Trial Outcomes & Findings for Weekly Isotretinoin Therapy Study (NCT NCT04594759)

Results Overview

Will look at clinical photos before, during, and after treatment and grade acne using a validated, clinical grading system (Comprehensive Acne Severity Scale, CASS) with "0" being clear skin and "5" being very severe acne. Participants are eligible for the study if their score is 3 or higher. An improvement in their visible acne is a score of 2, 1, or 0 at the end of the 4 months of treatment.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

22 participants

Primary outcome timeframe

Baseline and end of treatment, approximately 4 months

Results posted on

2022-05-09

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Group Isotretinoin: Participants will be getting isotretinoin (1-1.5 mg/kg/week)
Overall Study STARTED	22
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment Group Isotretinoin: Participants will be getting isotretinoin (1-1.5 mg/kg/week)
Overall Study Lost to Follow-up	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Group n=22 Participants Isotretinoin: Participants will be getting isotretinoin (1-1.5 mg/kg/week)
Age, Continuous	24.77 years STANDARD_DEVIATION 8.74 • n=22 Participants
Sex: Female, Male Female	13 Participants n=22 Participants
Sex: Female, Male Male	9 Participants n=22 Participants
Region of Enrollment United States	22 Participants n=22 Participants

PRIMARY outcome

Timeframe: Baseline and end of treatment, approximately 4 months

Population: The amount of participants that were analyzed is less than the original number enrolled. There were 3 participants that did not complete the study and were not analyzed at the end of the 4 months of treatment.

Will look at clinical photos before, during, and after treatment and grade acne using a validated, clinical grading system (Comprehensive Acne Severity Scale, CASS) with "0" being clear skin and "5" being very severe acne. Participants are eligible for the study if their score is 3 or higher. An improvement in their visible acne is a score of 2, 1, or 0 at the end of the 4 months of treatment.

Outcome measures

Outcome measures
Measure	Treatment Group n=19 Participants Isotretinoin: Participants will be getting isotretinoin (1-1.5 mg/kg/week)
Number of Participants That Showed Improvement in Their Visible Acne (Efficacy of Once Weekly Isotretinoin)	18 Participants

SECONDARY outcome

Timeframe: Baseline, monthly, and end of treatment, total of 4 months

Population: Three subjects did not complete the study for analysis.

Participants will use the Dermatology Life Quality Index survey which measures how much their skin problems affect their life. 10 questions are asked with answers "Very much," " A lot," "A little," "Not at all," or "Not relevant". The answers correlate to a number ("Very much" =3, " A lot" = 2, "A little"=1, "Not at all"= 0, "Not relevant"=0) and the answered are added together to get a score for that month. The higher the score the more their skin impacts their day to day activities. An improvement in their quality of life is a lower score at 4 months compared to baseline score.

Outcome measures

Outcome measures
Measure	Treatment Group n=19 Participants Isotretinoin: Participants will be getting isotretinoin (1-1.5 mg/kg/week)
Number of Participants With a Change in Quality of Life	17 Participants

SECONDARY outcome

Timeframe: through study completion, an average of 4 months

Population: 3 participants were lost to follow up and did not complete the final adverse event questionnaire. One participant can have more than one event.

Participants will fill out a survey regarding nonserious and serious adverse events.

Outcome measures

Outcome measures
Measure	Treatment Group n=19 Participants Isotretinoin: Participants will be getting isotretinoin (1-1.5 mg/kg/week)
Number of Side Effects Reported at the End of 4 Months	24 events

Adverse Events

Treatment Group

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment Group n=19 participants at risk Isotretinoin: Participants will be getting isotretinoin (1-1.5 mg/kg/week)
Skin and subcutaneous tissue disorders Dry lips/eyes	52.6% 10/19 • Through study completion, an average of 4 months. Participants could have more than one adverse event.
Skin and subcutaneous tissue disorders Dry skin	57.9% 11/19 • Through study completion, an average of 4 months. Participants could have more than one adverse event.
Musculoskeletal and connective tissue disorders Mild myalgias	57.9% 11/19 • Through study completion, an average of 4 months. Participants could have more than one adverse event.

Additional Information

Dr. Samantha Karlin

Medical University of South Carolina

Phone: (843)- 714-0146

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place