Application of Shalmali Gel on face with oral intake of Khadiratriphaladi Kwatha Ghana capsule in management of Acne vulgaris

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Adolescents aged between 10-16 years of either gender having classical features of Yuvanpidika.

2.Adolescent has an Investigator’s Global Assessment (IGA) score of 2-3 [0 (clear) to 4 (severe) scale]. (Mild to moderate cases of facial Acne vulgaris)

3.Adolescents/ Parents willing to give written informed assent/ consent.

4.Adolescents and parent/guardian (if applicable) are willing to comply with study instructions and return to the OPD for required visits.

Exclusion Criteria

1.Adolescents having any other skin pathology or condition that could interfere with the evaluation of the test products or requires the use of interfering topical or systemic therapy.

2.Adolescents having nodulocystic acne.

3.Adolescents having any systemic diseases and auto immune disorder.

4.Adolescents currently enrolled in an investigational drug or device study.

5.Adolescents who have received an investigational drug or has been treated with an investigational device within 30 days prior to the initiation of treatment (Baseline).

6.Adolescents having known hypersensitivity or previous allergic reaction to any of the active or inactive components of the test articles

7.Adolescents and parent/guardian (if applicable) are unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function.

8.Adolescent has used any of the following topical anti-acne preparations or procedures on the face:

a.Topical anti-acne treatments including, but not limited to, over-the-counter (OTC) acne cleansers or treatments, benzoyl peroxide, antibiotics, azelaic acid, sulfa based products, corticosteroids and salicylic acid within two (2) weeks of the initiation of treatment.

b.Retinoids, including tazarotene, adapalene, tretinoin, within four (4) weeks of the initiation of treatment.

c.Light treatments, microdermabrasion, or chemical peels within eight (8) weeks of the initiation of treatment.

9.Adolescent has used the following systemic anti-acne medications:

a.Corticosteroids (including intramuscular and intralesional injections) within four (4) weeks of the initiation of treatment. Inhaled, intranasal or ocular corticosteroids are allowed if use is stable (stable use is defined as dose and frequency unchanged for at least four (4) weeks prior to the initiation of treatment).

b.Antibiotics within four (4) weeks of the initiation of treatment with the exception of five (5) days or less of antibiotic therapy during this period, BUT with no antibiotics use permitted within one (1) week prior to the initiation of treatment.

c.Spironolactone within eight (8) weeks of the initiation of treatment with the exception of five (5) days or less of spironolactone therapy during this period, BUT with no spironolactone use permitted within one (1) week prior to the initiation of treatment.

d.Retinoid therapy within six (6) months of the initiation of treatment

e.Other systemic therapy which may materially affect the subject’s acne in the opinion of the investigator.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in the IGA scoreTimepoint: 4 weeks, 8 weeks,12 weeks

Secondary Outcome Measures

Name	Time	Method
<br/ ><br>1.Reduction in clinical features of Yuvanpidika as per classical texts of Ayurveda. <br/ ><br>2.Improvement in CDLQI <br/ ><br>3.Reduction in Lesion counts as evidenced by photographs.Timepoint: 4 weeks, 8 weeks,12 weeks