Trial Outcomes & Findings for A Study to Examine the Safety and Efficacy of Drospirenone and Ethinyl Estradiol (YAZ) Versus Placebo In HS (NCT NCT00722800)

Results Overview

The Sartorius Severity score reflects changes in hidradenitis suppurative symptoms, namely the number of lesions (abscesses, nodules, and fistulas) and the longest distance between lesions. A total score is derived based on assessments at up to 8 distinct anatomical regions and ranges from 5 to indefinite. Smaller numbers are better scores and indicate less lesion involvement, thus decreases (negative changes) from baseline indicate improvement in severity of disease.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

6 months

Results posted on

2014-02-10

Participant Flow

Recruitment methods used were Craig's list, Metro and our hospitals email. All subjects were seen at MGH.

One subject was ineligible because she was taking ibuprofen regularly.

Participant milestones

Participant milestones
Measure	Drospirenone and Ethinyl Estradiol (YAZ) drospirenone and ethinyl estradiol (YAZ) once a day for 6 months	Placebo Tablets Placebo tablet once a day for 6 months
Overall Study STARTED	2	2
Overall Study COMPLETED	0	2
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Drospirenone and Ethinyl Estradiol (YAZ) drospirenone and ethinyl estradiol (YAZ) once a day for 6 months	Placebo Tablets Placebo tablet once a day for 6 months
Overall Study Withdrawal by Subject	1	0
Overall Study Physician Decision	1	0

Baseline Characteristics

A Study to Examine the Safety and Efficacy of Drospirenone and Ethinyl Estradiol (YAZ) Versus Placebo In HS

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Drospirenone and Ethinyl Estradiol (YAZ) n=2 Participants drospirenone and ethinyl estradiol (YAZ) once a day for 6 months	Placebo Tablets n=2 Participants Placebo tablet once a day for 6 months	Total n=4 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	34 years STANDARD_DEVIATION 12.73 • n=5 Participants	35.5 years STANDARD_DEVIATION 14.85 • n=7 Participants	34.75 years STANDARD_DEVIATION 11.33 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

The Sartorius Severity score reflects changes in hidradenitis suppurative symptoms, namely the number of lesions (abscesses, nodules, and fistulas) and the longest distance between lesions. A total score is derived based on assessments at up to 8 distinct anatomical regions and ranges from 5 to indefinite. Smaller numbers are better scores and indicate less lesion involvement, thus decreases (negative changes) from baseline indicate improvement in severity of disease.

Outcome measures

Outcome measures
Measure	Drospirenone and Ethinyl Estradiol (YAZ) n=2 Participants drospirenone and ethinyl estradiol (YAZ) once a day for 6 months	Placebo Tablets n=2 Participants Placebo tablet once a day for 6 months
Mean Improvement in the Sartorius Severity Score at Month 6.	-3.5 units on a scale Standard Deviation 2.1213	12 units on a scale Standard Deviation 33.9411

SECONDARY outcome

Timeframe: 6 months from Baseline

For this pain assessment, the participant indicated the level of average pain experienced over the past 24 hours on a horizontal line, 10 cm in length. A score of 0 indicated "no pain" and a score of 10 indicated "worst pain". The value indicates the change from the baseline participant assessment on the 0 to 10 scale. A negative value indicates a reduction in pain intensity.

Outcome measures

Outcome measures
Measure	Drospirenone and Ethinyl Estradiol (YAZ) n=2 Participants drospirenone and ethinyl estradiol (YAZ) once a day for 6 months	Placebo Tablets n=2 Participants Placebo tablet once a day for 6 months
Change From Baseline in VAS Pain Scale at Month 6.	-2.25 units on a scale Standard Deviation 1.06066	2 units on a scale Standard Deviation 8.485281

SECONDARY outcome

Timeframe: 6 months

Dermatology Life Quality Index (DLQI) Score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. The DLQI score ranges from 0 (best) to 30 (worst).

Outcome measures

Outcome measures
Measure	Drospirenone and Ethinyl Estradiol (YAZ) n=2 Participants drospirenone and ethinyl estradiol (YAZ) once a day for 6 months	Placebo Tablets n=2 Participants Placebo tablet once a day for 6 months
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 6.	3 points Standard Deviation 1.4142	8.5 points Standard Deviation 19.0919

Adverse Events

Drospirenone and Ethinyl Estradiol (YAZ)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo Tablets

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Drospirenone and Ethinyl Estradiol (YAZ) n=2 participants at risk drospirenone and ethinyl estradiol (YAZ) once a day for 6 months	Placebo Tablets n=2 participants at risk Placebo tablet once a day for 6 months
Gastrointestinal disorders Nausea	0.00% 0/2 • 6 months	50.0% 1/2 • Number of events 1 • 6 months
Respiratory, thoracic and mediastinal disorders Upper respiratory infection	0.00% 0/2 • 6 months	50.0% 1/2 • Number of events 1 • 6 months
Skin and subcutaneous tissue disorders fistula with bacterial infection R-axilla	50.0% 1/2 • Number of events 1 • 6 months	0.00% 0/2 • 6 months

Additional Information

Alexandra B. Kimball, MD

MGH

Phone: 617-726-5066

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place