A Phase 4 interventional study of Doxycycline Hyclate in Acne Vulgaris and Pediatrics, sponsored by Michigan State University. Completed at 1 site in United States. Open to participants aged 13 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-03.
Sponsored by Michigan State University · Phase 4, Interventional, and Treatment
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.
730 studies on the registry are indexed under Acne Vulgaris; 86 are open to participants now.
This study's enrollment of 22 is below the median of 69 across 628 interventional studies indexed under Acne Vulgaris.
Browse Acne Vulgaris studies →Michigan State University is the lead sponsor of 139 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Oral, 12 weeks
Drug: Doxycycline Hyclate
Oral, 12 weeks
Drug: Doxycycline Hyclate
100 mg vs 20 mg doxycycline hyclate BID for 12 weeks
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
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
Side Effects
Any side effects associated with taking doxycycline for acne is encouraged to be discussed with the clinician
Time frame: 12 weeks
| Milestone | 100 mg Standard Dose Doxycycline BID | 20 mg Sub-antimicrobial Dose Doxycycline BID |
|---|---|---|
| Started | 11 | 11 |
| Completed | 10 | 10 |
| Not completed | 1 | 1 |
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
| score on a scale | 100 mg Standard Dose Doxycycline BID | 20 mg Sub-antimicrobial Dose Doxycycline BID |
|---|---|---|
| Week 0 (A) | 8 | 8 |
| Week 2 (A) | 7 | 7 |
| Week 4 (A) | 8 | 7 |
| Week 6 (A) | 9 | 6 |
| Week 8 (A) | 8 | 7 |
| Week 10 (A) | — | 4 |
| Week 12 (A) | — | 4 |
| Week 0 (B) | 8 | 6 |
| Week 2 (B) | 8 | 7 |
| Week 4 (B) | 6 | 6 |
| Week 6 (B) | 5 | 5 |
| Week 8 (B) | 5 | 6 |
| Week 10 (B) | 3 | — |
| Week 12 (B) | 2 | — |
| Week 0 (C) | 7 | 6 |
| Week 2 (C) | 6 | 6 |
| Week 4 (C) | 5 | — |
| Week 6 (C) | 3 | 4 |
| Week 8 (C) | 3 | 4 |
| Week 10 (C) | 3 | 3 |
| Week 12 (C) | — | 4 |
| Week 0 (D) | 8 | 7 |
| Week 2 (D) | 8 | 7 |
| Week 4 (D) | 8 | 8 |
| Week 6 (D) | 7 | — |
| Week 8 (D) | 7 | — |
| Week 12 (D) | 6 | — |
| Week 0 (E) | 8 | 6 |
| Week 2 (E) | 6 | 6 |
| Week 4 (E) | 4 | — |
| Week 6 (E) | 0 | 6 |
| Week 8 (E) | 8 | 5 |
| Week 10 (E) | — | 5 |
| Week 12 (E) | — | 5 |
| Week 0 (F) | 6 | 7 |
| Week 2 (F) | 5 | — |
| Week 4 (F) | 5 | 7 |
| Week 6 (F) | 5 | 6 |
| Week 8 (F) | 5 | 7 |
| Week 10 (F) | 4 | 4 |
| Week 12 (F) | 5 | — |
| Week 0 (G) | 5 | 6 |
| Week 2 (G) | 3 | 6 |
| Week 4 (G) | 3 | 6 |
| Week 6 (G) | 4 | 7 |
| Week 8 (G) | 5 | 7 |
| Week 10 (G) | 3 | 6 |
| Week 12 (G) | 2 | 5 |
| Week 0 (H) | 8 | 7 |
| Week 2 (H) | 7 | 6 |
| Week 4 (H) | 8 | 5 |
| Week 6 (H) | 7 | 4 |
| Week 8 (H) | 7 | 3 |
| Week 10 (H) | 6 | 2 |
| Week 12 (H) | 7 | 2 |
| Week 0 (I) | — | 6 |
| Week 2 (I) | 5 | 4 |
| Week 4 (I) | 3 | 6 |
| Week 6 (I) | 3 | 4 |
| Week 8 (I) | 2 | 5 |
| Week 10 (I) | 2 | 4 |
| Week 12 (I) | 2 | 3 |
| Week 0 (J) | 8 | 9 |
| Week 2 (J) | 7 | 10 |
| Week 4 (J) | 6 | 8 |
| Week 6 (J) | 7 | — |
| Week 8 (J) | 6 | — |
| Week 12 (J) | 5 | — |
Participants are invited to report any medication changes and submit open-ended comments concerning their use of doxycycline or their acne experiences.
Results for this outcome have not been posted.
Any side effects associated with taking doxycycline for acne is encouraged to be discussed with the clinician
Results for this outcome have not been posted.
Collected over 12 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 100 mg Standard Dose Doxycycline BID | 0/11 (0%) | 0/11 (0%) | 1/11 (9.1%) |
| 20 mg Sub-antimicrobial Dose Doxycycline BID | 0/11 (0%) | 0/11 (0%) | 1/11 (9.1%) |
| Event | 100 mg Standard Dose Doxycycline BID | 20 mg Sub-antimicrobial Dose Doxycycline BID |
|---|---|---|
| Photoallergic reactionSkin and subcutaneous tissue disorders | 1/11 | 0/11 |
| No ImprovementSkin and subcutaneous tissue disorders | 0/11 | 1/11 |
| Age, Categorical(Participants) | 100 mg Standard Dose Doxycycline BID | 20 mg Sub-antimicrobial Dose Doxycycline BID | Total |
|---|---|---|---|
| <=18 years | 11 | 11 | 22 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | 100 mg Standard Dose Doxycycline BID | 20 mg Sub-antimicrobial Dose Doxycycline BID | Total |
|---|---|---|---|
| Female | 7 | 4 | 11 |
| Male | 4 | 7 | 11 |
| Race and Ethnicity Not Collected(Participants) | 100 mg Standard Dose Doxycycline BID | 20 mg Sub-antimicrobial Dose Doxycycline BID | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | 100 mg Standard Dose Doxycycline BID | 20 mg Sub-antimicrobial Dose Doxycycline BID | Total |
|---|---|---|---|
| United States | 11 | 11 | 22 |
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Michigan State University