Subantimicrobial Doxycycline in Acne | NCT05399290

Subantimicrobial Doxycycline in Acne | NCT05399290 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
100 mg standard dose doxycycline BID	Active Comparator	Oral, 12 weeks	Drug: Doxycycline Hyclate
20 mg sub-antimicrobial dose doxycycline BID	Experimental	Oral, 12 weeks	Drug: Doxycycline Hyclate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Doxycycline Hyclate	Drug	100 mg vs 20 mg doxycycline hyclate BID for 12 weeks	100 mg standard dose doxycycline BID 20 mg sub-antimicrobial dose doxycycline BID

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	12 weeks

Other Outcomes

Measure	Description	Time Frame
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.	12 weeks
Side Effects

Contacts/Locations Module

Name	Affiliation	Role
Michelle Gallagher, DO	Michigan State University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Messenger Dermatology Clinic		Lansing	Michigan	48912	United States

Arm/Group Information

ID	Title	Description
FG000	100 mg Standard Dose Doxycycline BID	Oral, 12 weeks Doxycycline Hyclate: 100 mg vs 20 mg doxycycline hyclate BID for 12 weeks
FG001	20 mg Sub-antimicrobial Dose Doxycycline BID	Oral, 12 weeks Doxycycline Hyclate: 100 mg vs 20 mg doxycycline hyclate BID for 12 weeks

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG00011 subjects FG00111 subjects
COMPLETED		FG00010 subjects FG00110 subjects
NOT COMPLETED		FG0001 subjects FG0011 subjects

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	100 mg Standard Dose Doxycycline BID	Oral, 12 weeks Doxycycline Hyclate: 100 mg vs 20 mg doxycycline hyclate BID for 12 weeks
BG001	20 mg Sub-antimicrobial Dose Doxycycline BID

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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

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.

Posted

Number

score on a scale

12 weeks

Survey Ratings

ID	Title	Description

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	100 mg Standard Dose Doxycycline BID	Oral, 12 weeks Doxycycline Hyclate: 100 mg vs 20 mg doxycycline hyclate BID for 12 weeks

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Photoallergic reaction	Skin and subcutaneous tissue disorders		Non-systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Erika Malana	Michigan State University	5173038716		malanaer@msu.edu

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP_ICF	Yes	Yes	Yes	Study Protocol, Statistical Analysis Plan, and Informed Consent Form	Oct 8, 2022	Oct 8, 2022	Prot_SAP_ICF_000.pdf

Condition Browse Module

ID	Term
D000152	Acne Vulgaris

ID	Term
D017486	Acneiform Eruptions
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D012625	Sebaceous Gland Diseases

Intervention Browse Module

ID	Term
D004318	Doxycycline

ID	Term
D013754	Tetracyclines
D009279	Naphthacenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic

Title

Denominators

Categories

Week 0 (A)

- ParticipantsOG0001
- ParticipantsOG0011
- Survey RatingsOG0001
- Survey RatingsOG0011

Title	Measurements
	OG0008 OG0018

Week 2 (A)

- ParticipantsOG0001
- ParticipantsOG0011
- Survey RatingsOG0001
- Survey RatingsOG001

Week 4 (A)

- ParticipantsOG0001
- ParticipantsOG0011
- Survey RatingsOG0001
- Survey RatingsOG001

Week 6 (A)

- ParticipantsOG0001
- ParticipantsOG0011
- Survey RatingsOG0001
- Survey RatingsOG001

Week 8 (A)

- ParticipantsOG0001
- ParticipantsOG0011
- Survey RatingsOG0001
- Survey RatingsOG001

Week 10 (A)

- ParticipantsOG0000
- ParticipantsOG0011
- Survey RatingsOG0000
- Survey RatingsOG001

Week 12 (A)

- ParticipantsOG0000
- ParticipantsOG0011
- Survey RatingsOG0000
- Survey RatingsOG001

Week 0 (B)

- ParticipantsOG0001
- ParticipantsOG0011
- Survey RatingsOG0001
- Survey RatingsOG001

Week 2 (B)

- ParticipantsOG0001
- ParticipantsOG0011
- Survey RatingsOG0001
- Survey RatingsOG001

Week 4 (B)

- ParticipantsOG0001
- ParticipantsOG0011
- Survey RatingsOG0001
- Survey RatingsOG001

Week 6 (B)

- ParticipantsOG0001
- ParticipantsOG0011
- Survey RatingsOG0001
- Survey RatingsOG001

Week 8 (B)

- ParticipantsOG0001
- ParticipantsOG0011
- Survey RatingsOG0001
- Survey RatingsOG001

Week 10 (B)

- ParticipantsOG0001
- ParticipantsOG0010
- Survey RatingsOG0001
- Survey RatingsOG001

Week 12 (B)

- ParticipantsOG0001
- ParticipantsOG0010
- Survey RatingsOG0001
- Survey RatingsOG001

Week 0 (C)

- ParticipantsOG0001
- ParticipantsOG0011
- Survey RatingsOG0001
- Survey RatingsOG001

Week 2 (C)

- ParticipantsOG0001
- ParticipantsOG0011
- Survey RatingsOG0001
- Survey RatingsOG001

Week 4 (C)

- ParticipantsOG0001
- ParticipantsOG0010
- Survey RatingsOG0001
- Survey RatingsOG001

Week 6 (C)

- ParticipantsOG0001
- ParticipantsOG0011
- Survey RatingsOG0001
- Survey RatingsOG001

Week 8 (C)

- ParticipantsOG0001
- ParticipantsOG0011
- Survey RatingsOG0001
- Survey RatingsOG001

Week 10 (C)

- ParticipantsOG0001
- ParticipantsOG0011
- Survey RatingsOG0001
- Survey RatingsOG001

Week 12 (C)

- ParticipantsOG0000
- ParticipantsOG0011
- Survey RatingsOG0000
- Survey RatingsOG001

Week 0 (D)

- ParticipantsOG0001
- ParticipantsOG0011
- Survey RatingsOG0001
- Survey RatingsOG001

Week 2 (D)

- ParticipantsOG0001
- ParticipantsOG0011
- Survey RatingsOG0001
- Survey RatingsOG001

Week 4 (D)

- ParticipantsOG0001
- ParticipantsOG0011
- Survey RatingsOG0001
- Survey RatingsOG001

Week 6 (D)

- ParticipantsOG0001
- ParticipantsOG0010
- Survey RatingsOG0001
- Survey RatingsOG001

Week 8 (D)

- ParticipantsOG0001
- ParticipantsOG0010
- Survey RatingsOG0001
- Survey RatingsOG001

Week 10 (D)

- ParticipantsOG0000
- ParticipantsOG0010
- Survey RatingsOG0000
- Survey RatingsOG001

Week 12 (D)

- ParticipantsOG0001
- ParticipantsOG0010
- Survey RatingsOG0001
- Survey RatingsOG001

Week 0 (E)

- ParticipantsOG0001
- ParticipantsOG0011
- Survey RatingsOG0001
- Survey RatingsOG001

Week 2 (E)

- ParticipantsOG0001
- ParticipantsOG0011
- Survey RatingsOG0001
- Survey RatingsOG001

Week 4 (E)

- ParticipantsOG0001
- ParticipantsOG0010
- Survey RatingsOG0001
- Survey RatingsOG001

Week 6 (E)

- ParticipantsOG0001
- ParticipantsOG0011
- Survey RatingsOG0001
- Survey RatingsOG001

Week 8 (E)

- ParticipantsOG0001
- ParticipantsOG0011
- Survey RatingsOG0001
- Survey RatingsOG001

Week 10 (E)

- ParticipantsOG0000
- ParticipantsOG0011
- Survey RatingsOG0000
- Survey RatingsOG001

Week 12 (E)

- ParticipantsOG0000
- ParticipantsOG0011
- Survey RatingsOG0000
- Survey RatingsOG001

Week 0 (F)

- ParticipantsOG0001
- ParticipantsOG0011
- Survey RatingsOG0001
- Survey RatingsOG001

Week 2 (F)

- ParticipantsOG0001
- ParticipantsOG0010
- Survey RatingsOG0001
- Survey RatingsOG001

Week 4 (F)

- ParticipantsOG0001
- ParticipantsOG0011
- Survey RatingsOG0001
- Survey RatingsOG001

Week 6 (F)

- ParticipantsOG0001
- ParticipantsOG0011
- Survey RatingsOG0001
- Survey RatingsOG001

Week 8 (F)

- ParticipantsOG0001
- ParticipantsOG0011
- Survey RatingsOG0001
- Survey RatingsOG001

Week 10 (F)

- ParticipantsOG0001
- ParticipantsOG0011
- Survey RatingsOG0001
- Survey RatingsOG001

Week 12 (F)

- ParticipantsOG0001
- ParticipantsOG0010
- Survey RatingsOG0001
- Survey RatingsOG001

Week 0 (G)

- ParticipantsOG0001
- ParticipantsOG0011
- Survey RatingsOG0001
- Survey RatingsOG001

Week 2 (G)

- ParticipantsOG0001
- ParticipantsOG0011
- Survey RatingsOG0001
- Survey RatingsOG001

Week 4 (G)

- ParticipantsOG0001
- ParticipantsOG0011
- Survey RatingsOG0001
- Survey RatingsOG001

Week 6 (G)

- ParticipantsOG0001
- ParticipantsOG0011
- Survey RatingsOG0001
- Survey RatingsOG001

Week 8 (G)

- ParticipantsOG0001
- ParticipantsOG0011
- Survey RatingsOG0001
- Survey RatingsOG001

Week 10 (G)

- ParticipantsOG0001
- ParticipantsOG0011
- Survey RatingsOG0001
- Survey RatingsOG001

Week 12 (G)

- ParticipantsOG0001
- ParticipantsOG0011
- Survey RatingsOG0001
- Survey RatingsOG001

Week 0 (H)

- ParticipantsOG0001
- ParticipantsOG0011
- Survey RatingsOG0001
- Survey RatingsOG001

Week 2 (H)

- ParticipantsOG0001
- ParticipantsOG0011
- Survey RatingsOG0001
- Survey RatingsOG001

Week 4 (H)

- ParticipantsOG0001
- ParticipantsOG0011
- Survey RatingsOG0001
- Survey RatingsOG001

Week 6 (H)

- ParticipantsOG0001
- ParticipantsOG0011
- Survey RatingsOG0001
- Survey RatingsOG001

Week 8 (H)

- ParticipantsOG0001
- ParticipantsOG0011
- Survey RatingsOG0001
- Survey RatingsOG001

Week 10 (H)

- ParticipantsOG0001
- ParticipantsOG0011
- Survey RatingsOG0001
- Survey RatingsOG001

Week 12 (H)

- ParticipantsOG0001
- ParticipantsOG0011
- Survey RatingsOG0001
- Survey RatingsOG001

Week 0 (I)

- ParticipantsOG0000
- ParticipantsOG0011
- Survey RatingsOG0000
- Survey RatingsOG001

Week 2 (I)

- ParticipantsOG0001
- ParticipantsOG0011
- Survey RatingsOG0001
- Survey RatingsOG001

Week 4 (I)

- ParticipantsOG0001
- ParticipantsOG0011
- Survey RatingsOG0001
- Survey RatingsOG001

Week 6 (I)

- ParticipantsOG0001
- ParticipantsOG0011
- Survey RatingsOG0001
- Survey RatingsOG001

Week 8 (I)

- ParticipantsOG0001
- ParticipantsOG0011
- Survey RatingsOG0001
- Survey RatingsOG001

Week 10 (I)

- ParticipantsOG0001
- ParticipantsOG0011
- Survey RatingsOG0001
- Survey RatingsOG001

Week 12 (I)

- ParticipantsOG0001
- ParticipantsOG0011
- Survey RatingsOG0001
- Survey RatingsOG001

Week 0 (J)

- ParticipantsOG0001
- ParticipantsOG0011
- Survey RatingsOG0001
- Survey RatingsOG001

Week 2 (J)

- ParticipantsOG0001
- ParticipantsOG0011
- Survey RatingsOG0001
- Survey RatingsOG001

Week 4 (J)

- ParticipantsOG0001
- ParticipantsOG0011
- Survey RatingsOG0001
- Survey RatingsOG001

Week 6 (J)

- ParticipantsOG0001
- ParticipantsOG0010
- Survey RatingsOG0001
- Survey RatingsOG001

Week 8 (J)

- ParticipantsOG0001
- ParticipantsOG0010
- Survey RatingsOG0001
- Survey RatingsOG001

Week 10 (J)

- ParticipantsOG0000
- ParticipantsOG0010
- Survey RatingsOG0000
- Survey RatingsOG001

Week 12 (J)

- ParticipantsOG0001
- ParticipantsOG0010
- Survey RatingsOG0001
- Survey RatingsOG001

Group IDs	Statistical Method	P-Value	Non-Inferiority Type	Non-Inferiority Comment
OG000 OG001	Chi-squared	0.677	Other	Chi square analysis was conducted to detect any significant between group differences (100 mg vs 20 mg) in perceived acne severity.
OG000	Friedman's test	0.002	Other	Friedman's test was conducted for the 100 mg treatment arm to detect any significant within group differences in perceived acne severity.
OG001	Fried	0.018	Other	Friedman's test was conducted for the 20 mg treatment arm to detect any significant within group differences in perceived acne severity.