clinical study; to evaluate the efficacy and safety of Zandu Lalima Vs Topical Cream in treatment of Acne Vulgaris (pimples) and improvement in skin lightness on healthy human subjects.

Phase 3

Registration Number: CTRI/2013/10/004038

Lead Sponsor: EMAMI LIMITED

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 70

Inclusion Criteria

1.Volunteer in generally good health.

2.Volunteer between the ages of 18 to 25 years.

3.Volunteer suffering from mild to moderate symptoms of acne vulgaris (pimples).

4.Volunteer having regular menstrual cycles of approximately 25 to 35 days.

5.Volunteer willing to do blood test as per study requirement.

6.Volunteer willing for still photography.

7.Volunteer has not participated in a similar clinical investigation in the past four weeks.

8.Volunteer without known allergy/ sensitivity to cosmetic products or fragrance and without any skin allergies / infections.

9.Volunteer not under any dermatologic treatment / prescribed medications.

10.Volunteer willing to abstain from using any cosmetic product on face, besides the provided product during the entire study course.

11.Volunteer willing to visit the site at specified frequencies for periodic evaluations.

12.Volunteer willing to comply with study specific requirements.

13.Volunteer willing to give a written informed consent and come for regular observation.

Exclusion Criteria

1.A known history or present condition of allergic response to any cosmetic products.

2.Skin disease except acne vulgaris (pimples) (e.g. psoriasis, atopic dermatitis or other cutaneous manifestations on the scalp), which would interfere with the test readings.

3.Medications (e.g. steroids or antihistamines), which would compromise the study.

4. Currently or has been undergoing dermatologist facial treatments or procedures within the last 1 month.

5.Subject viewed by the investigator as not being able to complete the study or participating in another study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
a)The purpose of this study is to evaluate the efficacy of Zandu Lalima in acne vulgaris (pimples) & Skin Fairness. <br/ ><br>b)To evaluate the efficacy of test drug Zandu Lalima in comparison to standard therapeutic Topical Cream available at present in term of Mild to Moderate acne vulgaris (pimples) &Skin Fairness. <br/ ><br>c)Safety of the test drug in above protocol by evaluating through questionnaire / clinical measurement & other biochemical parameters.Timepoint: This will be a 10 weeks study. All the subjects will be assessed on Baseline, week 5, week 8 and week 10.

Secondary Outcome Measures

Name	Time	Method
To evaluate the compliance of the therapy in respect of available drugs and also the quality of life.Timepoint: This will be a 10 weeks study. All the subjects will be assessed on Baseline, week 5, week 8 and week 10.