Trial Outcomes & Findings for Molecular Effects of Topical Calcipotriene on Morphea (NCT NCT02411643)

NCT ID: NCT02411643

Last Updated: 2018-09-13

Results Overview

Skin biopsy will be taken at day 0 and 3 months, RNA will be looked at for different gene expression levels

• Recruitment status: TERMINATED
• Study phase: EARLY_PHASE1
• Target enrollment: 2 participants
• Primary outcome timeframe: day 0 and 3 months
• Results posted on: 2018-09-13

Participant Flow

Participant milestones

Measure	Topical Calcipotriene 0.005% Ointment Calcipotriene 0.005% applied to affected areas twice daily to all enrolled subjects topical calcipotriene 0.005% ointment: Affected area will be treated twice daily for 3 months
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Molecular Effects of Topical Calcipotriene on Morphea

Baseline characteristics by cohort

Measure	Topical Calcipotriene 0.005% Ointment n=2 Participants Calcipotriene 0.005% applied to affected areas twice daily to all enrolled subjects topical calcipotriene 0.005% ointment: Affected area will be treated twice daily for 3 months
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

PRIMARY outcome

Timeframe: day 0 and 3 months

Population: Study was terminated prior to obtaining results.

Skin biopsy will be taken at day 0 and 3 months, RNA will be looked at for different gene expression levels

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: day 0 and 3 months

Population: Study was terminated prior to obtaining results.

Quality of life questions will be asked at day 0 and 3 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: day 0 and 3 months

Population: Study was terminated before results were obtained.

The firmness or tightness of the skin will be measured throughout the body at day 0 and 3 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: day 0 and 3 months

Population: Study was terminated before results were obtained.

Skin biopsy will be taken at baseline and 3 months, skin will be examined for expression levels of different proteins

Outcome measures

Outcome data not reported

Adverse Events

Topical Calcipotriene 0.005% Ointment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Stephanie Rangel

Northwestern University

Phone: 3125035942

Email: stephanie.rangel@northwestern.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place