Trial Outcomes & Findings for Benzac 5% Gel in Combination With Cosmetic Products in Acne Vulgaris (NCT NCT02589405)
NCT ID: NCT02589405
Last Updated: 2021-02-18
Results Overview
Number of subjects satisfied and very satisfied with the three-part treatment regimen
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
50 participants
Primary outcome timeframe
12 weeks
Results posted on
2021-02-18
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
46
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Three-part Treatment Regimen
n=50 Participants
Subject received a treatment regimen comprising Benzaknen® 5% Gel in association with Dermotivin® Soft Liquid cleanser and Cetaphil® Dermacontrol Moisturizer SPF30
|
|---|---|
|
Age, Categorical
<=18 years
|
21 Participants
n=50 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=50 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=50 Participants
|
|
Age, Continuous
|
21.8 years
STANDARD_DEVIATION 8 • n=50 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=50 Participants
|
|
Region of Enrollment
Germany
|
50 Participants
n=50 Participants
|
|
Skin phototype
Phototype I
|
1 Participants
n=50 Participants
|
|
Skin phototype
Phototype II
|
25 Participants
n=50 Participants
|
|
Skin phototype
Phototype III
|
21 Participants
n=50 Participants
|
|
Skin phototype
Phototype IV
|
3 Participants
n=50 Participants
|
|
Investigator Global Assessment
Mild
|
37 Participants
n=50 Participants
|
|
Investigator Global Assessment
Moderate
|
13 Participants
n=50 Participants
|
|
Investigator Global Assessment
Severe
|
0 Participants
n=50 Participants
|
|
Acne duration
|
9.8 Years
STANDARD_DEVIATION 7.4 • n=50 Participants
|
|
Total lesion count
|
97 Lesion
STANDARD_DEVIATION 45.6 • n=50 Participants
|
|
Non-Inflammatory lesions
|
68.1 Lesions
STANDARD_DEVIATION 37.2 • n=50 Participants
|
|
Inflammatory lesions
|
28.9 Lesions
STANDARD_DEVIATION 21.7 • n=50 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Only Data Observed: All subjects that answered this question (which explains the discrepancy with the total number of participants) -
Number of subjects satisfied and very satisfied with the three-part treatment regimen
Outcome measures
| Measure |
Treatment Regimen
n=48 Participants
Subjects treated with the three-part treatment regimen comprising Benzaknen® 5% Gel in association with Dermotivin® Soft Liquid cleanser and Cetaphil® Dermacontrol Moisturizer SPF30
|
|---|---|
|
Number of Participants Satisfied and Very Satisfied With Regimen
|
42 participants
|
Adverse Events
Three-part Treatment Regimen
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Three-part Treatment Regimen
n=50 participants at risk
Subjects treated with the three-part treatment regimen comprising Benzaknen® 5% Gel in association with Dermotivin® Soft Liquid cleanser and Cetaphil® Dermacontrol Moisturizer SPF30
|
|---|---|
|
Immune system disorders
Hypersensitivity
|
2.0%
1/50 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
2.0%
1/50 • Number of events 1
|
Other adverse events
| Measure |
Three-part Treatment Regimen
n=50 participants at risk
Subjects treated with the three-part treatment regimen comprising Benzaknen® 5% Gel in association with Dermotivin® Soft Liquid cleanser and Cetaphil® Dermacontrol Moisturizer SPF30
|
|---|---|
|
Injury, poisoning and procedural complications
Laceration
|
2.0%
1/50 • Number of events 1
|
|
Injury, poisoning and procedural complications
Radius fracture
|
2.0%
1/50 • Number of events 1
|
|
Immune system disorders
Blepharitis
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
1/50 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Acne
|
2.0%
1/50 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.0%
1/50 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
2.0%
1/50 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
6.0%
3/50 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
2.0%
1/50 • Number of events 1
|
|
Infections and infestations
Herpes simplex
|
2.0%
1/50 • Number of events 1
|
|
Infections and infestations
Impetigo
|
2.0%
1/50 • Number of events 1
|
|
Infections and infestations
Mucosal infection
|
2.0%
1/50 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
8.0%
4/50 • Number of events 4
|
|
Infections and infestations
Pharyngitis
|
2.0%
1/50 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60