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This study checks if Demelan Face Wash could clog pores and cause breakouts. Using a "follicular biopsy" test, researchers examine small skin samples to see if the face wash blocks hair follicles. This helps ensure its safe for acne-prone skin.

Evaluation of comedogenicity potential of the Demelan Face Wash by follicular biopsy test - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/11/077105
Enrollment
24
Registered
2024-11-20
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

None listed

Interventions

Control Intervention1: nil: nil

Sponsors

Sami - Sabinsa group ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Healthy male and female volunteers aged 18 to 65 with no active dermatological conditions 2. Good general and mental health with, in the opinion of the investigator or medically qualified designee with no clinically significant and relevant abnormalities in medical history or upon physical examination 3. Subjects who have normal, dry, oily, combination (mixed) type of skin types. 5. Fitzpatrick photo type I to VI skin type. 6. Willingness to participate as evidenced by voluntary written informed consent.

Exclusion criteria

Exclusion criteria: Subjects presenting and/or satisfying any of the following criteria will not be included in this study: 1. Women who are known to be pregnant or who are intending to become pregnant over the duration of the study 2. Women who are breast-feeding 3. Any history of significant dermatological diseases or conditions or medical conditions known to alter skin appearance or physiologic response (e.g. diabetes,) which could, in the opinion of the Investigator, preclude topical application of the investigational products and/or interfere with the evaluation of the test site reaction. 4. Presence of Acne, TLC more than 10 (Inflammatory & Non-Inflammatory). 5. Active dermatosis (local or disseminated) might interfere with the results of the study. 6. Considered immune compromised. 7. History of photosensitivity, & or diseases aggravated or triggered by ultraviolet radiation. 8. Participants with dermatographism. 9. Currently using any medication which in the opinion of the investigator, may affect the evaluation of the study product, or place the subject at undue risk. 10. Use of the following topical or systemic medications: immunosuppressants, antihistamines, nonhormonal anti-inflammatory drugs, and corticosteroids up to 2 weeks before screening visit. 11. Oral or topical treatment with vitamin A acid and/or its derivatives up to 1 month before the screening visit 12. Intention of being vaccinated during the study period or vaccination within 3 weeks of the screening visit. 13. Currently receiving allergy injections, or due to receive an injection within 7 days prior to Visit1, or expects to begin injections during study participation 14. Previous history of atopic dermatitis, allergic reactions, irritation or intense discomfort feelings to topical use products, cosmetics, or medication 15. Known or suspected intolerance or hypersensitivity to any of the study materials (or closely related compounds) or any of their stated ingredients including any component of the study product. 16. History of sensitization in a previous study. 17 Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30days of the screening visit 18. Recent history (within the last years) of alcohol or other substance abuse

Design outcomes

Primary

MeasureTime frame
To determine the comedogenic potential of the Demelan Face Wash when applied topically under occlusive conditions on the skin of human subjects.Timepoint: Study duration is 28 Days. Follow-up every 3rd day till the end of the study.

Secondary

MeasureTime frame
To determine the comedogenic potential of the Demelan Face Wash when applied topically under occlusive conditions on the skin of human subjects.Timepoint: final outcome will measured at day 28.

Countries

India

Contacts

Public ContactSatish

Sami-sabina group ltd

satish.g@sami-sabinagroup.com9900128263

Outcome results

None listed

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