Trial Outcomes & Findings for Topical NanoDox® for Atopic Dermatitis (NCT NCT02910011)
NCT ID: NCT02910011
Last Updated: 2020-03-26
Results Overview
comparing dermatological scores of treated lesions vs non treated lesions and treated peri-lesional areas with non-treated non-lesional areas
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
23 participants
Primary outcome timeframe
up to 4 weeks of study drug use
Results posted on
2020-03-26
Participant Flow
23 were consented but 15 assigned to receive the intervention
Participant milestones
| Measure |
Topical Administration of Study Drug
2.5 grams of Nanodox 1% (doxycycline monohydrate hydrogel) will be applied topically to an indicated lesion daily for 28 days
Nanodox 1% (doxycycline monohydrate hydrogel): Subjects will be asked to apply NanoDOX® Hydrogel 1% daily for up to four weeks or until complete clearance whichever is sooner
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Topical Administration of Study Drug
2.5 grams of Nanodox 1% (doxycycline monohydrate hydrogel) will be applied topically to an indicated lesion daily for 28 days
Nanodox 1% (doxycycline monohydrate hydrogel): Subjects will be asked to apply NanoDOX® Hydrogel 1% daily for up to four weeks or until complete clearance whichever is sooner
|
|---|---|
|
Overall Study
Physician Decision
|
2
|
Baseline Characteristics
Topical NanoDox® for Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
Topical Administration of Study Drug
n=15 Participants
2.5 grams of Nanodox 1% (doxycycline monohydrate hydrogel) will be applied topically to an indicated lesion daily for 28 days
Nanodox 1% (doxycycline monohydrate hydrogel): Subjects will be asked to apply NanoDOX® Hydrogel 1% once daily at bedtime for up to four weeks or until complete clearance whichever is sooner
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
36.5 years
STANDARD_DEVIATION 16 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian/ Alaskan Native
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or OPI
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one Race
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=5 Participants
|
|
Baseline Investigator's Global Assessment "IGA" for Target Area
Clear
|
5 Participants
n=5 Participants
|
|
Baseline Investigator's Global Assessment "IGA" for Target Area
Almost Clear
|
1 Participants
n=5 Participants
|
|
Baseline Investigator's Global Assessment "IGA" for Target Area
Mild
|
9 Participants
n=5 Participants
|
|
Baseline Investigator's Global Assessment "IGA" for Target Area
Moderate
|
5 Participants
n=5 Participants
|
|
Baseline Investigator's Global Assessment "IGA" for Target Area
Severe
|
1 Participants
n=5 Participants
|
|
Baseline Investigator's Global Assessment "IGA" for Target Area
Not performed
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 4 weeks of study drug usePopulation: 0 pts with treatment related adverse events
comparing dermatological scores of treated lesions vs non treated lesions and treated peri-lesional areas with non-treated non-lesional areas
Outcome measures
| Measure |
Topical Administration of Study Drug
n=15 Participants
2.5 grams of Nanodox 1% (doxycycline monohydrate hydrogel) will be applied topically to an indicated lesion daily for 28 days
Nanodox 1% (doxycycline monohydrate hydrogel): Subjects will be asked to apply NanoDOX® Hydrogel 1% once daily at bedtime for up to four weeks or until complete clearance whichever is sooner
|
|---|---|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 4 weeks of study drug usePopulation: Number of patients with reduction in growth of skin flora including S.Aureus
(positive or negative), difference in number of growth (0 to 3+++)
Outcome measures
| Measure |
Topical Administration of Study Drug
n=15 Participants
2.5 grams of Nanodox 1% (doxycycline monohydrate hydrogel) will be applied topically to an indicated lesion daily for 28 days
Nanodox 1% (doxycycline monohydrate hydrogel): Subjects will be asked to apply NanoDOX® Hydrogel 1% once daily at bedtime for up to four weeks or until complete clearance whichever is sooner
|
|---|---|
|
Number of Participants With Reduction in Growth of Skin Flora Including S.Aureus
Reduction of Staph species
|
7 Participants
|
|
Number of Participants With Reduction in Growth of Skin Flora Including S.Aureus
Reduction of Other flora
|
2 Participants
|
|
Number of Participants With Reduction in Growth of Skin Flora Including S.Aureus
No growth or normal flora at V1
|
6 Participants
|
SECONDARY outcome
Timeframe: 4 weeks of topical therapy1 point reduction of IGA score in Target area pre-treatment compared to post treatment (v3)
Outcome measures
| Measure |
Topical Administration of Study Drug
n=15 Participants
2.5 grams of Nanodox 1% (doxycycline monohydrate hydrogel) will be applied topically to an indicated lesion daily for 28 days
Nanodox 1% (doxycycline monohydrate hydrogel): Subjects will be asked to apply NanoDOX® Hydrogel 1% once daily at bedtime for up to four weeks or until complete clearance whichever is sooner
|
|---|---|
|
Number of Participant With a Change in Investigator's Global Assessment (IGA) in Target Area
Reduction of 1 pt
|
6 Participants
|
|
Number of Participant With a Change in Investigator's Global Assessment (IGA) in Target Area
Reduction of </=2 pt
|
7 Participants
|
|
Number of Participant With a Change in Investigator's Global Assessment (IGA) in Target Area
no reduction in IGA
|
1 Participants
|
|
Number of Participant With a Change in Investigator's Global Assessment (IGA) in Target Area
Worsening of IGA
|
1 Participants
|
Adverse Events
Topical Administration of Study Drug
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Topical Administration of Study Drug
n=15 participants at risk
2.5 grams of Nanodox 1% (doxycycline monohydrate hydrogel) will be applied topically to an indicated lesion daily for 28 days
Nanodox 1% (doxycycline monohydrate hydrogel): Subjects will be asked to apply NanoDOX® Hydrogel 1% once daily at bedtime for up to four weeks or until complete clearance whichever is sooner
|
|---|---|
|
Skin and subcutaneous tissue disorders
eczema flare-requiring steroid systemic treatment
|
13.3%
2/15 • Number of events 2 • Adverse Events were collected over 18 months encompassing all 15 included patients receiving drug
2 subjects were withdrawn early for adverse event "eczema flare-requiring steroid systemic treatment". Other adverse events include upper respiratory infection (2 subjects) requiring treatment. All adverse events considered unlikely/ not related to study drug.
|
|
Respiratory, thoracic and mediastinal disorders
upper respiratory infection
|
13.3%
2/15 • Number of events 2 • Adverse Events were collected over 18 months encompassing all 15 included patients receiving drug
2 subjects were withdrawn early for adverse event "eczema flare-requiring steroid systemic treatment". Other adverse events include upper respiratory infection (2 subjects) requiring treatment. All adverse events considered unlikely/ not related to study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place