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A study to assess the comedogenic potential of Test Product in Healthy Human Participants.

A clinical study to assess the comedogenic potential (ability to form microcomedons) of a test product after 28 days of continuous application on whole face of healthy human participants. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/03/082611
Enrollment
36
Registered
2025-03-18
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

None listed

Interventions

Intervention1: Alverise Bio Instant & Intensive Moisturizing Lotion: Approx. 0.3-0.5 gm will be applied on whole face. They will be asked to apply product once a day during daytime. Control Interventi

Sponsors

Encore Healthcare Pvt. Ltd.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Healthy adult males and non-pregnant/non-lactating females between age group of 18 and 35 years (both inclusive) at the time of consent) 2. Female participants of childbearing potential must have a negative urine pregnancy test performed on screening visit. 3. Participants who are in good general health as determined by the Investigator on the basis of medical history. 4. Participants who are willing to use provided test product throughout the study period as instructed.

Exclusion criteria

Exclusion criteria: 1. Female participants who are pregnant or breastfeeding or planning pregnancy during the study period. 2. Participants with active acne vulgaris on the face. 3. Participants with drug induced acne as disclosed by them. 4. Participants with any pigmentary disorder including freckles and melasma. 5. Participants with damaged skin in or around application sites, excessive hair, moles, open wounds, cuts, abrasions, irritation symptoms, scars, sunburn or any dermatological condition on the test site(s) that can interfere with the reading.

Design outcomes

Primary

MeasureTime frame
Dermatological AssessmentsTimepoint: Day 01 to Day 14 (plus 02 days) and Day 28 (plus 02 days).

Secondary

MeasureTime frame
Participant Satisfaction QuestionnaireTimepoint: Day 14 (plus 02 days) and Day 28 (plus 02 days)

Countries

India

Contacts

Public ContactDr Parth Joshi

Cliantha Research

ssethi@cliantha.com9825784942

Outcome results

None listed

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