Pseudofolliculitis BarbaeNCT03043534
Pre-Shave Gel and Brush in Pseudofolliculitis Barbae
A study testing shave gel and Brush in people with Pseudofolliculitis Barbae, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
This will be a randomized investigator blinded study of 40 men age 20-60 (inclusive) with symptoms of mild-moderate PFB based on Investigator Global Assessment (IGA). Subjects will be divided into two groups: the Control group of 20 subjects and the Experimental group of 20 Subjects. Read more about this study
- Who is it for?
- Ages 20 to 60 years, men only
- Conditions the study is for
- Pseudofolliculitis Barbae
- What is being tested?
- shave gel and Brush
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2015to 12 Oct 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Males with at least a two year history of the symptoms of PFB.
- Must be age 20-60 years of age (inclusive).
- Must wet shave using just a prep and blade razor at least 3 or more times per week, and be willing to continue that regimen during the study.
- Must have Mild -to moderate PFB based on IGA rating scales. There are no lesion count inclusion requirements.
Who cannot join
- Use of systemic (oral antibiotics) within the last 4 weeks.
- Use of topical prescriptions (topical clindamycin, topical retinoids, topical metronidazole, topical sulfacetamide/sulfur, topical adapalene, benzoyl peroxide, salicylic acid, glycolic acid, retinol,chemical peels) or over-the-counter products the subject has used for PFB or Hair Growth within the last 2 weeks. Use of oral retinoids, laser therapy or electrolysis treatments or waxing in beard area in last 12 months.
- Individuals who do not wet shave with a bladed razor, or who use electric shavers.
- Subjects must not have used any type of cleansing or shave brush to the face for six weeks prior to Baseline.
- Individuals who have removed a beard within last two months.
- Individuals who have a history of alopecia areata of the face.
Show all 16Show fewer
- Confounding dermatological conditions that would, in the opinion of the principal investigator, preclude participation in this study such as:
- Immune deficiency disease (HIV positive, AIDS, sarcoidosis)
- On immunosuppressive drugs (e.g. oral corticosteroids)
- Autoimmune disease (lupus, scleroderma, diabetes mellitus, vitiligo)
- Koebnerizing diseases (e.g. psoriasis, lichens planus, (HPV) human papilloma virus, facial verruca, molluscum contagiosum)
- Tuberculosis, Hepatitis B
- History of Keloids
- History of Herpes simplex in treated area
- Bacterial infection of face including abscesses and draining sinuses of facial area
- Cystic Acne, other acne in bearded area which interferes with shaving as well as the ability to distinguish PFB lesions from acne
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences Dept of Dermatology
Winston-Salem, North Carolina, 27104
About this study
Official title: The Impact of a Pre-Shave Gel and Brush in Males With Pseudofolliculitis Barbae
This will be a randomized investigator blinded study of 40 men age 20-60 (inclusive) with symptoms of mild-moderate PFB based on Investigator Global Assessment (IGA). Subjects will be divided into two groups: the Control group of 20 subjects and the Experimental group of 20 Subjects. Subjects will be seen at Screening/Baseline, and 6 weeks.
All subjects will use their normal razors and shave products during the six week study. The Experimental group of subjects will also be given the study product Pre-Shave Gel and Cleansing Brush.
Read the detailed description
This will be a randomized investigator blinded study of up to 40 men age 20-60 (inclusive) with symptoms of mild-moderate PFB based on Investigator Global Assessment (IGA). Subjects will be divided into two groups: the Control group of 20 subjects and the Experimental group of 20 Subjects. Subjects will be seen at Screening/Baseline, and 6 weeks.
All subjects will use their normal razors and shave products during the six week study. The Experimental group of subjects will also be given the study product Pre-Shave Gel and Cleansing Brush. The study gel and brush will be used prior to their normal shave routine.Quantitative lesion counts will be done by trained clinicians at each visit. Efficacy assessments include Investigator Global Assessment (IGA) scoring
- Conditions
- Pseudofolliculitis Barbae
- Being tested
- shave gel, Brush
- Medical subject headings
- pseudofolliculitis barbae
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
shave gelOther
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
BrushOther
Also called Oil of Olay cleansing brush
All subjects randomized to brush will use the brush with each shave
| Study group | Role | What they receive |
|---|---|---|
| Gel and Brush | Experimental | 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. Receives: Other: shave gel; Other: Brush |
| Control | No intervention | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Global Severity Assessment- Mechanics of Shaving
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)
- get a smooth shave after shaving? __________
- shave stubborn hairs? __________
- shave against the grain with little irritation? __________
- shave with the grain with little irritation? __________
- 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
Measured: Baseline, 6 weeks
Secondary outcomes (4)
Patient Global Severity Assessment (Degree of Itching, Burning and Stinging)
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.
Measured: Baseline, 6 weeks
Quality of Life Survey
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.
Measured: Baseline, 6 weeks
Lesions
Lesions will be measured by counting papules, pustules, ingrown hairs, and Hyerpigmentation.
Measured: Baseline, 6 weeks
Investigator Global Assessment (IGA)
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.
Measured: Baseline, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2017 (estimated)
- Study start12 Nov 2015
- Primary completion12 Oct 2016
- Study completion12 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pseudofolliculitis BarbaeStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amy McMIchael, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03043534
- Sponsor's protocol ID
- IRB00034479
- Status last verified
- Nov 2018
- First submitted
- 31 Jan 2017
- Last updated
- 19 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Pre-Shave Gel and Brush in Males With Pseudofolliculitis Barbae
- ClinicalTrials.gov ID
- NCT03043534
- Acronym / sponsor ID
- IRB00034479
- Conditions
- Pseudofolliculitis Barbae
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 12 Nov 2015 (actual)
- Primary completion
- 12 Oct 2016 (actual)
- Study completion
- 12 Oct 2016 (actual)
- First posted
- 6 Feb 2017 (estimated)
- Results
- Posted 2 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a randomized investigator blinded study of 40 men age 20-60 (inclusive) with symptoms of mild-moderate PFB based on Investigator Global Assessment (IGA). Subjects will be divided into two groups: the Control group of 20 subjects and the Experimental group of 20 Subjects. Subjects will be seen at Screening/Baseline, and 6 weeks.
All subjects will use their normal razors and shave products during the six week study. The Experimental group of subjects will also be given the study product Pre-Shave Gel and Cleansing Brush.
Detailed description
This will be a randomized investigator blinded study of up to 40 men age 20-60 (inclusive) with symptoms of mild-moderate PFB based on Investigator Global Assessment (IGA). Subjects will be divided into two groups: the Control group of 20 subjects and the Experimental group of 20 Subjects. Subjects will be seen at Screening/Baseline, and 6 weeks.
All subjects will use their normal razors and shave products during the six week study. The Experimental group of subjects will also be given the study product Pre-Shave Gel and Cleansing Brush. The study gel and brush will be used prior to their normal shave routine.Quantitative lesion counts will be done by trained clinicians at each visit. Efficacy assessments include Investigator Global Assessment (IGA) scoring
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gel and Brush | Experimental | Other: shave gel, Other: BrushThe 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. |
| Control | No intervention | –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 |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Males with at least a two year history of the symptoms of PFB.
- Must be age 20-60 years of age (inclusive).
- Must wet shave using just a prep and blade razor at least 3 or more times per week, and be willing to continue that regimen during the study.
- Must have Mild -to moderate PFB based on IGA rating scales. There are no lesion count inclusion requirements.
Key exclusion criteria (16 listed)
- Use of systemic (oral antibiotics) within the last 4 weeks.
- Use of topical prescriptions (topical clindamycin, topical retinoids, topical metronidazole, topical sulfacetamide/sulfur, topical adapalene, benzoyl peroxide, salicylic acid, glycolic acid, retinol,chemical peels) or over-the-counter products the subject has used for PFB or Hair Growth within the last 2 weeks. Use of oral retinoids, laser therapy or electrolysis treatments or waxing in beard area in last 12 months.
- Individuals who do not wet shave with a bladed razor, or who use electric shavers.
- Subjects must not have used any type of cleansing or shave brush to the face for six weeks prior to Baseline.
- Individuals who have removed a beard within last two months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| shave gelNon 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 | Other | Gel and Brush |
| BrushAlso: Oil of Olay cleansing brushAll subjects randomized to brush will use the brush with each shave | Other | Gel and Brush |
Primary outcome
Patient Global Severity Assessment- Mechanics of Shaving
Time frame: 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
4 secondary outcomes
Patient Global Severity Assessment (Degree of Itching, Burning and Stinging)
Time frame: Baseline, 6 weeks
Quality of Life Survey
Time frame: Baseline, 6 weeks
Lesions
Time frame: Baseline, 6 weeks
Investigator Global Assessment (IGA)
Time frame: Baseline, 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Pseudofolliculitis Barbae
Active, not recruiting
Shaving Satisfaction in Males With Skin Irritation From Shaving
Pseudofolliculitis Barbae
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy McMIchael, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing shave gel and Brush in people with Pseudofolliculitis Barbae, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Global Severity Assessment- Mechanics of Shaving (time frame: Baseline, 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2018.