIATION 7.4 | — |
| Age, Categorical <=18 years | 21 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 29 Participants | — |
| Age, Continuous | 21.8 years STANDARD_DEVIATION 8 | — |
| Inflammatory lesions | 28.9 Lesions STANDARD_DEVIATION 21.7 | — |
| Investigator Global Assessment Mild | 37 Participants | — |
| Investigator Global Assessment Moderate | 13 Participants | — |
| Investigator Global Assessment Severe | 0 Participants | — |
| Non-Inflammatory lesions | 68.1 Lesions STANDARD_DEVIATION 37.2 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Germany | 50 Participants | — |
| Sex: Female, Male Female | 33 Participants | — |
| Sex: Female, Male Male | 17 Participants | — |
| Skin phototype Phototype I | 1 Participants | — |
| Skin phototype Phototype II | 25 Participants | — |
| Skin phototype Phototype III | 21 Participants | — |
| Skin phototype Phototype IV | 3 Participants | — |
| Total lesion count | 97 Lesion STANDARD_DEVIATION 45.6 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 50 |
| other Total, other adverse events | 13 / 50 |
| serious Total, serious adverse events | 1 / 50 |
Outcome results
Primary
Number of Participants Satisfied and Very Satisfied With Regimen
Number of subjects satisfied and very satisfied with the three-part treatment regimen
Time frame: 12 weeks
Population: Only Data Observed: All subjects that answered this question (which explains the discrepancy with the total number of participants) -
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Regimen | Number of Participants Satisfied and Very Satisfied With Regimen | 42 participants |