Trial Outcomes & Findings for Musculoskeletal Effects of Isotretinoin During Acne Treatment in Pediatric Population (NCT NCT00964119)

Results Overview

Bone Marker measurements to assess skeletal toxicities: Change in Bone specific Alkaline Phosphatase: (BSAP) over 5 months of therapy

Recruitment status

TERMINATED

Target enrollment

15 participants

Primary outcome timeframe

Baseline to 5 months post therapy

Results posted on

2015-02-23

Participant Flow

Participant milestones

Participant milestones
Measure	Single Cohort Obervational
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Musculoskeletal Effects of Isotretinoin During Acne Treatment in Pediatric Population

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Cohort Observational n=15 Participants
Age, Categorical <=18 years	14 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 5 months post therapy

Population: Pilot observational study; Principal Investigator left sponsoring institution, data analysis not completed. Data analysis based on interim data (12 subjects). No manuscript published. No final analysis expected. Study has been closed with the local IRB and files archived.

Bone Marker measurements to assess skeletal toxicities: Change in Bone specific Alkaline Phosphatase: (BSAP) over 5 months of therapy

Outcome measures

Outcome measures
Measure	Single Cohort Observational n=12 Participants
Skeletal Toxicities Related to the Use of Isotretinoin Baseline BSAP	62.73 U/L Standard Deviation 35.86
Skeletal Toxicities Related to the Use of Isotretinoin post 5 month isotretinoin therapy	51.80 U/L Standard Deviation 24.26

Adverse Events

Single Cohort Observational

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Single Cohort Observational n=15 participants at risk
Musculoskeletal and connective tissue disorders Arthralgia	53.3% 8/15 • Number of events 8

Additional Information

Dermatology Clinical Trials Administrator

University of Wisconsin - Madison

Phone: 608-287-2640

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place