Clinical trial NCT04937374: Efficacy and Tolerability of Rehmannia Glutinosa Leaf Extract in the Treatment of Acne Vulgaris
Official title: Efficacy and Tolerability of Rehmannia Glutinosa Leaf Extract in the Treatment of Acne Vulgaris: a Double Blinded, Randomized, Placebo-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acne Vulgaris
Lead sponsor: Vedic Lifesciences Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2021-06-24
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Arm 1: Rehmannia Glutinosa leaf extract

Arm 2: Placebo
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Females aged 18 to 35 years
2. Body Mass Index (BMI) in the range of ≥ 18.5 to ≤ 29.9 kg/m2.
3. Moderate to severe acne as per GAGS (defined with a score of 19 to 38)
4. Participants ready to continue usual skin care regime till the entirety of study duration.
5. Participant willing to abstain Anti-acne preparations (creams, face wash, home remedies, etc) throughout the study.
6. 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.
7. Participants must be willing to complete all study designated questionnaires and diaries or any other related procedures or requirements.
8. Participants having the ability to understand and sign a written informed consent form.

Exclusion Criteria:

1. Unwilling to forgo any aesthetic or dermatological treatments or procedures during the study period.
2. Consumption of any over-the-counter or prescribed oral anti-acne medications during the last 3 months prior to screening
3. 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.
4. Participants who have used facial, topical or injectable steroids 6 weeks prior to screening and during the study.
5. Females suffering from Polycystic Ovary Syndrome (PCOS).
6. Participant using oil and oil-based preparations for skin.
7. 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.
8. History of Hormonal imbalance
9. Abnormal Thyroid Stimulating Hormone (TSH) value which is \< 0.35 or \> 4.94 µIU/mL.
10. Participant with high caffeine consumption, (defined as \>3 cups of coffee consumption in a day).
11. Topical or systemic use of antifungals and antibiotics in the previous 2 weeks prior to screening.
12. Participant having extremely oily food habits.
13. Participants taking drugs known to be photosensitizers including, but not limited to, phenothiazines, amiodarone, quinine, thiazides, tetracyclines, sulphonamides, quinolones
14. Known sensitivity to the investigational product or any excipients of the drug product.
15. Smoking or using any tobacco products.
16. Having a history of chronic skin allergies.
17. History of any significant neurological and psychiatric condition which may affect the participation and inference of the study's end points.
18. Participation in other clinical trials in last 30 days prior to screening
19. 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.
20. 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.)
21. Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives.
22. 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.

Primary outcomes:
measure: Acne severity: The global acne grading system
timeFrame: Day 0 Day 28 and Day 56
Secondary outcomes:
measure: Count of inflammatory acne lesions
timeFrame: Day 0 Day 28 and Day 56
measure: Sebum secretion
timeFrame: Day 0 Day 28 and Day 56
measure: Acne Quality of life questionnaire
timeFrame: Day 0 Day 28 and Day 56
measure: Percentage responders
timeFrame: Day 0 Day 28 and Day 56
measure: Pain VAS
timeFrame: Day 0 Day 28 and Day 56
measure: Modified Fitzpatrick Wrinkle Severity Scale
timeFrame: Day 0 Day 28 and Day 56
measure: Skin parameters using a participant based self-assessment questionnaire
timeFrame: Day 0 Day 28 and Day 56
measure: Global evaluation of the efficacy by investigator
timeFrame: Day 56
measure: Itch VAS
timeFrame: Day 0 Day 28 and Day 56
measure: Global evaluation of the tolerability by Participant
timeFrame: Day 56
Other outcomes:
Locations:
city: Thane
country: India
facility: Skin cure and care clinic
state: Maharashtra
Study officials:
affiliation: SKIN CURE N CARE
name: Dr. Manjiri Jagtap, M.B.B.S, D.N.B
role: PRINCIPAL_INVESTIGATOR
References: