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Evaluation of the safety of 1 test product for phototoxicity, using a photo patch test technique

Evaluation of the safety of 1 test product for phototoxicity, using a photo patch test technique

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2011/06/001778
Enrollment
24
Registered
2011-06-03
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: Moisturizing Complex : The Product is a Moisturizing Complex which is a white semisolid preparation in a cosmetic cream base. It consists following actives CococinTM 0.5

Sponsors

AMRA Remedies
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Voluntary men and/or women. 2. Between 18 and 65 years. 3. Photo type III and IV. 4. Having apparently healthy skin on test area. 5. Willingness to discontinue the use of cleansing and/or cosmetic products in the treatment areas during the course of the study. 6. For whom the investigator considers that the compliance will be correct. 7. Cooperating, informed of the need and duration of the examinations, and ready to comply with protocol procedures. 8. Having signed a Consent Form and will be once informed orally and in writing of all information concerning the study procedures and study objectives. 9. Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the course of the study except as required for study protocol. 10. Willingness to avoid water contact (i.e.: swimming) or activity which cause sweating (i.e.: exercise, sauna?), during the course of the study. 11. Ready to wear loose cotton clothes.

Exclusion criteria

Exclusion criteria: 1. People who have a job involving water contact or a job which causes perspiration. (Routine work can be done. No carrying out activities like excessive/brisk walking, exercising etc). 2. Pregnant women and lactating women. Scars, excessive terminal hair or tattoo on the studied area. 3. Dermatological infection/pathology on the level of studied area. 4. Hypersensitivity, allergy antecedent (to any cosmetic product, raw material, UV light or sunlight). 5. Any clinically significant systemic or cutaneous disease, which may interfere with study treatments or procedures. 6. Subjects 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). 7. 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

MeasureTime frame
To evaluate the cutaneous tolerance by dermatological scoring of skin reactions using Draize scale.Timepoint: 48 hours

Secondary

MeasureTime frame
NoneTimepoint: None

Countries

India

Contacts

Public ContactMrs Tulip Bhattacharjee
rsjdr@rediffmail.com66758851

Outcome results

None listed

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