ClinicalTrials.gov
ClinicalTrials.gov Menu

Pre-Shave Gel and Brush in Pseudofolliculitis Barbae

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03043534
Recruitment Status : Completed
First Posted : February 6, 2017
Results First Posted : July 2, 2017
Last Update Posted : December 18, 2018
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Pseudofolliculitis Barbae
Interventions Other: shave gel
Other: Brush
Enrollment 29
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Gel and Brush Control
Hide Arm/Group Description

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

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
Period Title: Overall Study
Started 15 14
Completed 15 14
Not Completed 0 0
Arm/Group Title Gel and Brush Control Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 15 14 29
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 14 participants 29 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
15
 100.0%
14
 100.0%
29
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 14 participants 29 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
15
 100.0%
14
 100.0%
29
 100.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 15 participants 14 participants 29 participants
15
 100.0%
14
 100.0%
29
 100.0%
1.Primary Outcome
Title Patient Global Severity Assessment- Mechanics of Shaving
Hide Description

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

Time Frame Baseline, 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gel and Brush Control
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 15 14
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 12.9  (2.6) 12.4  (3.2)
Week 6 8.5  (4.1) 9.7  (4.8)
2.Secondary Outcome
Title Patient Global Severity Assessment (Degree of Itching, Burning and Stinging)
Hide Description 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.
Time Frame Baseline, 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gel and Brush Control
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 15 14
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 2.33  (1.04) 2.64  (1.00)
Week 6 1.46  (0.74) 1.85  (0.94)
3.Secondary Outcome
Title Quality of Life Survey
Hide Description

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.

Time Frame Baseline, 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gel and Brush Control
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 15 14
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Shaving Experience 24.6  (10.3) 23.5  (6.51)
Baseline Shaving Frustrations 13  (5.38) 11.4  (2.59)
Baseline Achieving Results 12  (4.88) 11.4  (4.55)
Baseline Skin Feel 13.2  (4.60) 10.7  (4.59)
Baseline Skin-Confidence 16.3  (6.49) 13.9  (5.2)
Baseline Social Interactions 19.4  (8.8) 17.8  (5.6)
Week 6 Shaving Experience 12.5  (6.24) 20.5  (6.5)
Week 6 Shaving Frustrations 14.6  (4.8) 9.9  (2.9)
Week 6 Achieving Results 7.6  (5.1) 8.0  (4.0)
Week 6 Skin Feel 6.5  (5.0) 8.5  (4.6)
Week 6 Self-Confidence 10.8  (6.5) 10.3  (5.2)
Week 6 Social Interactions 16.9  (10.4) 13.3  (6.5)
4.Secondary Outcome
Title Lesions
Hide Description Lesions will be measured by counting papules, pustules, ingrown hairs, and Hyerpigmentation.
Time Frame Baseline, 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gel and Brush Control
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 15 14
Mean (Standard Deviation)
Unit of Measure: lesions
Baseline 23.7  (24.2) 20.3  (2.1)
Week 6 19.4  (18.5) 16.1  (2.1)
5.Secondary Outcome
Title Investigator Global Assessment (IGA)
Hide Description 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.
Time Frame Baseline, 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gel and Brush Control
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 15 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 2.73  (0.79) 2.57  (0.75)
Week 6 2.06  (1.38) 2.26  (0.85)
Time Frame 6 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Gel and Brush Control
Hide Arm/Group Description

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

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
All-Cause Mortality
Gel and Brush Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/14 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Gel and Brush Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/14 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Gel and Brush Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/14 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr Amy McMichael
Organization: WakeForest
Phone: 336-716-3775
Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03043534     History of Changes
Other Study ID Numbers: IRB00034479
First Submitted: January 31, 2017
First Posted: February 6, 2017
Results First Submitted: April 19, 2017
Results First Posted: July 2, 2017
Last Update Posted: December 18, 2018