Efficacy and Tolerability of Rehmannia Glutinosa Leaf Extract in the Treatment of Acne Vulgaris

NCT04937374 | Completed

• 1 other identifier: NS/201101/REHGLU/AV
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 0 Day 28 and Day 56

Secondary Outcomes (10)

• Count of inflammatory acne lesions

  Day 0 Day 28 and Day 56

• Sebum secretion

  Day 0 Day 28 and Day 56

• Acne Quality of life questionnaire

  Day 0 Day 28 and Day 56

• Percentage responders

  Day 0 Day 28 and Day 56

• Pain VAS

  Day 0 Day 28 and Day 56

Study Arms (2)

Rehmannia glutinosa leaf extract

ACTIVE COMPARATOR

One capsule to be taken after breakfast for 56 days

Other: Rehmannia glutinosa leaf extract

Microcrystalline Cellulose (MCC)

PLACEBO COMPARATOR

One capsule to be taken after breakfast for 56 days

Other: Microcrystalline Cellulose (MCC)

Interventions

Rehmannia glutinosa leaf extract OTHER

One capsule to be taken after breakfast.

Rehmannia glutinosa leaf extract

Microcrystalline Cellulose (MCC) OTHER

One capsule to be taken after breakfast.

Microcrystalline Cellulose (MCC)

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Vedic Lifesciences Pvt. Ltd.: lead

Study Sites (1)

Skin cure and care clinic

Thane, Maharashtra, 400602, India

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

microcrystalline cellulose

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• Dr. Manjiri Jagtap, M.B.B.S, D.N.B

  SKIN CURE N CARE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Arm 1: Rehmannia Glutinosa leaf extract Arm 2: Placebo

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: June 24, 2021
• Study Start: June 5, 2021
• Primary Completion: August 9, 2021
• Study Completion: October 4, 2021
• Last Updated: October 19, 2021

Record last verified: 2021-10

Locations

IN (1)