Dermatitis, Atopic, Eczema, Atopic, Skin Diseases, Eczematous
Conditions
Keywords
Impetiginous
Brief summary
This is a parallel-group, randomized, active-controlled, double-blind, Phase 4 trial comparing three creams in the treatment of impetiginous eczema: * Arm A: QUADRIDERME® cream (betamethasone diproprionate, clotrimazole, and gentamicin sulfate) * Arm B: Combination of betamethasone diproprionate cream and gentamicin sulfate cream * Arm C: Betamethasone diproprionate cream At 7 sites, in Portugal, a total of 207 subjects will be randomized using a 1:1:1 randomization ratio to receive one of the three possible treatments for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days. Assessments will be made of level of improvement of the target area in each treatment group, number of days for total remission, and safety profile. Note: This study was terminated early due to lack of recruitment (only 3 of the 207 planned participants were enrolled). Statistical analyses were not performed. Further, 7 sites were planned, but only 4 sites were approved out of which 3 sites were initiated.
Interventions
DRUGCream (betamethasone diproprionate, clotrimazole, and gentamicin sulfate)
Betamethasone diproprionate 0.05%, clotrimazole 1%, and gentamicin sulfate 0.1% cream applied in a thin layer that covers the affected and surrounding area 2 times a day (BID), morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
DRUGCream (betamethasone diproprionate and gentamicin)
Betamethasone diproprionate 0.05% and gentamicin sulfate 0.1% cream applied in a thin layer that covers the affected and surrounding area BID, morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
DRUGCream (betamethasone diproprionate)
Betamethasone diproprionate 0.05% cream applied in a thin layer that covers the affected and surrounding area BID, morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Minimum age: 12 years * Good general health confirmed by clinical history and a physical and skin examination (excluding area of skin with impetiginous eczema). * Diagnosis of impetiginous eczema. * Ability to understand the procedures of the protocol and follow the requirements during the course of the study. * Results of routine laboratory tests - hemogram with leukogram and platelet count, creatinine, glucose, sed. rate, IgE level and transaminases; along with plasma cortisol and adrenocorticotropic hormone (ACTH) levels prior to the start of the treatment. These results must all be within normal limits or not clinically relevant in order to be included in the trial.
Exclusion criteria
* Pregnant participants or women of childbearing age who are not using birth control methods considered reliable by the attending physician. * Participants with a history of hypersensitivity to any of the components of the medication being studied. * Participants in whom the extent or severity of the lesions requires treatment of a different type than what is planned for this trial. * Participants who need any other type of topical or systemic medication during the trial that might affect the course of the disease. * Participants who have been treated with other topical medications during the 14-day period prior to the start of the trial. * Participants who have received systemic corticosteroids or any other immunosuppressant medication during the 28-day period prior to the start of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Improvement of Individually Measured Signs of the Disease | Days 1 (prior to start of treatment), 8, 15, 21, and 28. | Percent improvement of individually measured signs of the disease (erythema, vesiculation, scaling, pruritis) in a given target area that was chosen by the investigator was assessed objectively & quantified on a scale of 0-5 (0-absent, 5-very intense). Overall assessment reflected the changes in the disease & was carried out by the investigator. The following scale was used: 1. Cure- Complete remission 2. \> 75% reduction: Marked improvement 3. 50-75% reduction: Moderate improvement 4. 25-50% reduction: Slight improvement 5. \<25% reduction: Ineffectiveness 6. Worsening of signs & symptoms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Days Required to Achieve Total Remission | Up to 28 days | The speed of action, measured as the number of days required to achieve total remission of all signs and symptoms of the disease. |
Participant flow
Pre-assignment details
Due to lack of recruitment, the study was terminated early. Only 3 participants of the anticipated 207 participants were enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Quadriderme® Cream Combination of Betamethasone diproprionate 0.05%, clotrimazole 1%, and gentamicin sulfate 0.1% applied in a thin layer that covers the affected and surrounding area 2 times a day (BID), morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days. | 1 |
| Betamethasone Diproprionate and Gentamicin Sulfate Cream Combination of Betamethasone diproprionate 0.05% cream and gentamicin sulfate 0.1% applied in a thin layer that covers the affected and surrounding area BID, morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days. | 1 |
| Betamethasone Diproprionate Cream Betamethasone diproprionate 0.05% cream applied in a thin layer that covers the affected and surrounding area BID, morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days. | 1 |
| Total | 3 |
Baseline characteristics
| Characteristic | Total | Quadriderme® Cream | Betamethasone Diproprionate and Gentamicin Sulfate Cream | Betamethasone Diproprionate Cream |
|---|---|---|---|---|
| Age, Customized >=65 years | 2 participants | 1 participants | 1 participants | 0 participants |
| Age, Customized Between 18 and 65 years | 1 participants | 0 participants | 0 participants | 1 participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 1 | 0 / 1 | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 | 0 / 1 | 0 / 1 |
Outcome results
Primary
Percent Improvement of Individually Measured Signs of the Disease
Percent improvement of individually measured signs of the disease (erythema, vesiculation, scaling, pruritis) in a given target area that was chosen by the investigator was assessed objectively & quantified on a scale of 0-5 (0-absent, 5-very intense). Overall assessment reflected the changes in the disease & was carried out by the investigator. The following scale was used: 1. Cure- Complete remission 2. \> 75% reduction: Marked improvement 3. 50-75% reduction: Moderate improvement 4. 25-50% reduction: Slight improvement 5. \<25% reduction: Ineffectiveness 6. Worsening of signs & symptoms
Time frame: Days 1 (prior to start of treatment), 8, 15, 21, and 28.
Population: Due to lack of participant recruitment and therefore study termination, no analyses were performed.
Secondary
Number of Days Required to Achieve Total Remission
The speed of action, measured as the number of days required to achieve total remission of all signs and symptoms of the disease.
Time frame: Up to 28 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Quadriderme® Cream | Number of Days Required to Achieve Total Remission | 15 Days |
| Betamethasone Diproprionate and Gentamicin Sulfate Cream | Number of Days Required to Achieve Total Remission | 15 Days |
| Betamethasone Diproprionate Cream | Number of Days Required to Achieve Total Remission | 8 Days |