Trial Outcomes & Findings for Safety Study of a Sensitive Sensual Touch and Personal Lubricant (NCT NCT01271036)
NCT ID: NCT01271036
Last Updated: 2014-03-04
Results Overview
Severity of physical irritation scored by the Investigator on a scale from 0 (no irritation) to 6 (presence of lesions). Since a score of 0 is required at baseline for inclusion in the study, this any score represents a change from baseline and the trial is considered baseline-controlled. The number of participants with physical irritation scores after one week was recorded (along with categorical severity).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
124 participants
Primary outcome timeframe
One week
Results posted on
2014-03-04
Participant Flow
Only one IP was used per couple in this single-arm study. At baseline (visit 1), all qualified subjects received the IP for use per protocol.
Participant milestones
| Measure |
Males
Male Participants (K-Y Brand TOUCH 2-in-1)
|
Female
Female Participants (K-Y Brand TOUCH 2-in-1)
|
|---|---|---|
|
Overall Study
STARTED
|
62
|
62
|
|
Overall Study
COMPLETED
|
62
|
62
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety Study of a Sensitive Sensual Touch and Personal Lubricant
Baseline characteristics by cohort
| Measure |
Male
n=62 Participants
Male Participants
|
Female
n=62 Participants
Female Participants
|
Total
n=124 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.6 years
STANDARD_DEVIATION 13.8 • n=5 Participants
|
42.0 years
STANDARD_DEVIATION 12.7 • n=7 Participants
|
42.8 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
62 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
51 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
62 participants
n=5 Participants
|
62 participants
n=7 Participants
|
124 participants
n=5 Participants
|
|
Menopausal Status
Premenopausal
|
NA Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Menopausal Status
Postmenopausal
|
NA Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Total Couples with Sensitive Skin
Couple with Male Partner with Sensitive Skin
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Total Couples with Sensitive Skin
Couple with Female Partner with Sensitive Skin
|
0 participants
n=5 Participants
|
46 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
Total Couples with Sensitive Skin
Couple with Both Partners with Sensitive Skin
|
13 participants
n=5 Participants
|
13 participants
n=7 Participants
|
26 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One weekPopulation: Full Analysis Set
Severity of physical irritation scored by the Investigator on a scale from 0 (no irritation) to 6 (presence of lesions). Since a score of 0 is required at baseline for inclusion in the study, this any score represents a change from baseline and the trial is considered baseline-controlled. The number of participants with physical irritation scores after one week was recorded (along with categorical severity).
Outcome measures
| Measure |
Male
n=62 Participants
Male Participants
|
Female
n=62 Participants
Female Participants
|
|---|---|---|
|
Number of Participants With Physical Irritation Scores
Mild Irritation, Genital Region
|
0 Participants
|
1 Participants
|
|
Number of Participants With Physical Irritation Scores
No Irritation, Either Region
|
61 Participants
|
61 Participants
|
|
Number of Participants With Physical Irritation Scores
Mild Irritation, Neck Region
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: One weekPopulation: Full Analysis Set
Participants were asked to rate specific sensations they experienced during each application at each site (genital and neck) on a five-point categorical severity scale from mild to excruciating. The sensations included itching, burning, stinging, tingling, warming, and cooling. The number of participants with subjective irritation scores after one week was recorded.
Outcome measures
| Measure |
Male
n=62 Participants
Male Participants
|
Female
n=62 Participants
Female Participants
|
|---|---|---|
|
Number of Participants Reporting Subjective Irritation - Genital Application 1
Baseline
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Subjective Irritation - Genital Application 1
Itching
|
4 Participants
|
3 Participants
|
|
Number of Participants Reporting Subjective Irritation - Genital Application 1
Burning
|
1 Participants
|
6 Participants
|
|
Number of Participants Reporting Subjective Irritation - Genital Application 1
Stinging
|
1 Participants
|
2 Participants
|
|
Number of Participants Reporting Subjective Irritation - Genital Application 1
Tingling
|
7 Participants
|
13 Participants
|
|
Number of Participants Reporting Subjective Irritation - Genital Application 1
Warming
|
15 Participants
|
22 Participants
|
|
Number of Participants Reporting Subjective Irritation - Genital Application 1
Cooling
|
12 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: One weekPopulation: Full Analysis Set
Participants were asked to rate specific sensations they experienced during each application at each site (genital and neck) on a five-point categorical severity scale from mild to excruciating. The sensations included itching, burning, stinging, tingling, warming, and cooling. The number of participants with subjective irritation scores after one week was recorded.
Outcome measures
| Measure |
Male
n=62 Participants
Male Participants
|
Female
n=62 Participants
Female Participants
|
|---|---|---|
|
Number of Participants Reporting Subjective Irritation - Genital Application 2
Baseline
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Subjective Irritation - Genital Application 2
Itching
|
2 Participants
|
1 Participants
|
|
Number of Participants Reporting Subjective Irritation - Genital Application 2
Burning
|
1 Participants
|
5 Participants
|
|
Number of Participants Reporting Subjective Irritation - Genital Application 2
Stinging
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Subjective Irritation - Genital Application 2
Tingling
|
5 Participants
|
10 Participants
|
|
Number of Participants Reporting Subjective Irritation - Genital Application 2
Warming
|
17 Participants
|
18 Participants
|
|
Number of Participants Reporting Subjective Irritation - Genital Application 2
Cooling
|
12 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: One weekPopulation: Full Analysis Set
Participants were asked to rate specific sensations they experienced during each application at each site (genital and neck) on a five-point categorical severity scale from mild to excruciating. The sensations included itching, burning, stinging, tingling, warming, and cooling. The number of participants with subjective irritation scores after one week was recorded.
Outcome measures
| Measure |
Male
n=62 Participants
Male Participants
|
Female
n=62 Participants
Female Participants
|
|---|---|---|
|
Number of Participants Reporting Subjective Irritation - Neck Application 1
Baseline
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Subjective Irritation - Neck Application 1
Itching
|
1 Participants
|
2 Participants
|
|
Number of Participants Reporting Subjective Irritation - Neck Application 1
Burning
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Subjective Irritation - Neck Application 1
Stinging
|
2 Participants
|
1 Participants
|
|
Number of Participants Reporting Subjective Irritation - Neck Application 1
Tingling
|
4 Participants
|
8 Participants
|
|
Number of Participants Reporting Subjective Irritation - Neck Application 1
Warming
|
10 Participants
|
13 Participants
|
|
Number of Participants Reporting Subjective Irritation - Neck Application 1
Cooling
|
14 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: One weekPopulation: Full Analysis Set
Participants were asked to rate specific sensations they experienced during each application at each site (genital and neck) on a five-point categorical severity scale from mild to excruciating. The sensations included itching, burning, stinging, tingling, warming, and cooling. The number of participants with subjective irritation scores after one week was recorded.
Outcome measures
| Measure |
Male
n=62 Participants
Male Participants
|
Female
n=62 Participants
Female Participants
|
|---|---|---|
|
Number of Participants Reporting Subjective Irritation - Neck Application 2
Baseline
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Subjective Irritation - Neck Application 2
Itching
|
2 Participants
|
4 Participants
|
|
Number of Participants Reporting Subjective Irritation - Neck Application 2
Burning
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Subjective Irritation - Neck Application 2
Stinging
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Subjective Irritation - Neck Application 2
Tingling
|
1 Participants
|
9 Participants
|
|
Number of Participants Reporting Subjective Irritation - Neck Application 2
Warming
|
10 Participants
|
12 Participants
|
|
Number of Participants Reporting Subjective Irritation - Neck Application 2
Cooling
|
16 Participants
|
15 Participants
|
Adverse Events
Male
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Female
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Male
n=62 participants at risk
Male Participants
|
Female
n=62 participants at risk
Female Participants
|
|---|---|---|
|
General disorders
Application Site Pain (e.g., burning, stinging)
|
3.2%
2/62 • 1 Week (+30 days for Serious Adverse Events, and beyond if assessed as possibly treatment related)
Adverse Events were collected from all study subjects via subjective questionnaire and physical examination. Participants are counted one time for each adverse event they experienced.
|
12.9%
8/62 • 1 Week (+30 days for Serious Adverse Events, and beyond if assessed as possibly treatment related)
Adverse Events were collected from all study subjects via subjective questionnaire and physical examination. Participants are counted one time for each adverse event they experienced.
|
|
General disorders
Application Site Pruritus (e.g., itching)
|
6.5%
4/62 • 1 Week (+30 days for Serious Adverse Events, and beyond if assessed as possibly treatment related)
Adverse Events were collected from all study subjects via subjective questionnaire and physical examination. Participants are counted one time for each adverse event they experienced.
|
9.7%
6/62 • 1 Week (+30 days for Serious Adverse Events, and beyond if assessed as possibly treatment related)
Adverse Events were collected from all study subjects via subjective questionnaire and physical examination. Participants are counted one time for each adverse event they experienced.
|
|
General disorders
Application Site Erythema
|
1.6%
1/62 • 1 Week (+30 days for Serious Adverse Events, and beyond if assessed as possibly treatment related)
Adverse Events were collected from all study subjects via subjective questionnaire and physical examination. Participants are counted one time for each adverse event they experienced.
|
3.2%
2/62 • 1 Week (+30 days for Serious Adverse Events, and beyond if assessed as possibly treatment related)
Adverse Events were collected from all study subjects via subjective questionnaire and physical examination. Participants are counted one time for each adverse event they experienced.
|
|
General disorders
Application Site Excoriation
|
0.00%
0/62 • 1 Week (+30 days for Serious Adverse Events, and beyond if assessed as possibly treatment related)
Adverse Events were collected from all study subjects via subjective questionnaire and physical examination. Participants are counted one time for each adverse event they experienced.
|
3.2%
2/62 • 1 Week (+30 days for Serious Adverse Events, and beyond if assessed as possibly treatment related)
Adverse Events were collected from all study subjects via subjective questionnaire and physical examination. Participants are counted one time for each adverse event they experienced.
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
0.00%
0/62 • 1 Week (+30 days for Serious Adverse Events, and beyond if assessed as possibly treatment related)
Adverse Events were collected from all study subjects via subjective questionnaire and physical examination. Participants are counted one time for each adverse event they experienced.
|
1.6%
1/62 • 1 Week (+30 days for Serious Adverse Events, and beyond if assessed as possibly treatment related)
Adverse Events were collected from all study subjects via subjective questionnaire and physical examination. Participants are counted one time for each adverse event they experienced.
|
|
Musculoskeletal and connective tissue disorders
Ankle Fracture
|
1.6%
1/62 • 1 Week (+30 days for Serious Adverse Events, and beyond if assessed as possibly treatment related)
Adverse Events were collected from all study subjects via subjective questionnaire and physical examination. Participants are counted one time for each adverse event they experienced.
|
0.00%
0/62 • 1 Week (+30 days for Serious Adverse Events, and beyond if assessed as possibly treatment related)
Adverse Events were collected from all study subjects via subjective questionnaire and physical examination. Participants are counted one time for each adverse event they experienced.
|
Additional Information
Joyce Hauze, Sr. Specialist
Johnson & Johnson Consumer and Personal Products Worldwide
Phone: 928-277-0715
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Study is considered a work made for hire and the Sponsor retains all rights to publish results.
- Publication restrictions are in place
Restriction type: OTHER