Clinical safety and efficacy study of test products in mild to moderate acne patients.
- Conditions
- Health Condition 1: L700- Acne vulgaris
- Registration Number
- CTRI/2024/08/071879
- Lead Sponsor
- Cipla Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1)Age: 16 to 35 years (both inclusive) old at the time of consent.
2) Sex: Healthy adult males and non-pregnant/non-lactating females. (Preferably equal number
of males and females will be enrolled in the study)
3) Females of childbearing potential have a self-reported negative urine pregnancy test at the
time of the screening visit and agree to follow an accepted method of birth control for the
duration of the study such as condoms, foams, jellies, diaphragm, intrauterine device etc.
4) Patients are generally in good general health as determined from recent medical history.
5) Patients with acne of mild to moderate severity as per the IGA scale.
6) Patients who commit not to use medicated skincare products (OTC products, cosmetic comedogenic products, moisturizing products, anti-acne and anti-seborrhoeic products) other
than the test product for the entire duration of the study.
7) Patients is able to remain on stable doses of contraceptive or replacement hormonal therapy,
including no therapy, 6 weeks prior to and for the duration of the study.
8) If the Patients is of childbearing potential, is practicing and agrees to maintain an established
method of birth control (IUD, hormonal implant device/injection, regular use of birth control
pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or
foam, partner vasectomy or abstinence). Females will be considered as non-childbearing
potential if they are surgically sterile, have been post-menopausal for at least 1 year or have
had a tubal ligation.
9) Patients are willing to give written informed consent and are willing to come for regular follow
up.
10) Patients who have not participated in a similar investigation in the past three months.
11) Willing to use test product throughout the study period.
1)History of any dermatological condition of the skin disease.
2) Subject with present condition of allergic response to any cosmetic product.
3) Subjects under chronic medication (e.g. aspirin-based products, anti-inflammatories, anti histamines, corticosteroid therapy etc.) that might influence the outcome of the study.
4) Subject having acne of severe incidence (presence of nodules, cysts) which requires
pharmaceutical product.
5) Subjects had performed any acne treatment throughout the study.
6) Subjects who have applied topical product for at least 4 weeks and any systemic product for
at least 3 months, adjuvant product/therapy before they participated in the study.
7) History of alcohol or drug addiction
8) Subjects using other marketed anti-acne products during the study period.
9) Any other condition which could warrant exclusion from the study, as per the
dermatologist’s/investigator’s discretion.
10) Pregnant or breastfeeding or planning to become pregnant during the study period.
11) History of chronic illness which may influence the cutaneous state.
12) Subjects participating in other similar cosmetics, devices or therapeutic trials or skincare
products within the last four weeks.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the effectiveness of the test products in terms of <br/ ><br>1. change in sebum level. <br/ ><br>2. change in acne severity by investigator global assessment scale. (IGA Scale)Timepoint: Before usage of the test products on Day 01 and after usage of test products at T20 mins on Day 01, Day 07, Day 28
- Secondary Outcome Measures
Name Time Method