To study the effect of a test product versus a marketed product on skin in humans

A monocentric, double blinded, single group, non-randomized comparative study to evaluate in use tolerance of a test product versus marketed product in healthy participants. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/04/065730

Enrollment

Registered

2024-04-16

Start date

Unknown

Completion date

Unknown

Last updated

2025-05-26

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

Conditions

None listed

Interventions

Intervention1: A-Ret Improvised- Tretinoin 0.1% (Test product): Approximately 0.03 g of the test product and control product will be applied on test and control sites, respectively so as to cover mark

Eligibility

Inclusion criteria

Inclusion criteria: 1. Voluntary men and /or women >= 18 years of age. 2. 50 % Dry skin type (MoistureMeter SC Readings < 20) and 50% normal skin type. 3. Having signed a Consent Form after the study has been explained orally and in writing, of all information concerning the study procedures and study objectives. 4. Presenting healthy skin on test sites. 5. Cooperating informed of the need and duration of the examinations.

Exclusion criteria

Exclusion criteria: 1. Pregnant women by UPT, Lactating mothers. 2. Allergic to any cosmetic product. 3. A participant who the Investigator feels will not be compliant with study requirements. 4. Any type of skin disorder which Investigator feels will interfere with the study 5. Participants on any medical treatment either systemic or topical which may interfere with the performance of the study treatment (presently or in the past 1 month). E.g. topical steroids. 6. Chronic illness which may influence the skin sensitivity (skin problems like atopic dermatitis, psoriasis, eczema or diseases like hypothyroidism, anaemia, hormonal problems, or patients on anti-cholesterol drugs, etc) 7. Any cutaneous disease which would predispose to dry skin (confirmed by prior history). 8. Any cutaneous conditions on test site (scars, moles, papules etc). 9. Subject in an exclusion period or already participating in another similar cosmetic or therapeutic trial as identified during screening on visit 1 (V1).

Design outcomes

Primary

Measure	Time frame
1. Hydration measurements 2. TEWL measurementsTimepoint: 0 hour, 1 hour, 6 hour, 15 days, 30 days	—

Secondary

Measure	Time frame
1. Clinical evaluation for tolerance 2. Overall tolerance on 10 point VAS 3. Tolerance questionnaireTimepoint: 1 hour, 6 hour, 15 days, 30 days	—

Countries

India

Contacts

Public ContactMrs P Meena

Clinical Aesthetics and Investigative Management Service Pvt. Ltd. (C.L.A.I.M.S.PVT.LTD.)

meena@claimsclinical.com66758851

Outcome results