Acne Vulgaris, Pediatrics
Conditions
Keywords
Acne Vulgaris, Doxycycline, Sub-Antimicrobial, Pediatrics
Brief summary
Antibiotic resistance is a public health problem that worsens the more physicians prescribe standard dose antibiotics for acne. Regardless of race, acne vulgaris is one of the most common dermatologic conditions among pediatric populations. As such, clinicians can make a large impact by practicing good antibiotic stewardship while still addressing the impact of acne on adolescents' self-esteem. Subantimicrobial doxycycline maintains its anti-inflammatory effects while eliminating antimicrobial properties and associated risks of drug resistance. Few studies, focused primarily on adults, have shown that subantimicrobial doxycycline is efficacious in treating acne from a physician standpoint. The investigators aim to investigate the patient experience of acne treatment with subantimicrobial dose doxycycline in the pediatric population.
Interventions
100 mg vs 20 mg doxycycline hyclate BID for 12 weeks
Sponsors
Michigan State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* Documented moderate to severe facial acne
Exclusion criteria
* Other skin conditions on the face * Previous antibiotic treatment for acne * Use of antibiotics for any reason within the past month * Use of new prescription regiment for acne within the last 3 months * Positive pregnancy test in the clinic * Cognitive impairments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Perceptions of Their Acne Treatment | 12 weeks | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Side Effects | 12 weeks | Any side effects associated with taking doxycycline for acne is encouraged to be discussed with the clinician |
| Changes in Medication, Open Comments in the Qualtrics Survey Regarding Acne Treatment | 12 weeks | Participants are invited to report any medication changes and submit open-ended comments concerning their use of doxycycline or their acne experiences. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 100 mg Standard Dose Doxycycline BID Oral, 12 weeks
Doxycycline Hyclate: 100 mg vs 20 mg doxycycline hyclate BID for 12 weeks | 11 |
| 20 mg Sub-antimicrobial Dose Doxycycline BID Oral, 12 weeks
Doxycycline Hyclate: 100 mg vs 20 mg doxycycline hyclate BID for 12 weeks | 11 |
| Total | 22 |
Baseline characteristics
| Characteristic | 20 mg Sub-antimicrobial Dose Doxycycline BID | Total | 100 mg Standard Dose Doxycycline BID |
|---|---|---|---|
| Age, Categorical <=18 years | 11 Participants | 22 Participants | 11 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 11 participants | 22 participants | 11 participants |
| Sex: Female, Male Female | 4 Participants | 11 Participants | 7 Participants |
| Sex: Female, Male Male | 7 Participants | 11 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 11 |
| other Total, other adverse events | 1 / 11 | 1 / 11 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 |
Outcome results
Primary
Patient Perceptions of Their Acne Treatment
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
Time frame: 12 weeks
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 6 (D) | 7 score on a scale |
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 6 (F) | 5 score on a scale |
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 10 (B) | 3 score on a scale |
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 8 (F) | 5 score on a scale |
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 12 (B) | 2 score on a scale |
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 10 (F) | 4 score on a scale |
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 0 (C) | 7 score on a scale |
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 12 (F) | 5 score on a scale |
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 0 (G) | 5 score on a scale |
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 8 (A) | 8 score on a scale |
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 2 (G) | 3 score on a scale |
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 2 (D) | 8 score on a scale |
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 4 (G) | 3 score on a scale |
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 2 (C) | 6 score on a scale |
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 6 (G) | 4 score on a scale |
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 0 (A) | 8 score on a scale |
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 8 (G) | 5 score on a scale |
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 4 (C) | 5 score on a scale |
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 10 (G) | 3 score on a scale |
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 6 (C) | 3 score on a scale |
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 12 (G) | 2 score on a scale |
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 4 (D) | 8 score on a scale |
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 0 (H) | 8 score on a scale |
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 8 (C) | 3 score on a scale |
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 2 (H) | 7 score on a scale |
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 2 (A) | 7 score on a scale |
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 6 (H) | 7 score on a scale |
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 10 (C) | 3 score on a scale |
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 8 (H) | 7 score on a scale |
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 0 (B) | 8 score on a scale |
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 10 (H) | 6 score on a scale |
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 4 (H) | 8 score on a scale |
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 12 (H) | 7 score on a scale |
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 8 (D) | 7 score on a scale |
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 12 (D) | 6 score on a scale |
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 2 (I) | 5 score on a scale |
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 0 (E) | 8 score on a scale |
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 4 (I) | 3 score on a scale |
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 2 (B) | 8 score on a scale |
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 6 (I) | 3 score on a scale |
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 2 (E) | 6 score on a scale |
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 8 (I) | 2 score on a scale |
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 4 (A) | 8 score on a scale |
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 10 (I) | 2 score on a scale |
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 4 (E) | 4 score on a scale |
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 12 (I) | 2 score on a scale |
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 6 (E) | 0 score on a scale |
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 0 (J) | 8 score on a scale |
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 4 (B) | 6 score on a scale |
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 2 (J) | 7 score on a scale |
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 8 (E) | 8 score on a scale |
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 4 (J) | 6 score on a scale |
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 0 (D) | 8 score on a scale |
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 6 (J) | 7 score on a scale |
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 8 (J) | 6 score on a scale |
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 12 (J) | 5 score on a scale |
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 6 (B) | 5 score on a scale |
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 6 (A) | 9 score on a scale |
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 0 (F) | 6 score on a scale |
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 8 (B) | 5 score on a scale |
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 2 (F) | 5 score on a scale |
| 100 mg Standard Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 4 (F) | 5 score on a scale |
| 20 mg Sub-antimicrobial Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 2 (G) | 6 score on a scale |
| 20 mg Sub-antimicrobial Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 2 (D) | 7 score on a scale |
| 20 mg Sub-antimicrobial Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 4 (D) | 8 score on a scale |
| 20 mg Sub-antimicrobial Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 2 (H) | 6 score on a scale |
| 20 mg Sub-antimicrobial Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 0 (D) | 7 score on a scale |
| 20 mg Sub-antimicrobial Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 0 (A) | 8 score on a scale |
| 20 mg Sub-antimicrobial Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 2 (A) | 7 score on a scale |
| 20 mg Sub-antimicrobial Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 4 (A) | 7 score on a scale |
| 20 mg Sub-antimicrobial Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 6 (A) | 6 score on a scale |
| 20 mg Sub-antimicrobial Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 8 (A) | 7 score on a scale |
| 20 mg Sub-antimicrobial Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 10 (A) | 4 score on a scale |
| 20 mg Sub-antimicrobial Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 12 (A) | 4 score on a scale |
| 20 mg Sub-antimicrobial Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 0 (B) | 6 score on a scale |
| 20 mg Sub-antimicrobial Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 2 (B) | 7 score on a scale |
| 20 mg Sub-antimicrobial Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 4 (B) | 6 score on a scale |
| 20 mg Sub-antimicrobial Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 6 (B) | 5 score on a scale |
| 20 mg Sub-antimicrobial Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 8 (B) | 6 score on a scale |
| 20 mg Sub-antimicrobial Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 0 (C) | 6 score on a scale |
| 20 mg Sub-antimicrobial Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 2 (C) | 6 score on a scale |
| 20 mg Sub-antimicrobial Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 6 (C) | 4 score on a scale |
| 20 mg Sub-antimicrobial Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 8 (C) | 4 score on a scale |
| 20 mg Sub-antimicrobial Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 10 (C) | 3 score on a scale |
| 20 mg Sub-antimicrobial Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 12 (C) | 4 score on a scale |
| 20 mg Sub-antimicrobial Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 0 (E) | 6 score on a scale |
| 20 mg Sub-antimicrobial Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 2 (E) | 6 score on a scale |
| 20 mg Sub-antimicrobial Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 6 (E) | 6 score on a scale |
| 20 mg Sub-antimicrobial Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 8 (E) | 5 score on a scale |
| 20 mg Sub-antimicrobial Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 10 (E) | 5 score on a scale |
| 20 mg Sub-antimicrobial Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 12 (E) | 5 score on a scale |
| 20 mg Sub-antimicrobial Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 0 (F) | 7 score on a scale |
| 20 mg Sub-antimicrobial Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 4 (F) | 7 score on a scale |
| 20 mg Sub-antimicrobial Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 6 (F) | 6 score on a scale |
| 20 mg Sub-antimicrobial Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 8 (F) | 7 score on a scale |
| 20 mg Sub-antimicrobial Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 10 (F) | 4 score on a scale |
| 20 mg Sub-antimicrobial Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 0 (G) | 6 score on a scale |
| 20 mg Sub-antimicrobial Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 4 (G) | 6 score on a scale |
| 20 mg Sub-antimicrobial Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 6 (G) | 7 score on a scale |
| 20 mg Sub-antimicrobial Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 8 (G) | 7 score on a scale |
| 20 mg Sub-antimicrobial Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 10 (G) | 6 score on a scale |
| 20 mg Sub-antimicrobial Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 12 (G) | 5 score on a scale |
| 20 mg Sub-antimicrobial Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 0 (H) | 7 score on a scale |
| 20 mg Sub-antimicrobial Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 4 (H) | 5 score on a scale |
| 20 mg Sub-antimicrobial Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 6 (H) | 4 score on a scale |
| 20 mg Sub-antimicrobial Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 8 (H) | 3 score on a scale |
| 20 mg Sub-antimicrobial Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 10 (H) | 2 score on a scale |
| 20 mg Sub-antimicrobial Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 12 (H) | 2 score on a scale |
| 20 mg Sub-antimicrobial Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 0 (I) | 6 score on a scale |
| 20 mg Sub-antimicrobial Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 2 (I) | 4 score on a scale |
| 20 mg Sub-antimicrobial Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 4 (I) | 6 score on a scale |
| 20 mg Sub-antimicrobial Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 6 (I) | 4 score on a scale |
| 20 mg Sub-antimicrobial Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 8 (I) | 5 score on a scale |
| 20 mg Sub-antimicrobial Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 10 (I) | 4 score on a scale |
| 20 mg Sub-antimicrobial Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 12 (I) | 3 score on a scale |
| 20 mg Sub-antimicrobial Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 0 (J) | 9 score on a scale |
| 20 mg Sub-antimicrobial Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 2 (J) | 10 score on a scale |
| 20 mg Sub-antimicrobial Dose Doxycycline BID | Patient Perceptions of Their Acne Treatment | Week 4 (J) | 8 score on a scale |
p-value: 0.677Chi-squared
p-value: 0.002Friedman's test
p-value: 0.018Fried
Other Pre-specified
Changes in Medication, Open Comments in the Qualtrics Survey Regarding Acne Treatment
Participants are invited to report any medication changes and submit open-ended comments concerning their use of doxycycline or their acne experiences.
Time frame: 12 weeks
Other Pre-specified
Side Effects
Any side effects associated with taking doxycycline for acne is encouraged to be discussed with the clinician
Time frame: 12 weeks