Trial Outcomes & Findings for Safety and Efficacy of Quadriderme® in the Treatment of Impetiginous Eczema (Study P05134AM4) (NCT NCT00671528)
NCT ID: NCT00671528
Last Updated: 2022-02-09
Results Overview
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
TERMINATED
PHASE4
3 participants
Days 1 (prior to start of treatment), 8, 15, 21, and 28.
2022-02-09
Participant Flow
Due to lack of recruitment, the study was terminated early. Only 3 participants of the anticipated 207 participants were enrolled.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
1
|
|
Overall Study
COMPLETED
|
1
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of Quadriderme® in the Treatment of Impetiginous Eczema (Study P05134AM4)
Baseline characteristics by cohort
| Measure |
Quadriderme® Cream
n=1 Participants
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.
|
Betamethasone Diproprionate and Gentamicin Sulfate Cream
n=1 Participants
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.
|
Betamethasone Diproprionate Cream
n=1 Participants
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.
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
Between 18 and 65 years
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
1 participants
n=7 Participants
|
|
Age, Customized
>=65 years
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
0 participants
n=206 Participants
|
2 participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 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.
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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 28 daysThe speed of action, measured as the number of days required to achieve total remission of all signs and symptoms of the disease.
Outcome measures
| Measure |
Quadriderme® Cream
n=1 Participants
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.
|
Betamethasone Diproprionate and Gentamicin Sulfate Cream
n=1 Participants
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.
|
Betamethasone Diproprionate Cream
n=1 Participants
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.
|
|---|---|---|---|
|
Number of Days Required to Achieve Total Remission
|
15 Days
|
15 Days
|
8 Days
|
Adverse Events
Quadriderme® Cream
Betamethasone Diproprionate and Gentamicin Sulfate Cream
Betamethasone Diproprionate Cream
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Results disclosure agreements
- Principal investigator is a sponsor employee The principal investigators agree not to publish or publicly present any interim results of the study without prior written consent of the SPONSOR. The principal investigator further agrees to provide 45 days written notice to the sponsor prior to submission for publication or presentation to permit the SPONSOR to review copies of abstracts or manuscripts for publication which report any results of the study. The SPONSOR shall have the right to review and comment on any presentation.
- Publication restrictions are in place
Restriction type: OTHER