A Clinical study to evaluate the Non-Comedogenic Effect of Reginald Men Serum on Healthy Human Volunteers
Trial Snapshot
- Phase
- Unknown
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- 1. Change in Comedone count (Retentional lessons)
Study Overview
Brief Summary
A single blind one arm study.
Subjects must have not more than 25 facial lesions, which are predominately open and closed comedones. A board-certified dermatologist evaluates the lesions on the face and the results are recorded.
Typically, the subject uses the test material on the face for 4 weeks. For a 4-week trial, evaluations occur after 2 weeks (optional) and 4 weeks of test material use.
A board-certified dermatologist evaluates the lesions on the face and the results are recorded. Differences between baseline and interim or final evaluations are considered statistically significant if the probability of obtaining the results by chance is ≤0.050 using analysis of variance and/or 1-test statistical analysis.
Assessment: Count of number of retentional lesions[Comedones] (closed comedones and opened comedones) and/or inflammatory lesions (papules, pustules and excoriated lesions).
Assessment Time: Day0 and Day28
Assessments:
1. Face Imaging: At Day 0 ad Day 28 2. Sebum Count By Sebumeter : At Day 0 ad Day 28
3. Change in Comedone count
4. Change in inflammatory lesions
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 45.00 Year(s) (—)
Inclusion Criteria
- •Gender: Male or Female with age 18-45 2)Having oily or mixed oily skin on the face.
- •Subjects willing to give written informed consent 4)Women of child bearing potential must have a negative urine pregnancy test prior to study entry.
- •Are free of any systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events.
- •Are willing to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural or artificial) for the duration of the study.
Exclusion Criteria
- •Subjects who are pregnant, breast-feeding, or planning to become pregnant during the study.
- •Have any evidence of systemic cancer, squamous cell carcinoma, basal cell carcinoma, in the last 5 years, or any other confounding skin condition.
- •Have any condition that, in the opinion of the investigator, would confound the safety and/or efficacy assessments of the product.
- •Have participated in any interventional clinical trial in the previous 30 days.
- •Have a known sensitivity to any of the constituents of the test product including sensitivities to the test product ingredients
- •Have used, are using, or are planning to use immunosuppressive or immunomodulatory medication (i.e., biologics), including corticosteroids.
- •Having applied hair oil during the entire duration of the study
- •No Chronic illness.
Outcomes
Primary Outcomes
1. Change in Comedone count (Retentional lessons)
Time Frame: At t0, t+14days, t+28days
2. Change in inflammatory lessons
Time Frame: At t0, t+14days, t+28days
3. Sebum Count By Sebumeter
Time Frame: At t0, t+14days, t+28days
4. Face Imaging
Time Frame: At t0, t+14days, t+28days
Secondary Outcomes
- Not Applicable(Not Applicable)
Investigators
Dr Robin Chugh
CCFT Laboratories