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 : August 16, 2017
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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

Participant Flow:   Overall Study
    Gel and Brush   Control
STARTED   15   14 
COMPLETED   15   14 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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
Total Total of all reporting groups

Baseline Measures
   Gel and Brush   Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 15   14   29 
Age 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      0   0.0%      0   0.0% 
Male      15 100.0%      14 100.0%      29 100.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   15   14   29 


  Outcome Measures

1.  Primary:   Patient Global Severity   [ Time Frame: 6 weeks ]

2.  Secondary:   Mechanics of Shaving   [ Time Frame: 6 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: amcmicha@wakehealth.edu



Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03043534     History of Changes
Other Study ID Numbers: 0034479
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: August 16, 2017