Trial Condition(s):
Erythema, Skin recovery
A study to gain information how well dexpanthenol dermal spray helps the face skin to recover after cosmetic lasering
Bayer Identifier:
20505
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
In this study, researchers want to learn more about the effect of dexpanthenol dermal spray on skin recovery and reduction of skin redness after a dermatological procedure (non-ablative laser) on the face for treatment of fine wrinkles, scars, open pores and change of pigmentation.
After the dermatological procedure, participants will return within 3 weeks for 4 visits to the study center to investigate the skin conditions such redness, irritation, softness and possible side effects. In addition, study participants will be asked about their general acceptance of dexpanthenol dermal spray.
Inclusion Criteria
- Phototypes I or II according to the Fitzpatrick scale - Participants willing to perform the dermatological procedure (non-ablative laser) on the face for treatment of fine wrinkles, scars and open pores, rosacea, poikiloderma, and melasma - Normal eye examination
Exclusion Criteria
- Cutaneous pathologies and/or injuries as psoriasis, sensible skin, cancer of the skin, rosacea, atopic dermatitis or other medical criteria to be considered at the moment of the evaluation; - Hyperpigmentation in the test area that intervenes with the evaluation of possible reactions - Active cutaneous pathologies and/or injuries (local and/or disseminated) in the evaluation area - Aesthetic or dermatological treatment in the area of evaluation up to 04 weeks before the selection
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Medcin Instituto da Pele Sao Paulo, Brazil, 06023-070 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
Evaluation of the Safety and Efficacy of the product Bepantol® Derma Spray after the dermatological procedure in the face - 21 days of follow-up.
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
N/A
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Transepidermal water loss by TEWL probeThe transepidermal water loss (TEWL) is measured in g m2 h-1 with a Tewameter TM300.Timeframe: Up to 23 days
- Dermic temperature by thermographic camera (FLIR T530sc)Timeframe: Up to 23 days
Secondary Outcome
- Skin properties of the participantsInvestigators assess various skin properties of the participants with a questionnaire (each scored from 1 to 5), resulting in an overall efficacy score from 9 to 45 (a higher score represents higher efficacy).Timeframe: Up to 23 days
- Treatment satisfactionParticipants assess their treatment satisfaction with a questionnaire consisting of 13 items (each item is scored from 1-5) resulting in a score range of 13 to 65 (a higher score represents better treatment satisfaction).Timeframe: Up to 23 days
- Product evaluationParticipants assess their sensorial perception of different product attributes (e.g. smell, absorption) with a questionnaire consisting of 6 items (each item is scored from 1-5) resulting in a score range from 6 to 30 (a higher score represents higher product satisfaction).Timeframe: Up to 23 days
- Number of adverse events by dermatological evaluationTimeframe: Up to 23 days
- Number of adverse events by ophthalmologic valuationTimeframe: Up to 23 days
- Severity of adverse events by dermatological evaluationTimeframe: Up to 23 days
- Severity of adverse events by ophthalmologic valuationTimeframe: Up to 23 days
Additional Information
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