Trial Condition(s):
Erythema, Skin recovery
A study to gain information how well dexpanthenol derma cream helps the face skin to recover after cosmetic lasering
Bayer Identifier:
20577
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 cream on skin recovery and reduction of skin rash after a dermatological procedure (ablative laser) on the face for treatment of fine wrinkles, scars and open pores in adult women.
After the dermatological procedure, participants will return within 3 weeks for 4 visits to the study center to investigate the skin conditions such as redness, irritation, softness and possible side effects. In addition, study participants will be asked about their general acceptance of dexpanthenol cream.
Inclusion Criteria
- Phototypes I or II according to the Fitzpatrick scale
- Participants willing to perform the dermatological procedure (ablative laser) on the face for treatment of fine wrinkles, scars and open pores, rosacea
- Normal eye examinationExclusion 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 and cutaneous marks 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
- People with entropy, ectropion, stye, conjunctivitis, uveitis or other active eye diseases
- People with corneal ulcerations, blepharitis, meibomitis, pterygium, trichiasis, distichiasis or other eye diseases of moderate or serious intensityTrial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Medcin Instituto da Pele Sao Paulo, Brazil, 06023-070 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
Evaluation of the Safety and Efficacy of the product Bepantol® Cream after the dermatological procedure in the face.
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
N/A
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Skin barrier integrity 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)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 8 to 55 (a higher score represents higher efficacy).Timeframe: Up to 23 days
- Treatment satisfactionParticipants assess their treatment satisfaction with a questionnaire consisting of 23 items (each item is scored from 1-5) resulting in a score range of 23 to 115 (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 7 items (each item is scored from 1-5) resulting in a score range from 7 to 35 (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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