Trial Outcomes & Findings for Subantimicrobial Doxycycline in Acne (NCT NCT05399290)
NCT ID: NCT05399290
Last Updated: 2023-04-03
Results Overview
Biweekly Qualtrics surveys were administered to identify changes in the self-reported severity of facial acne lesions using a 10-point ordinal Likert-type scale at 7 post-prescription time point (week 0, week 2, week 4, week 6, week 8, week 10, week 12). The minimum value is 1 and the maximum value is 10, with increasing acne severity (i.e. 10 is most severe acne). * In the table below, participants are labelled by a letter (A, B, etc.) to differentiate the different time points (rows) but participants in each treatment group (100 mg vs 20 mg) are different and not related. * Data is missing for timepoints when surveys were not submitted
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
22 participants
Primary outcome timeframe
12 weeks
Results posted on
2023-04-03
Participant Flow
Participant milestones
| Measure |
100 mg Standard Dose Doxycycline BID
Oral, 12 weeks
Doxycycline Hyclate: 100 mg vs 20 mg doxycycline hyclate BID for 12 weeks
|
20 mg Sub-antimicrobial Dose Doxycycline BID
Oral, 12 weeks
Doxycycline Hyclate: 100 mg vs 20 mg doxycycline hyclate BID for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
100 mg Standard Dose Doxycycline BID
n=11 Participants
Oral, 12 weeks
Doxycycline Hyclate: 100 mg vs 20 mg doxycycline hyclate BID for 12 weeks
|
20 mg Sub-antimicrobial Dose Doxycycline BID
n=11 Participants
Oral, 12 weeks
Doxycycline Hyclate: 100 mg vs 20 mg doxycycline hyclate BID for 12 weeks
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
11 Participants
n=11 Participants
|
11 Participants
n=11 Participants
|
22 Participants
n=22 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=22 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=22 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=11 Participants
|
4 Participants
n=11 Participants
|
11 Participants
n=22 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=11 Participants
|
7 Participants
n=11 Participants
|
11 Participants
n=22 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
11 participants
n=11 Participants
|
11 participants
n=11 Participants
|
22 participants
n=22 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: 10 participants in each group were analyzed as they had fulfilled the requirement of submitting a minimum of 3 survey ratings out of 7 total (week 0, 2, 4, 6, 8, 10, 12). A total of 62 ratings were analyzed in the 100 mg treatment arm (i.e. there were 8 surveys not submitted among the 10 participants), and 56 ratings in the 20 mg treatment arm.
Biweekly Qualtrics surveys were administered to identify changes in the self-reported severity of facial acne lesions using a 10-point ordinal Likert-type scale at 7 post-prescription time point (week 0, week 2, week 4, week 6, week 8, week 10, week 12). The minimum value is 1 and the maximum value is 10, with increasing acne severity (i.e. 10 is most severe acne). * In the table below, participants are labelled by a letter (A, B, etc.) to differentiate the different time points (rows) but participants in each treatment group (100 mg vs 20 mg) are different and not related. * Data is missing for timepoints when surveys were not submitted
Outcome measures
| Measure |
100 mg Standard Dose Doxycycline BID
n=62 Survey Ratings
Oral, 12 weeks
Doxycycline Hyclate: 100 mg vs 20 mg doxycycline hyclate BID for 12 weeks
|
20 mg Sub-antimicrobial Dose Doxycycline BID
n=56 Survey Ratings
Oral, 12 weeks
Doxycycline Hyclate: 100 mg vs 20 mg doxycycline hyclate BID for 12 weeks
|
|---|---|---|
|
Patient Perceptions of Their Acne Treatment
Week 12 (H)
|
7 score on a scale
|
2 score on a scale
|
|
Patient Perceptions of Their Acne Treatment
Week 0 (I)
|
—
|
6 score on a scale
|
|
Patient Perceptions of Their Acne Treatment
Week 2 (I)
|
5 score on a scale
|
4 score on a scale
|
|
Patient Perceptions of Their Acne Treatment
Week 4 (I)
|
3 score on a scale
|
6 score on a scale
|
|
Patient Perceptions of Their Acne Treatment
Week 6 (I)
|
3 score on a scale
|
4 score on a scale
|
|
Patient Perceptions of Their Acne Treatment
Week 0 (A)
|
8 score on a scale
|
8 score on a scale
|
|
Patient Perceptions of Their Acne Treatment
Week 2 (A)
|
7 score on a scale
|
7 score on a scale
|
|
Patient Perceptions of Their Acne Treatment
Week 4 (A)
|
8 score on a scale
|
7 score on a scale
|
|
Patient Perceptions of Their Acne Treatment
Week 6 (A)
|
9 score on a scale
|
6 score on a scale
|
|
Patient Perceptions of Their Acne Treatment
Week 8 (A)
|
8 score on a scale
|
7 score on a scale
|
|
Patient Perceptions of Their Acne Treatment
Week 10 (A)
|
—
|
4 score on a scale
|
|
Patient Perceptions of Their Acne Treatment
Week 12 (A)
|
—
|
4 score on a scale
|
|
Patient Perceptions of Their Acne Treatment
Week 0 (B)
|
8 score on a scale
|
6 score on a scale
|
|
Patient Perceptions of Their Acne Treatment
Week 2 (B)
|
8 score on a scale
|
7 score on a scale
|
|
Patient Perceptions of Their Acne Treatment
Week 4 (B)
|
6 score on a scale
|
6 score on a scale
|
|
Patient Perceptions of Their Acne Treatment
Week 6 (B)
|
5 score on a scale
|
5 score on a scale
|
|
Patient Perceptions of Their Acne Treatment
Week 8 (B)
|
5 score on a scale
|
6 score on a scale
|
|
Patient Perceptions of Their Acne Treatment
Week 10 (B)
|
3 score on a scale
|
—
|
|
Patient Perceptions of Their Acne Treatment
Week 12 (B)
|
2 score on a scale
|
—
|
|
Patient Perceptions of Their Acne Treatment
Week 0 (C)
|
7 score on a scale
|
6 score on a scale
|
|
Patient Perceptions of Their Acne Treatment
Week 2 (C)
|
6 score on a scale
|
6 score on a scale
|
|
Patient Perceptions of Their Acne Treatment
Week 4 (C)
|
5 score on a scale
|
—
|
|
Patient Perceptions of Their Acne Treatment
Week 6 (C)
|
3 score on a scale
|
4 score on a scale
|
|
Patient Perceptions of Their Acne Treatment
Week 8 (C)
|
3 score on a scale
|
4 score on a scale
|
|
Patient Perceptions of Their Acne Treatment
Week 10 (C)
|
3 score on a scale
|
3 score on a scale
|
|
Patient Perceptions of Their Acne Treatment
Week 12 (C)
|
—
|
4 score on a scale
|
|
Patient Perceptions of Their Acne Treatment
Week 0 (D)
|
8 score on a scale
|
7 score on a scale
|
|
Patient Perceptions of Their Acne Treatment
Week 2 (D)
|
8 score on a scale
|
7 score on a scale
|
|
Patient Perceptions of Their Acne Treatment
Week 4 (D)
|
8 score on a scale
|
8 score on a scale
|
|
Patient Perceptions of Their Acne Treatment
Week 6 (D)
|
7 score on a scale
|
—
|
|
Patient Perceptions of Their Acne Treatment
Week 8 (D)
|
7 score on a scale
|
—
|
|
Patient Perceptions of Their Acne Treatment
Week 12 (D)
|
6 score on a scale
|
—
|
|
Patient Perceptions of Their Acne Treatment
Week 0 (E)
|
8 score on a scale
|
6 score on a scale
|
|
Patient Perceptions of Their Acne Treatment
Week 2 (E)
|
6 score on a scale
|
6 score on a scale
|
|
Patient Perceptions of Their Acne Treatment
Week 4 (E)
|
4 score on a scale
|
—
|
|
Patient Perceptions of Their Acne Treatment
Week 6 (E)
|
0 score on a scale
|
6 score on a scale
|
|
Patient Perceptions of Their Acne Treatment
Week 8 (E)
|
8 score on a scale
|
5 score on a scale
|
|
Patient Perceptions of Their Acne Treatment
Week 10 (E)
|
—
|
5 score on a scale
|
|
Patient Perceptions of Their Acne Treatment
Week 12 (E)
|
—
|
5 score on a scale
|
|
Patient Perceptions of Their Acne Treatment
Week 0 (F)
|
6 score on a scale
|
7 score on a scale
|
|
Patient Perceptions of Their Acne Treatment
Week 2 (F)
|
5 score on a scale
|
—
|
|
Patient Perceptions of Their Acne Treatment
Week 4 (F)
|
5 score on a scale
|
7 score on a scale
|
|
Patient Perceptions of Their Acne Treatment
Week 6 (F)
|
5 score on a scale
|
6 score on a scale
|
|
Patient Perceptions of Their Acne Treatment
Week 8 (F)
|
5 score on a scale
|
7 score on a scale
|
|
Patient Perceptions of Their Acne Treatment
Week 10 (F)
|
4 score on a scale
|
4 score on a scale
|
|
Patient Perceptions of Their Acne Treatment
Week 12 (F)
|
5 score on a scale
|
—
|
|
Patient Perceptions of Their Acne Treatment
Week 0 (G)
|
5 score on a scale
|
6 score on a scale
|
|
Patient Perceptions of Their Acne Treatment
Week 2 (G)
|
3 score on a scale
|
6 score on a scale
|
|
Patient Perceptions of Their Acne Treatment
Week 4 (G)
|
3 score on a scale
|
6 score on a scale
|
|
Patient Perceptions of Their Acne Treatment
Week 6 (G)
|
4 score on a scale
|
7 score on a scale
|
|
Patient Perceptions of Their Acne Treatment
Week 8 (G)
|
5 score on a scale
|
7 score on a scale
|
|
Patient Perceptions of Their Acne Treatment
Week 10 (G)
|
3 score on a scale
|
6 score on a scale
|
|
Patient Perceptions of Their Acne Treatment
Week 12 (G)
|
2 score on a scale
|
5 score on a scale
|
|
Patient Perceptions of Their Acne Treatment
Week 0 (H)
|
8 score on a scale
|
7 score on a scale
|
|
Patient Perceptions of Their Acne Treatment
Week 2 (H)
|
7 score on a scale
|
6 score on a scale
|
|
Patient Perceptions of Their Acne Treatment
Week 4 (H)
|
8 score on a scale
|
5 score on a scale
|
|
Patient Perceptions of Their Acne Treatment
Week 6 (H)
|
7 score on a scale
|
4 score on a scale
|
|
Patient Perceptions of Their Acne Treatment
Week 8 (H)
|
7 score on a scale
|
3 score on a scale
|
|
Patient Perceptions of Their Acne Treatment
Week 10 (H)
|
6 score on a scale
|
2 score on a scale
|
|
Patient Perceptions of Their Acne Treatment
Week 8 (I)
|
2 score on a scale
|
5 score on a scale
|
|
Patient Perceptions of Their Acne Treatment
Week 10 (I)
|
2 score on a scale
|
4 score on a scale
|
|
Patient Perceptions of Their Acne Treatment
Week 12 (I)
|
2 score on a scale
|
3 score on a scale
|
|
Patient Perceptions of Their Acne Treatment
Week 0 (J)
|
8 score on a scale
|
9 score on a scale
|
|
Patient Perceptions of Their Acne Treatment
Week 2 (J)
|
7 score on a scale
|
10 score on a scale
|
|
Patient Perceptions of Their Acne Treatment
Week 4 (J)
|
6 score on a scale
|
8 score on a scale
|
|
Patient Perceptions of Their Acne Treatment
Week 6 (J)
|
7 score on a scale
|
—
|
|
Patient Perceptions of Their Acne Treatment
Week 8 (J)
|
6 score on a scale
|
—
|
|
Patient Perceptions of Their Acne Treatment
Week 12 (J)
|
5 score on a scale
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksParticipants are invited to report any medication changes and submit open-ended comments concerning their use of doxycycline or their acne experiences.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksAny side effects associated with taking doxycycline for acne is encouraged to be discussed with the clinician
Outcome measures
Outcome data not reported
Adverse Events
100 mg Standard Dose Doxycycline BID
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
20 mg Sub-antimicrobial Dose Doxycycline BID
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
100 mg Standard Dose Doxycycline BID
n=11 participants at risk
Oral, 12 weeks
Doxycycline Hyclate: 100 mg vs 20 mg doxycycline hyclate BID for 12 weeks
|
20 mg Sub-antimicrobial Dose Doxycycline BID
n=11 participants at risk
Oral, 12 weeks
Doxycycline Hyclate: 100 mg vs 20 mg doxycycline hyclate BID for 12 weeks
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Photoallergic reaction
|
9.1%
1/11 • Number of events 1 • 12 weeks
|
0.00%
0/11 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
No Improvement
|
0.00%
0/11 • 12 weeks
|
9.1%
1/11 • Number of events 1 • 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place