To study the Effectiveness and Safety of GUGGULCERA in the Treatment of Mild to Severe Acne Vulgaris and overall skin health

Not yet recruiting

Conditions: Other specified local infections of the skin and subcutaneous tissue,

Registration Number: CTRI/2021/10/037244

Lead Sponsor: Vidya Herbs Pvt Ltd

Brief Summary: Acne vulgaris is a disorder of thepilosebaceous gland occurring usually at puberty but can also be seen in adultage.[1] The disease characterized by theformation of open and closed comedones (non-inflammatory lesions), papules,pustules, and nodulocystic lesions (inflammatory lesions). The diseasegenerally affects the face, arms, and back. The multifactorial pathogenesis ofacne vulgaris includes follicular hyperkeratinization, abnormal sebumproduction, bacterial proliferation, and inflammation.[2] Acnevulgaris has been divided into four grades â€“ 1, 2, 3, and 4. Grade 1 consistsof comedones and occasional papules. Grade 2 consists of papules, comedones andfew pustules. Grade 3 consists of predominant pustules, nodules, and abscesses.Grade 4 consists of mainly cysts, abscesses, and widespread scarring.[3] The aims of treatment are to controlinflammation, decrease the activity of the sebaceous glands, normalizefollicular proliferation, and decrease bacterial colonization. Drugs used forGrades 1 and 2 (mild-to-moderate case) of acne vulgaris are topicalcomedolytics, antibacterial, and retinoids as monotherapy or combinationtherapy. Grades 3 and 4 (severe cases) of acne vulgaris require systemic antibacterialalong with topical agents.[4]

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

Male or female aged 18 â€“ 40 years of age both inclusive in general good health Must have a definite clinical diagnosis of mild to severe acne vulgaris Grade 2 Grade 3 or Grade 4 on the Investigators Global Assessment IGA of acne severity 1 Must be willing and able to give informed consent and comply with the study procedures Female patients of childbearing potential must have been using accepted methods of birth control or must agree to continue to practice abstinence from 30 days prior to study entry to 30 days after the last administration of study drug.

Exclusion Criteria

1.Known conditions that may interfere with the evaluation of acne vulgaris.
Such conditions include but are not limited to the following: rosacea; seborrheic dermatitis; perioral dermatitis; corticosteroid-induced acne or folliculitis; carcinoid syndrome; squamous cell carcinoma; mastocytosis; acneiform eruptions caused by make-up or medication; bacterial folliculitis; facial psoriasis; and facial eczema.
2.Subjects allergic to herbal products or any component of the study product 3.Subjects who have been treated topical or oral corticosteroids within 14 days prior to baseline 4.History of uncontrolled disease or immune deficient disorder 5.Any feature in the test areas (face) that according to the investigator may influence the results, for example, but not limited to moles, tattoos, scars, irritated skin, scratches, cuts and excess hair 6.Known HIV or Hepatitis B positive or any other immuno-compromised state 7.Female subjects who are pregnant, nursing or planning to become pregnant during study participation 8.Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study 9.Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assess the Effectiveness and Safety of GUGGULCERA in the Treatment of Mild to Severe Acne Vulgaris and overall skin health	Proportion of subjects in each treatment group achieving success at Week 12, with success defined as IGA score of clear or almost clear and at least a one-point reduction in IGA score compared to Baseline. \| Mean percentage change in total acne, inflammatory and non-inflammatory lesion count from baseline to end of the study

Secondary Outcome Measures

Name	Time	Method
To assess the effect of the treatment arm in comparison with placebo on the â€œThe Cardiff acne disability indexâ€	To assess the safety and tolerability of the test product.

Trial Locations

Locations (1): Skin Xperts Unit of BGMF SkinXperts Pvt Ltd
🇮🇳
Bangalore, KARNATAKA, India
Skin Xperts Unit of BGMF SkinXperts Pvt Ltd
🇮🇳Bangalore, KARNATAKA, India
Dr Sunil Kumar Prabhu
Principal investigator
9900102030
sunilpr13@gmail.com