Clinical trial NCT05399290
Conditions: Acne Vulgaris Pediatrics
Keywords: Acne Vulgaris Doxycycline Sub-Antimicrobial Pediatrics
Sponsor: Michigan State University
Start date: 2020-11-19; Completion date: 2021-11-08
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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.

Detailed description:

Arms: arm 1: Oral, 12 weeks arm 2: Oral, 12 weeks
Interventions: intervention 1: Doxycycline Hyclate
Intervention descriptions: intervention 1: 100 mg vs 20 mg doxycycline hyclate BID for 12 weeks

Protocol documents:
Prot_SAP_ICF_000.pdf: 
A randomized controlled trial investigating the pediatric patient experience 
of subantimicrobial dose doxycycline for acne treatment 
- 
Study protocol 
- 
Statistical analysis plan 
- 
Informed consent form  
 
NCT number: NCT05399290 
Date: October 8, 2022 
 
 


Study Protocol 
 
Inclusion criteria 
Participants are eligible for inclusion in the study if they: are between ages 13 and 17, diagnosed with 
moderate to severe acne, did not have other skin conditions on their face, were not previously treated with 
antibiotics for acne nor received antibiotics for any reason within the last month, did not start a new 
prescription regimen for their acne within the last three months, did not obtain a positive pregnancy test in 
the clinic, and had no cognitive impairments. This minimizes confounding factors in treatment response 
and evaluation of acne (e.g., erythema from other skin conditions). 22 adolescents were identified as 
eligible and, with their parents, consented to participate in the study during the 11/20/2020 through 
09/20/2021 study period. No changes to eligibility were made during the study period.  
 
Randomization and Blinding 
Once consent is obtained, eligible sample adolescents are randomized in a non-blinded, parallel fashion 
and in equal allocation to take either 20 mg or 100 mg doxycycline BID for 12 weeks. Additionally, the 
same over the counter regimen of Adapalene 0.1% gel and Benzoyl Peroxide 2-5% wash was prescribed. 
 
Patients are randomized by choosing a folded piece of paper from a bag that determined their dose. No 
blinding to treatment arms occurred to mimic a real world where patients are informed of their dose. This 
allowed for the determination of patient-perceived effectiveness despite patient awareness of taking a 
lower dose. 
 
Materials and methods 
Participants are emailed a brief Qualtrics survey18 link on the day of enrollment and every two weeks 
thereafter to self-report their doxycycline dose and perceived facial acne severity using the validated 
Patient-Centered Acne Severity Scale19 containing a 10-point visual analog Likert-type scale. Each 
respondent is also invited to report any medication changes and submit open-ended comments concerning 
their use of doxycycline or their acne experiences. Those who submit at least three survey responses will 
be included in the analysis. After 12 weeks of treatment, participants complete a follow-up appointment at 
three months for clinical evaluation. 
 
All participants are to be screened, enrolled, and treated through the Messenger Dermatology Clinic. 
Treatment is initiated at the same visit as enrollment and data collection ends at the three-month 
appointment. Patients picked up their prescription from the pharmacy of their choosing; the clinic and 
study personnel do not dispense the medication themselves. The Qualtrics software is programmed with a 
de-identified study identification number and message encryption. 
 
 
Statistical Analysis Plan 
 
Data analysis will be performed with S.P.S.S. Version 28 analytic software using Friedman repeated 
measures test and Chi square test. For all analytic procedures, a two-tailed coefficient α < 0.05 will be 
observed to indicate statistical significance. 
 
 
 


 
Research Participant Information and Consent Form 
 
You are being asked to participate in a research study and your parent is being asked to 
provide parental permission. Researchers are required to provide an assent 
form/parental permission form to inform both of you about the research study, to convey 
that participation is voluntary, to explain risks and benefits of participation, and to 
empower you to make an informed decision. You should feel free to ask the researchers 
any questions you may have.   Both of you need to agree for the child’s participation in 
this study.    
 
Study Title: Effectiveness of Sub-Antimicrobial dose of doxycycline in the treatment of 
acne 
Researcher and Title: Dr. Gallagher  
Department and Institution: Michigan State University College of Human Medicine 
Address and Contact Information: 
Messenger Dermatology, 1515 Lake Lansing Road, 
Lansing, MI 48912 
517-487-0128 
 
1.  PURPOSE OF RESEARCH                                       
 
● You/your child are being asked to participate in a research study of whether a lower 
dose of the antibiotic doxycycline is still effective in treating acne. 
● You/your child have been selected as a possible participant in this study because we 
would normally treat this type of acne with doxycycline. 
● From this study, the researchers hope to learn whether this lower dose is effective in 
treating acne. 
● You/your child’s participation in this study will take about three months, and possibly 
up to six months. 


● An alternative to participating in this study is to receive the standard dosing regimen 
of doxycycline, which is 100mg twice a day. 
 
 
 
 
 
 
2. WHAT YOU WILL DO  
 
● As part of this study, you/your child will be asked to fill out the initial screening 
document and consent forms. During screening, female participants of reproductive 
age will be required to take a pregnancy test, as part of standard drug safety 
processes. The Messenger clinic will cover the cost of this pregnancy test. 
● You/your child will be asked to take your prescription as directed. As part of this 
study, you/your child will be randomly assigned to take either 20mg of doxycycline 
twice a day or 100mg  of doxycycline twice a day. 
● You/your child will also be asked to fill out a brief online questionnaire at home every 
two weeks, in order to evaluate whether or not you feel there any improvements in 
your acne. 
● Lastly, it is important that you/your child come back for a follow-up appointment after 
about three months of treatment for clinical evaluation.  
 
 
3. POTENTIAL BENEFITS      
                                                   
• You/your child’s participation in this study may help us understand how to best treat 
acne while decreasing antibiotic resistance.  Antibiotic resistance is when bacteria 
are not as easily treated by antibiotics.  Widespread use of standard dose antibiotics 
can make bacteria resistant and lead to infections that are more difficult to treat in 


the future. The lower dose of doxycycline in this study is too low to affect bacteria, 
but still has anti-inflammatory action. 
 
 
4. POTENTIAL RISKS   
                                                                 
● It is possible that you/your child may have an adverse reaction to the antibiotic 
doxycycline. Common adverse reactions to include nausea, vomiting, diarrhea, and 
a rash in response to sunlight exposure. 
● It is also possible that this lower dose of doxycycline may not be as effective in 
treating acne as the standard dose, and that you/your child’s acne may not improve 
while participating in this study. 
● Doxycycline is contraindicated in pregnancy. If you/your child become pregnant 
during the study, the drug needs to be stopped immediately due to the risk to the 
fetus and you/your child will be withdrawn from the study. We encourage females of 
reproductive age who may become pregnant to take proper precautions to prevent 
pregnancy. 
● Like any medication, doxycycline carries its own risks, described on the package 
insert. These risks would be present regardless of participation in the study. One 
such rare risk, as with all antibiotics, is inadvertently causing antibiotic resistance. 
 
 
 
5.  PRIVACY AND CONFIDENTIALITY                         
 
● As a participant in this study, you/your child’s privacy and confidentiality will be 
rigorously protected. 
● The data for this project will be kept confidential. You/your child will never be 
identified in any reporting of the data. 
● Information about you/your child will be kept confidential to the maximum extent 
allowable by law. 


● The patient surveys are anonymous surveys through Qualtrics, a secure survey 
system, with no identifiable data tracking to the submission. 
● Once collected, data will be deidentified and stored on a password-protected, secure 
server until completion of the study. A correlation tool will be used to de-identify data 
that will be kept separately in password protected files. 
● Information that personally identifies you/your child may be removed from the data, 
so that it may then be used for future research studies. After this de-identification it 
may be used for future research or distributed to another investigator for future 
studies without additional informed consent from you/your child. 
● Clinically relevant research results will not be returned to you/your child unless 
you/your child request it. 
● The research staff and MSU HRPP are the main entities who will have access to the 
data for the duration of the study, and for the three years following the completion of 
the study. The HRPP oversees research studies to ensure patient safety. It is 
possible that the Food and Drug Administration may inspect the records. 
 
 
6. YOUR RIGHTS TO PARTICIPATE, SAY NO, OR WITHDRAW    
● Participation is voluntary. Refusal to participate will involve no penalty or loss of 
benefits to which you/your child are otherwise entitled. You may discontinue 
participation at any time without penalty or loss of benefits to which you are otherwise 
entitled. 
● You/your child have the right to say no. 
● You/your child may change your mind at any time and withdraw.  
● You/your child may choose not to answer specific questions or to stop participating at 
any time.  
● Choosing not to participate or withdrawing from this study will not make any difference 
in the quality of any services you may receive. 
● You/your child will be told of any significant findings that develop during the course of 
the study that may influence your willingness to continue to participate in the research. 
 


7.  COSTS AND COMPENSATION FOR BEING IN THE STUDY   
● There will be no additional cost to you/your child for participating in this study. You 
will be responsible for the normal costs involved in treatment (such as prescription 
co-pay, etc), but there is no additional cost due to participating in the study. 
● You/your child will not receive money or any other form of compensation for 
participating in this study.   
 
8. INJURY CLAUSE 
● If you are injured as a result of your participation in this research project, Michigan 
State University will assist you in obtaining emergency care, if necessary, for your 
research related injuries. If you have insurance for medical care, your insurance 
carrier will be billed in the ordinary manner. As with any medical insurance, any 
costs that are not covered or are in excess of what are paid by your insurance, 
including deductibles, will be your responsibility. The University’s policy is not to 
provide financial compensation for lost wages, disability, pain or discomfort, unless 
required by law to do so. This does not mean that you are giving up any legal rights 
you may have. You may contact Dr. Gallagher with any questions or to report an 
injury. 
 
9.  CONTACT INFORMATION                                                  
If you have concerns or questions about this study, such as scientific issues, how to do 
any part of it, or to report an injury, please contact the researcher: 
Dr. Michelle Gallagher 
Messenger Dermatology 
1515 Lake Lansing Road, Lansing, MI 48912 
Phone: 517-487-0128 
 
If you have questions or concerns about your role and rights as a research participant, 
would like to obtain information or offer input, or would like to register a complaint about 
this study, you may contact, anonymously if you wish, the Michigan State University’s 


Human Research Protection Program at 517-355-2180, Fax 517-432-4503, or e-mail 
irb@msu.edu or regular mail at 4000 Collins Rd, Suite 136, Lansing, MI 48910. 
 
10.  DOCUMENTATION OF INFORMED CONSENT. 
 
Your signatures below means that you voluntarily give your permission for your child to 
participate in this research study and that your child has given his/her assent to participate. 
 
 
________________________________________ 
 
 
_____________________________ 
Signature 
 
 
 
 
 
 
 
Date 
 
________________________________________ 
 
 
_____________________________ 
Signature of Assenting Child (13-17) 
 
 
Date 
 
You will be given a copy of this form to keep.