Trial Outcomes & Findings for Trial of Topical Cidofovir for the Prevention of Hair Growth (NCT NCT00948506)
NCT ID: NCT00948506
Last Updated: 2012-03-19
Results Overview
Number of participants with a score of 2 or less on the Physician Global Assessment (PGA) of Hair Density at the end of active treatment. The five point scale ranges from 0 (total alopecia) to 5 (very dense).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
up to 8 weeks or end of active treatment
Results posted on
2012-03-19
Participant Flow
Participant milestones
| Measure |
1% Cidofovir and Placebo
Subjects received 1% topical cidofovir to one side of the face and placebo to the other side of the face in a split-face design.
|
3% Cidofovir and Placebo
Subjects received 3% topical cidofovir to one side of the face and placebo to the other side of the face in a split-face design.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
9
|
|
Overall Study
COMPLETED
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
1% Cidofovir and Placebo
Subjects received 1% topical cidofovir to one side of the face and placebo to the other side of the face in a split-face design.
|
3% Cidofovir and Placebo
Subjects received 3% topical cidofovir to one side of the face and placebo to the other side of the face in a split-face design.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
Baseline Characteristics
Trial of Topical Cidofovir for the Prevention of Hair Growth
Baseline characteristics by cohort
| Measure |
1% Cidofovir and Placebo
n=11 Participants
Subjects received 1% topical cidofovir to one side of the face and placebo to the other side of the face in a split-face design.
|
3% Cidofovir and Placebo
n=9 Participants
Subjects received 3% topical cidofovir to one side of the face and placebo to the other side of the face in a split-face design.
|
Total
n=20 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
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 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
|
36.55 years
STANDARD_DEVIATION 8.32 • n=5 Participants
|
31.44 years
STANDARD_DEVIATION 12.02 • n=7 Participants
|
34.25 years
STANDARD_DEVIATION 10.20 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
9 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 8 weeks or end of active treatmentPopulation: The analysis was performed using intention-to-treat and all enrolled participants who received treatment were included in the analysis. For participants who withdrew during treatment, the data from their last visit were carried forward.
Number of participants with a score of 2 or less on the Physician Global Assessment (PGA) of Hair Density at the end of active treatment. The five point scale ranges from 0 (total alopecia) to 5 (very dense).
Outcome measures
| Measure |
1% Cidofovir
n=11 Participants
Subjects received 1% topical cidofovir to one side of the face in a split-face design (placebo was applied to the other side of the face).
|
3% Cidofovir
n=9 Participants
Subjects received 3% topical cidofovir to one side of the face in a split-face design (placebo was applied to the other side of the face).
|
Placebo
n=20 Participants
Subjects received placebo to one side of the face in a split-face design (1% or 3% cidofovir was applied to the other side of the face).
|
|---|---|---|---|
|
Physician's Global Assessment (PGA) of Hair Density
|
1 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: up to 16 weeksPopulation: The analysis was performed using intention-to-treat, whereby all enrolled participants who received treatment were analyzed.
Number of participants who reported an adverse event (as assessed by subject interview and if indicated, physical exam) or had abnormal finding on urine and blood laboratory examination
Outcome measures
| Measure |
1% Cidofovir
n=11 Participants
Subjects received 1% topical cidofovir to one side of the face in a split-face design (placebo was applied to the other side of the face).
|
3% Cidofovir
n=9 Participants
Subjects received 3% topical cidofovir to one side of the face in a split-face design (placebo was applied to the other side of the face).
|
Placebo
Subjects received placebo to one side of the face in a split-face design (1% or 3% cidofovir was applied to the other side of the face).
|
|---|---|---|---|
|
Subject-reported Adverse Events or Abnormal Findings
|
6 participants
|
6 participants
|
—
|
Adverse Events
1% Cidofovir and Placebo
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
3% Cidofovir and Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1% Cidofovir and Placebo
n=11 participants at risk
Subjects received 1% topical cidofovir to one side of the face and placebo to the other side of the face in a split-face design.
|
3% Cidofovir and Placebo
n=9 participants at risk
Subjects received 3% topical cidofovir to one side of the face and placebo to the other side of the face in a split-face design.
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal bleeding
|
9.1%
1/11 • Number of events 1
|
0.00%
0/9
|
Other adverse events
| Measure |
1% Cidofovir and Placebo
n=11 participants at risk
Subjects received 1% topical cidofovir to one side of the face and placebo to the other side of the face in a split-face design.
|
3% Cidofovir and Placebo
n=9 participants at risk
Subjects received 3% topical cidofovir to one side of the face and placebo to the other side of the face in a split-face design.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
27.3%
3/11 • Number of events 3
|
11.1%
1/9 • Number of events 1
|
|
Nervous system disorders
Headache
|
18.2%
2/11 • Number of events 2
|
11.1%
1/9 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema of the treatment area
|
18.2%
2/11 • Number of events 2
|
11.1%
1/9 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritis of treatment area
|
9.1%
1/11 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
|
Infections and infestations
Cold sores
|
9.1%
1/11 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash over the untreated area
|
0.00%
0/11
|
11.1%
1/9 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin tenderness of untreated area
|
0.00%
0/11
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/11
|
11.1%
1/9 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/11
|
11.1%
1/9 • Number of events 1
|
|
Nervous system disorders
Eyelid twitch
|
0.00%
0/11
|
11.1%
1/9 • Number of events 1
|
|
Nervous system disorders
Flare of pre-existing brachial neuritis
|
0.00%
0/11
|
11.1%
1/9 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dog bite
|
0.00%
0/11
|
11.1%
1/9 • Number of events 1
|
|
Surgical and medical procedures
Toothache after a dental procedures
|
9.1%
1/11 • Number of events 1
|
0.00%
0/9
|
|
Surgical and medical procedures
Neck swelling after surgical nerve block
|
9.1%
1/11 • Number of events 1
|
0.00%
0/9
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place