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Dietary Supplement
Clear Skin Formula for Acne
N/A
Recruiting
Research Sponsored by Ablon Skin Institute Research Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects must have a facial non-cystic acne inflammatory lesion (papules and pustules) count with no less than 10 but no more than 50
Subjects must have a facial non-cystic acne non-inflammatory lesion (open and closed comedones) count with no less than 10 but no more than 100
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, day 14, day 28, day 56 and day 84 or end of study (up to 12 weeks)
Awards & highlights
Study Summary
This trial tests a supplement to reduce mild to moderate acne over 12 weeks in 18-40 yo men & women, with photos & questionnaires.
Who is the study for?
Healthy men and women aged 18-40 with mild to moderate non-cystic acne can join this study. They must have a certain number of facial acne lesions, agree to use specific skincare products provided by the sponsor, and for females, practice effective contraception. People using certain medications or treatments, those with other skin conditions or severe health issues, pregnant or nursing women, and individuals unable to follow the study protocol are excluded.Check my eligibility
What is being tested?
The trial is testing VitaMedica® Clear Skin Formula capsules against placebo capsules over 12 weeks in participants with non-cystic acne. It aims to see if the supplement helps reduce acne symptoms better than a placebo. Participants will take daily supplements, have their faces photographed regularly, and answer questionnaires about their skin condition.See study design
What are the potential side effects?
While not explicitly listed in the information provided, potential side effects may include digestive discomforts such as upset stomach or diarrhea since it's an oral supplement. Allergic reactions could occur but are likely rare given that it's designed for sensitive skin conditions like acne.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have between 10 and 50 non-cystic pimples on my face.
Select...
I have between 10 and 100 non-inflammatory acne spots on my face.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, day 14, day 28, day 56 and day 84 or end of study (up to 12 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, day 14, day 28, day 56 and day 84 or end of study (up to 12 weeks)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in inflammatory lesion counts
Change in non-inflammatory lesion counts
Percentage/Proportion of subjects who achieve at least a one-grade reduction in the Modified IGA Score
Secondary outcome measures
Change in Analysis of the Clear Skin Formula Supplement Subject Satisfaction questionnaire
Change in Non-Cystic Acne Quality of Life questionnaire scores
Change in Non-Cystic Acne Self Assessment questionnaire scores
Other outcome measures
Change in the VISIA photography imaging of the left, right and front views of the face to include the (1) Percentile Rating, (2) Score Rating and (3) Feature Count Rating for Wrinkles, Texture, Pores, Red Areas and Porphyrins.
Changes in Clinical laboratory analyses of Complete Blood Count without Differential and with Platelets
Changes in Clinical laboratory analyses of Complete Metabolic Panel
+3 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: VitaMedica® Clear Skin Formula capsulesActive Control1 Intervention
Storage Instructions: Store in a cool, dry place. Contents: 60 Capsules Directions for Use: As a dietary supplement, take two capsules with food. Caution: Do not take if safety seal on bottle is broken. KEEP OUT OF REACH OF CHILDREN.
Group II: Placebo CapsulesPlacebo Group1 Intervention
Storage Instructions: Store in a cool, dry place. Contents: 60 Capsules Directions for Use: As a dietary supplement, take two capsules with food. Caution: Do not take if safety seal on bottle is broken. KEEP OUT OF REACH OF CHILDREN.
Find a Location
Who is running the clinical trial?
Grove Acquisition Subsidiary dba VitaMedicaUNKNOWN
Ablon Skin Institute Research CenterLead Sponsor
6 Previous Clinical Trials
296 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have over 100 non-painful acne bumps on my face.I am a woman with a history of excessive hair growth, polycystic ovarian disease, or irregular periods.I don't have skin conditions on my face that need strong treatments.I haven't used certain skin treatments on my face for the required time before starting this trial.I am using or willing to use effective birth control for the study's duration.I am willing to use only the skin products provided by the study.I haven't taken high-dose vitamin A, steroids, antibiotics, or other systemic treatments recently.I am between 18 and 40 years old and consider my skin healthy.I haven't used any experimental drugs or devices in the last 30 days.I am not pregnant, nursing, planning to become pregnant, or become pregnant during the study.You have a history of feeling strong burning or stinging when using any facial treatment on your face.You must have mild or moderate symptoms according to the doctor's evaluation at the start of the study.I have between 10 and 50 non-cystic pimples on my face.I am willing to follow the study rules and visit the clinic as needed.I am willing and able to fill out and understand study questionnaires.I will be clean-shaven for all study visits.I do not have severe skin conditions on my face that could affect study assessments.You have a beard or mustache that could make it difficult to do the assessments for the study.I have more than 50 non-cystic pimples on my face.I have cysts due to acne on my face.I have a history of chronic bowel conditions or severe diarrhea.I can communicate and cooperate with my doctor without issues.I am willing and able to follow the study's daily requirements and attend all visits.I haven't had cancer treatment in the last 6 months, except for skin cancer surgery.I have between 10 and 100 non-inflammatory acne spots on my face.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo Capsules
- Group 2: VitaMedica® Clear Skin Formula capsules
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment being offered to those of advanced age for this medical investigation?
"Per the study's eligibility requirements, only adults between 18 and 40 years old can take part in this research."
Answered by AI
Could I potentially join this research endeavor?
"Eligibility for this trial is limited to individuals between 18-40 years old that suffer from non-cystic acne. As of now, 40 patients are slated to be enrolled in the study."
Answered by AI
How many participants are engaging in this clinical research study?
"Affirmative. Information posted on clinicaltrials.gov demonstrates that this medical study is actively recruiting subjects, which began with the posting from May 22nd 2023 and was last updated 19th of May 2023. The research team requires 40 participants to be enrolled at 1 site."
Answered by AI
Is this experiment actively enrolling participants?
"Affirmative. According to clinicaltrials.gov, this current medical trial was first posted on May 22nd 2023 and has recently been updated as of May 19th 2023. The study is in search for 40 participants amongst a single location."
Answered by AI
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