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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.

A single blinded, parallel treatment 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.

Status
Recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/10/004038
Enrollment
70
Registered
2013-10-01
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Zandu Lalima: Observation: Baseline, week 5, week 8, week 10. Direction: take 2 teaspoonfuls of Zandu Lalima, twice daily after meals for 8 weeks. Assessments: Dermatologist, Instrumen

Sponsors

EMAMI LIMITED
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
a) The purpose of this study is to evaluate the efficacy of Zandu Lalima in acne vulgaris (pimples) & Skin Fairness. 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. 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

MeasureTime frame
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.

Countries

India

Contacts

Public ContactMs Yamini Patil

KETs Scientific Research Centre

yamini@kelkarcosmetology.com02225639644

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026