Acne VulgarisNCT04937374
Efficacy and Tolerability of Rehmannia Glutinosa Leaf Extract in the Treatment of Acne Vulgaris
A study testing Rehmannia glutinosa leaf extract and Microcrystalline Cellulose (MCC) in people with Acne Vulgaris, run by Vedic Lifesciences Pvt. Ltd. at 1 site in India.
Trial summary
In this study, The Investigator will be assessing the efficacy and tolerability of Rehmannia glutinosa Libosch leaf-based extract formulation consumption on the treatment of Acne Vulgaris in a randomized, double-blind, placebo-controlled study for the duration of 56 days. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Rehmannia glutinosa leaf extract and Microcrystalline Cellulose (MCC)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteIndia
- Study dates
- 5 Jun 2021to 4 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Females aged 18 to 35 years
- Body Mass Index (BMI) in the range of ≥ 18.5 to ≤ 29.9 kg/m2.
- Moderate to severe acne as per GAGS (defined with a score of 19 to 38)
- Participants ready to continue usual skin care regime till the entirety of study duration.
- Participant willing to abstain Anti-acne preparations (creams, face wash, home remedies, etc) throughout the study.
- Participants must be ready to abstain from any food supplements or medications and other related products apart from the ones allowed during the study period.
- Participants must be willing to complete all study designated questionnaires and diaries or any other related procedures or requirements.
- Participants having the ability to understand and sign a written informed consent form.
Who cannot join
- Unwilling to forgo any aesthetic or dermatological treatments or procedures during the study period.
- Consumption of any over-the-counter or prescribed oral anti-acne medications during the last 3 months prior to screening
- Currently applying any over-the-counter or prescribed anti-acne medication including, but not limited to, retinoic acid or benzoyl peroxide over the past 3 months prior to screening.
- Participants who have used facial, topical or injectable steroids 6 weeks prior to screening and during the study.
- Females suffering from Polycystic Ovary Syndrome (PCOS).
- Participant using oil and oil-based preparations for skin.
Show all 24Show fewer
- Consumptions of any herbal preparation, supplements, nutritional therapy or any other medications that is expected to improve acne over the past two weeks from randomization.
- History of Hormonal imbalance
- Abnormal Thyroid Stimulating Hormone (TSH) value which is < 0.35 or > 4.94 µIU/mL.
- Participant with high caffeine consumption, (defined as >3 cups of coffee consumption in a day).
- Topical or systemic use of antifungals and antibiotics in the previous 2 weeks prior to screening.
- Participant having extremely oily food habits.
- Participants taking drugs known to be photosensitizers including, but not limited to, phenothiazines, amiodarone, quinine, thiazides, tetracyclines, sulphonamides, quinolones
- Known sensitivity to the investigational product or any excipients of the drug product.
- Smoking or using any tobacco products.
- Having a history of chronic skin allergies.
- History of any significant neurological and psychiatric condition which may affect the participation and inference of the study's end points.
- Participation in other clinical trials in last 30 days prior to screening
- Participants with substance abuse problems (within 2 years) defined as:
- Use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.)/Nicotine dependence.
- High-risk drinking as defined by consumption of 4 or more alcohol containing beverages on any day or 8 or more alcohol containing beverages per week for women.
- Patients who have clinically significant following severe illness (i.e., Cardiovascular, endocrine system, immune system, respiratory system, hepatobiliary system, kidney and urinary system, neuropsychiatric, musculoskeletal, inflammatory, blood and tumors, gastrointestinal diseases, etc.)
- Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives.
- Any condition that could, in the opinion of the investigator, preclude the participant's ability to successfully and safely complete the study or that may confound study outcomes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Tolerability of Rehmannia Glutinosa Leaf Extract in the Treatment of Acne Vulgaris: a Double Blinded, Randomized, Placebo-controlled Clinical Trial
In this study, The Investigator will be assessing the efficacy and tolerability of Rehmannia glutinosa Libosch leaf-based extract formulation consumption on the treatment of Acne Vulgaris in a randomized, double-blind, placebo-controlled study for the duration of 56 days.
Read the detailed description
In this study, The Investigator will be assessing the efficacy and tolerability of Rehmannia glutinosa Libosch leaf-based extract formulation consumption on the treatment of Acne Vulgaris in a randomized, double-blind, placebo-controlled study. The participants will consume one capsule per day containing active ingredient for the duration of 56 days. Throughout the duration of the clinical trial, The Investigator will be studying the formulation's effects on the change in the Global Acne Grading System (GAGS) score, facial sebum secretion, the number and irritability of inflammatory lesions, quality of life via the Acne-QoL questionnaire, skin wrinkle severity through the Modified Fitzpatrick Wrinkle Severity Scale (MFWS) and the percentage population of responders at the end of the study. The Investigator will also assess the change in skin radiance, luminosity, smoothness, texture, firmness, and skin hydration through a participant based self-assessment questionnaire as well as the safety and tolerability of the formulation through a global evaluation by the participants and the investigators.
- Conditions
- Acne Vulgaris
- Being tested
- Rehmannia glutinosa leaf extract, Microcrystalline Cellulose (MCC)
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehmannia glutinosa leaf extractOther
One capsule to be taken after breakfast.
Microcrystalline Cellulose (MCC)Other
One capsule to be taken after breakfast.
| Study group | Role | What they receive |
|---|---|---|
| Rehmannia glutinosa leaf extract | Active comparator | One capsule to be taken after breakfast for 56 days Receives: Other: Rehmannia glutinosa leaf extract |
| Microcrystalline Cellulose (MCC) | Placebo comparator | One capsule to be taken after breakfast for 56 days Receives: Other: Microcrystalline Cellulose (MCC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acne severity: The global acne grading system
Acne lesions will be counted separately for all the six locations. Then the acne score (S) will be multiplied with the area factor (F) to get local score of that particular area. All six local scores will be summed to get the total scores. The total acne severity scores will be obtained on day 0, day 28, and day 56. The change in acne severity of all the enrolled participants will be assessed after 28 and 56 days of supplementation from baseline (Day 0) and in comparison to placebo.
Measured: Day 0 Day 28 and Day 56
Secondary outcomes (10)
Count of inflammatory acne lesions
Acne vulgaris involves complications of pilosebaceous unit that causes inflammatory lesions (papules, pustules, and nodules).
Inflammatory acne lesions are manifested by typical signs of inflammation i.e., swelling, redness, pain and heat.
All the inflammatory acne lesions on the face will be counted on day 0, 28 and day 56.
Any change in the number of these lesions on day 28 and 56 will be compared with baseline and placebo.
Measured: Day 0 Day 28 and Day 56
Sebum secretion
Change in the facial sebum secretion will be assessed by Sebumeter® SM 815. decreased value interprets betterment of acne from Day 0 to Day 28 and Day 56 in comparison to Investigational product with placebo
Measured: Day 0 Day 28 and Day 56
Acne Quality of life questionnaire
Acne-QoL consist of 19 items stratified in four subscales; Self-perception, Role-emotional, Role-social, and Acne symptoms.
The QoL of such participants will be assessed using Acne-Specific Quality of Life Questionnaire (Acne-QoL) questionnaire.
The total score varies from 0 to 114, distributed as follows: 0- 30 (self-perception), 0-24 (role-social), 0- 30 (role-emotional), and 0-30 (acne symptoms). A higher score reflects better health related QoL .
Measured: Day 0 Day 28 and Day 56
Percentage responders
The participants' acne severity will be assessed using GAGS on day 0, 28 and 56. Participants will be declared as responders based on the improvement in acne severity as per GAGS severity grading system (based on total scores). Participants with improvement in acne severity by one grade or more as per GAGS on day 28 and 56 in comparison to baseline (Day 0) will be considered as responders. Percentage population of these responders will be evaluated in comparison to placebo
Measured: Day 0 Day 28 and Day 56
Pain VAS
A VAS is an scale that measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is used regularly in clinical research studies for measuring the intensity or frequency of various symptoms. In the present study, a similar VAS will be used for assessment of physical symptoms associated with inflammatory acne lesions i.e., pain. The participant will be asked to mark the their severity of lesion pain as per the last 7 days on a 0 - 100 mm VAS scale on day 0, 28 and 56, where 0 - is no pain at all and 100 - is unbearable pain
Measured: Day 0 Day 28 and Day 56
Modified Fitzpatrick Wrinkle Severity Scale
Changes in the wrinkle class from Class 3.0 indicated worst means Deep wrinkle. Deep and furrow wrinkle; more than 3-mm wrinkle depth to Class 0 indicates Good means No wrinkle. No visible wrinkle; continuous skin line.
Measured: Day 0 Day 28 and Day 56
Skin parameters using a participant based self-assessment questionnaire
Highest Score represents Better and lowest Score represents Worst
Measured: Day 0 Day 28 and Day 56
Global evaluation of the efficacy by investigator
The investigator will assess on a scale of 0 (Very poor) to 4 (Excellent) as to how beneficial or vice-versa was the treatment experience over the study period on day 56. The outcomes will be evaluated in comparison to placebo
Measured: Day 56
Itch VAS
A VAS is an scale that measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is used regularly in clinical research studies for measuring the intensity or frequency of various symptoms. In the present study, a similar VAS will be used for assessment of physical symptoms associated with inflammatory acne lesions i.e., Itch. The participant will be asked to mark the their severity of lesion itch as per the last 7 days on a 0 - 100 mm VAS scale on day 0, 28 and 56 where 0 - is no itch at all and 100 - is unbearable itch.
Measured: Day 0 Day 28 and Day 56
Global evaluation of the tolerability by Participant
The Participant will self-assess on a scale of 0 (Very poor) to 4 (Excellent) as to how beneficial or vice-versa was the treatment experience over the study period on day 56. The outcomes will be evaluated in comparison to placebo
Measured: Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start5 Jun 2021
- Primary completion9 Aug 2021
- Study completion4 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Arm 1: Rehmannia Glutinosa leaf extract Arm 2: Placebo
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Manjiri Jagtap, M.B.B.S, D.N.B, Principal investigator, SKIN CURE N CARE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04937374
- Sponsor's protocol ID
- NS/201101/REHGLU/AV
- Status last verified
- Oct 2021
- First submitted
- 31 May 2021
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerability of Rehmannia Glutinosa Leaf Extract in the Treatment of Acne Vulgaris: a Double Blinded, Randomized, Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04937374
- Acronym / sponsor ID
- NS/201101/REHGLU/AV
- Conditions
- Acne Vulgaris
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Jun 2021 (actual)
- Primary completion
- 9 Aug 2021 (actual)
- Study completion
- 4 Oct 2021 (actual)
- First posted
- 24 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, The Investigator will be assessing the efficacy and tolerability of Rehmannia glutinosa Libosch leaf-based extract formulation consumption on the treatment of Acne Vulgaris in a randomized, double-blind, placebo-controlled study for the duration of 56 days.
Detailed description
In this study, The Investigator will be assessing the efficacy and tolerability of Rehmannia glutinosa Libosch leaf-based extract formulation consumption on the treatment of Acne Vulgaris in a randomized, double-blind, placebo-controlled study. The participants will consume one capsule per day containing active ingredient for the duration of 56 days. Throughout the duration of the clinical trial, The Investigator will be studying the formulation's effects on the change in the Global Acne Grading System (GAGS) score, facial sebum secretion, the number and irritability of inflammatory lesions, quality of life via the Acne-QoL questionnaire, skin wrinkle severity through the Modified Fitzpatrick Wrinkle Severity Scale (MFWS) and the percentage population of responders at the end of the study. The Investigator will also assess the change in skin radiance, luminosity, smoothness, texture, firmness, and skin hydration through a participant based self-assessment questionnaire as well as the safety and tolerability of the formulation through a global evaluation by the participants and the investigators.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Arm 1: Rehmannia Glutinosa leaf extract Arm 2: Placebo
| Arm | Type | Receives |
|---|---|---|
| Rehmannia glutinosa leaf extract | Active comparator | Other: Rehmannia glutinosa leaf extractOne capsule to be taken after breakfast for 56 days |
| Microcrystalline Cellulose (MCC) | Placebo comparator | Other: Microcrystalline Cellulose (MCC)One capsule to be taken after breakfast for 56 days |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Females aged 18 to 35 years
- Body Mass Index (BMI) in the range of ≥ 18.5 to ≤ 29.9 kg/m2.
- Moderate to severe acne as per GAGS (defined with a score of 19 to 38)
- Participants ready to continue usual skin care regime till the entirety of study duration.
- Participant willing to abstain Anti-acne preparations (creams, face wash, home remedies, etc) throughout the study.
Key exclusion criteria (24 listed)
- Unwilling to forgo any aesthetic or dermatological treatments or procedures during the study period.
- Consumption of any over-the-counter or prescribed oral anti-acne medications during the last 3 months prior to screening
- Currently applying any over-the-counter or prescribed anti-acne medication including, but not limited to, retinoic acid or benzoyl peroxide over the past 3 months prior to screening.
- Participants who have used facial, topical or injectable steroids 6 weeks prior to screening and during the study.
- Females suffering from Polycystic Ovary Syndrome (PCOS).
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 |
|---|---|---|
| Rehmannia glutinosa leaf extractOne capsule to be taken after breakfast. | Other | Rehmannia glutinosa leaf extract |
| Microcrystalline Cellulose (MCC)One capsule to be taken after breakfast. | Other | Microcrystalline Cellulose (MCC) |
Primary outcome
Acne severity: The global acne grading system
Time frame: Day 0 Day 28 and Day 56
Acne lesions will be counted separately for all the six locations. Then the acne score (S) will be multiplied with the area factor (F) to get local score of that particular area. All six local scores will be summed to get the total scores. The total acne severity scores will be obtained on day 0, day 28, and day 56. The change in acne severity of all the enrolled participants will be assessed after 28 and 56 days of supplementation from baseline (Day 0) and in comparison to placebo.
10 secondary outcomes
Count of inflammatory acne lesions
Time frame: Day 0 Day 28 and Day 56
Sebum secretion
Time frame: Day 0 Day 28 and Day 56
Acne Quality of life questionnaire
Time frame: Day 0 Day 28 and Day 56
Percentage responders
Time frame: Day 0 Day 28 and Day 56
Pain VAS
Time frame: Day 0 Day 28 and Day 56
Modified Fitzpatrick Wrinkle Severity Scale
Time frame: Day 0 Day 28 and Day 56
Skin parameters using a participant based self-assessment questionnaire
Time frame: Day 0 Day 28 and Day 56
Global evaluation of the efficacy by investigator
Time frame: Day 56
Itch VAS
Time frame: Day 0 Day 28 and Day 56
Global evaluation of the tolerability by Participant
Time frame: Day 56
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
Related trials for Acne Vulgaris
Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
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.
Dr. Manjiri Jagtap, M.B.B.S, D.N.B principal investigator
SKIN CURE N CARE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehmannia glutinosa leaf extract and Microcrystalline Cellulose (MCC) in people with Acne Vulgaris, run by Vedic Lifesciences Pvt. Ltd. at 1 site in India.
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 8 inclusion and 24 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 Oct 2021. 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 India. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Acne severity: The global acne grading system (time frame: Day 0 Day 28 and Day 56). 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 Oct 2021.