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Trial Outcomes & Findings for Pre-Shave Gel and Brush in Pseudofolliculitis Barbae (NCT NCT03043534)

NCT ID: NCT03043534

Last Updated: 2018-12-19

Results Overview

A total of the Patient's Global Assessment of mechanics of shaving based on following scale: How easy is it to… (please rank each phrase from 1 to 4; 1 = very easy, 2 = easy, 3 = difficult, 4 = very difficult) A) get a smooth shave after shaving? \_\_\_\_\_\_\_\_\_\_ B) shave stubborn hairs? \_\_\_\_\_\_\_\_\_\_ C) shave against the grain with little irritation? \_\_\_\_\_\_\_\_\_\_ D) shave with the grain with little irritation? \_\_\_\_\_\_\_\_\_\_ E) glide comfortably over your skin with the razor blade? For each subject, the total score could range from 5 -20, with lower numbers indicating better shave mechanics

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

29 participants

Primary outcome timeframe

Baseline, 6 weeks

Results posted on

2018-12-19

Participant Flow

Participant milestones

Participant milestones
Measure
Gel and Brush
The Experimental group of subjects will be given the study product Pre-Shave Gel and Brush. The gel and brush will be used prior to their normal shave routine. Subjects will shave at least 3 times weekly. shave gel: Non marketed pre-shave gel with the following INCI list of ingredients: WATER, GLYCERIN, DIMETHICONE, LAURETH-23, PETROLATUM, ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER, ISOPROPYL PALMITATE, HYDROXYETHYLCELLULOSE, FRAGRANCE, PEG-23M, C13-14 ISOPARAFFIN, DMDM HYDANTOIN, DISODIUM EDTA, LAURETH-7, IODOPROPYNYL BUTYLCARBAMATE Brush: All subjects randomized to brush will use the brush with each shave
Control
Subjects will use their normal razors and shave products during the six week study. Subjects must shave at least 3 times weekly. No change in normal shaving is done in this group
Overall Study
STARTED
15
14
Overall Study
COMPLETED
15
14
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pre-Shave Gel and Brush in Pseudofolliculitis Barbae

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Gel and Brush
n=15 Participants
The Experimental group of subjects will be given the study product Pre-Shave Gel and Brush. The gel and brush will be used prior to their normal shave routine. Subjects will shave at least 3 times weekly. shave gel: Non marketed pre-shave gel with the following INCI list of ingredients: WATER, GLYCERIN, DIMETHICONE, LAURETH-23, PETROLATUM, ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER, ISOPROPYL PALMITATE, HYDROXYETHYLCELLULOSE, FRAGRANCE, PEG-23M, C13-14 ISOPARAFFIN, DMDM HYDANTOIN, DISODIUM EDTA, LAURETH-7, IODOPROPYNYL BUTYLCARBAMATE Brush: All subjects randomized to brush will use the brush with each shave
Control
n=14 Participants
Subjects will use their normal razors and shave products during the six week study. Subjects must shave at least 3 times weekly. No change in normal shaving is done in this group
Total
n=29 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
15 Participants
n=5 Participants
14 Participants
n=7 Participants
29 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
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
15 Participants
n=5 Participants
14 Participants
n=7 Participants
29 Participants
n=5 Participants
Region of Enrollment
United States
15 Participants
n=5 Participants
14 Participants
n=7 Participants
29 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 6 weeks

A total of the Patient's Global Assessment of mechanics of shaving based on following scale: How easy is it to… (please rank each phrase from 1 to 4; 1 = very easy, 2 = easy, 3 = difficult, 4 = very difficult) A) get a smooth shave after shaving? \_\_\_\_\_\_\_\_\_\_ B) shave stubborn hairs? \_\_\_\_\_\_\_\_\_\_ C) shave against the grain with little irritation? \_\_\_\_\_\_\_\_\_\_ D) shave with the grain with little irritation? \_\_\_\_\_\_\_\_\_\_ E) glide comfortably over your skin with the razor blade? For each subject, the total score could range from 5 -20, with lower numbers indicating better shave mechanics

Outcome measures

Outcome measures
Measure
Gel and Brush
n=15 Participants
The Experimental group of subjects will be given the study product Pre-Shave Gel and Brush. The gel and brush will be used prior to their normal shave routine. Subjects will shave at least 3 times weekly. shave gel: Non marketed pre-shave gel with the following INCI list of ingredients: WATER, GLYCERIN, DIMETHICONE, LAURETH-23, PETROLATUM, ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER, ISOPROPYL PALMITATE, HYDROXYETHYLCELLULOSE, FRAGRANCE, PEG-23M, C13-14 ISOPARAFFIN, DMDM HYDANTOIN, DISODIUM EDTA, LAURETH-7, IODOPROPYNYL BUTYLCARBAMATE Brush: All subjects randomized to brush will use the brush with each shave
Control
n=14 Participants
Subjects will use their normal razors and shave products during the six week study. Subjects must shave at least 3 times weekly. No change in normal shaving is done in this group
Patient Global Severity Assessment- Mechanics of Shaving
Baseline
12.9 score on a scale
Standard Deviation 2.6
12.4 score on a scale
Standard Deviation 3.2
Patient Global Severity Assessment- Mechanics of Shaving
Week 6
8.5 score on a scale
Standard Deviation 4.1
9.7 score on a scale
Standard Deviation 4.8

SECONDARY outcome

Timeframe: Baseline, 6 weeks

Patient Global Severity Assessment measures itching/burning/stinging on the following scales:1 (no itching/no burning/no stinging at all) to 5 (very severe) the total score could range from 1-5 with the lower scores promoting a better outcome.

Outcome measures

Outcome measures
Measure
Gel and Brush
n=15 Participants
The Experimental group of subjects will be given the study product Pre-Shave Gel and Brush. The gel and brush will be used prior to their normal shave routine. Subjects will shave at least 3 times weekly. shave gel: Non marketed pre-shave gel with the following INCI list of ingredients: WATER, GLYCERIN, DIMETHICONE, LAURETH-23, PETROLATUM, ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER, ISOPROPYL PALMITATE, HYDROXYETHYLCELLULOSE, FRAGRANCE, PEG-23M, C13-14 ISOPARAFFIN, DMDM HYDANTOIN, DISODIUM EDTA, LAURETH-7, IODOPROPYNYL BUTYLCARBAMATE Brush: All subjects randomized to brush will use the brush with each shave
Control
n=14 Participants
Subjects will use their normal razors and shave products during the six week study. Subjects must shave at least 3 times weekly. No change in normal shaving is done in this group
Patient Global Severity Assessment (Degree of Itching, Burning and Stinging)
Baseline
2.33 score on a scale
Standard Deviation 1.04
2.64 score on a scale
Standard Deviation 1.00
Patient Global Severity Assessment (Degree of Itching, Burning and Stinging)
Week 6
1.46 score on a scale
Standard Deviation 0.74
1.85 score on a scale
Standard Deviation 0.94

SECONDARY outcome

Timeframe: Baseline, 6 weeks

Quality of Life Survey will measure subjects' overall perception. For Shaving Experience, the total score could range from 6-42 with lower scores denoting better outcome measures. For Shaving Frustration, the total score could range from 3-21 with higher scores denoting better outcome measures. For Achieving Results, the total score could range from 3-21 with lower scores denoting better outcome measures. For Skin Feel, the total score could range from 3-21 with lower scores denoting better outcome measures. For Skin-Confidence, the total score could range from 4-28 with lower scores denoting better outcome measures. For Social Interactions, the total score could range from 6-42 with lower scores denoting better outcome measures.

Outcome measures

Outcome measures
Measure
Gel and Brush
n=15 Participants
The Experimental group of subjects will be given the study product Pre-Shave Gel and Brush. The gel and brush will be used prior to their normal shave routine. Subjects will shave at least 3 times weekly. shave gel: Non marketed pre-shave gel with the following INCI list of ingredients: WATER, GLYCERIN, DIMETHICONE, LAURETH-23, PETROLATUM, ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER, ISOPROPYL PALMITATE, HYDROXYETHYLCELLULOSE, FRAGRANCE, PEG-23M, C13-14 ISOPARAFFIN, DMDM HYDANTOIN, DISODIUM EDTA, LAURETH-7, IODOPROPYNYL BUTYLCARBAMATE Brush: All subjects randomized to brush will use the brush with each shave
Control
n=14 Participants
Subjects will use their normal razors and shave products during the six week study. Subjects must shave at least 3 times weekly. No change in normal shaving is done in this group
Quality of Life Survey
Baseline Shaving Experience
24.6 score on a scale
Standard Deviation 10.3
23.5 score on a scale
Standard Deviation 6.51
Quality of Life Survey
Baseline Shaving Frustrations
13 score on a scale
Standard Deviation 5.38
11.4 score on a scale
Standard Deviation 2.59
Quality of Life Survey
Baseline Achieving Results
12 score on a scale
Standard Deviation 4.88
11.4 score on a scale
Standard Deviation 4.55
Quality of Life Survey
Baseline Skin Feel
13.2 score on a scale
Standard Deviation 4.60
10.7 score on a scale
Standard Deviation 4.59
Quality of Life Survey
Baseline Skin-Confidence
16.3 score on a scale
Standard Deviation 6.49
13.9 score on a scale
Standard Deviation 5.2
Quality of Life Survey
Baseline Social Interactions
19.4 score on a scale
Standard Deviation 8.8
17.8 score on a scale
Standard Deviation 5.6
Quality of Life Survey
Week 6 Shaving Experience
12.5 score on a scale
Standard Deviation 6.24
20.5 score on a scale
Standard Deviation 6.5
Quality of Life Survey
Week 6 Shaving Frustrations
14.6 score on a scale
Standard Deviation 4.8
9.9 score on a scale
Standard Deviation 2.9
Quality of Life Survey
Week 6 Achieving Results
7.6 score on a scale
Standard Deviation 5.1
8.0 score on a scale
Standard Deviation 4.0
Quality of Life Survey
Week 6 Skin Feel
6.5 score on a scale
Standard Deviation 5.0
8.5 score on a scale
Standard Deviation 4.6
Quality of Life Survey
Week 6 Self-Confidence
10.8 score on a scale
Standard Deviation 6.5
10.3 score on a scale
Standard Deviation 5.2
Quality of Life Survey
Week 6 Social Interactions
16.9 score on a scale
Standard Deviation 10.4
13.3 score on a scale
Standard Deviation 6.5

SECONDARY outcome

Timeframe: Baseline, 6 weeks

Lesions will be measured by counting papules, pustules, ingrown hairs, and Hyerpigmentation.

Outcome measures

Outcome measures
Measure
Gel and Brush
n=15 Participants
The Experimental group of subjects will be given the study product Pre-Shave Gel and Brush. The gel and brush will be used prior to their normal shave routine. Subjects will shave at least 3 times weekly. shave gel: Non marketed pre-shave gel with the following INCI list of ingredients: WATER, GLYCERIN, DIMETHICONE, LAURETH-23, PETROLATUM, ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER, ISOPROPYL PALMITATE, HYDROXYETHYLCELLULOSE, FRAGRANCE, PEG-23M, C13-14 ISOPARAFFIN, DMDM HYDANTOIN, DISODIUM EDTA, LAURETH-7, IODOPROPYNYL BUTYLCARBAMATE Brush: All subjects randomized to brush will use the brush with each shave
Control
n=14 Participants
Subjects will use their normal razors and shave products during the six week study. Subjects must shave at least 3 times weekly. No change in normal shaving is done in this group
Lesions
Baseline
23.7 lesions
Standard Deviation 24.2
20.3 lesions
Standard Deviation 2.1
Lesions
Week 6
19.4 lesions
Standard Deviation 18.5
16.1 lesions
Standard Deviation 2.1

SECONDARY outcome

Timeframe: Baseline, 6 weeks

Investigator Global Assessment (IGA) will measure disease severity using a scale 0 (Clear) - 5 (Very Severe) with the lower score grade denoting better outcome measures.

Outcome measures

Outcome measures
Measure
Gel and Brush
n=15 Participants
The Experimental group of subjects will be given the study product Pre-Shave Gel and Brush. The gel and brush will be used prior to their normal shave routine. Subjects will shave at least 3 times weekly. shave gel: Non marketed pre-shave gel with the following INCI list of ingredients: WATER, GLYCERIN, DIMETHICONE, LAURETH-23, PETROLATUM, ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER, ISOPROPYL PALMITATE, HYDROXYETHYLCELLULOSE, FRAGRANCE, PEG-23M, C13-14 ISOPARAFFIN, DMDM HYDANTOIN, DISODIUM EDTA, LAURETH-7, IODOPROPYNYL BUTYLCARBAMATE Brush: All subjects randomized to brush will use the brush with each shave
Control
n=14 Participants
Subjects will use their normal razors and shave products during the six week study. Subjects must shave at least 3 times weekly. No change in normal shaving is done in this group
Investigator Global Assessment (IGA)
Baseline
2.73 units on a scale
Standard Deviation 0.79
2.57 units on a scale
Standard Deviation 0.75
Investigator Global Assessment (IGA)
Week 6
2.06 units on a scale
Standard Deviation 1.38
2.26 units on a scale
Standard Deviation 0.85

Adverse Events

Gel and Brush

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control

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

Dr Amy McMichael

WakeForest

Phone: 336-716-3775

Results disclosure agreements

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