Trial Condition(s):
Skin recovery
A study to gain information how well dexpanthenol dermal spray helps the skin to recover after a peeling in the external genital area of women
Bayer Identifier:
20507
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 after a dermatological procedure (peeling) in the intimate area of women.
After the peeling, 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 and II according to the Fitzpatrick scale;
- Participants willing to have peeling in the genital area to improve the general appearance of the skin and bleaching of spots.Exclusion Criteria
- Pathologies and/or skin injuries, such as psoriasis, sensitive skin, skin cancer, atopic dermatitis or other medical criteria to be considered at the time of evaluation
- Hyperpigmentation in the test area that interfere with the evaluation of possible reactions (vascular malformations, scars, increase of pilosity and large amount of nevi)
- Pathologies and/or active skin injuries (local and/or disseminated) in the evaluation areaTrial 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
Safety Assessment, Instrumental and Perceived Efficacy 21 days of use at home – Bepantol Derma Spray® Dermal and Gynecological Acceptability Assessment.
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
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 12 to 60 (a higher score represents higher efficacy).Timeframe: Up to 23 days
- Treatment satisfactionParticipants assess their treatment satisfaction with a questionnaire consisting of 19 items (each item is scored from 1-5) resulting in a score range of 19 to 95 (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 gynecological evaluationTimeframe: Up to 23 days
- Severity of adverse events by dermatological evaluationTimeframe: Up to 23 days
- Severity of adverse events by gynecological evaluationTimeframe: Up to 23 days
Additional Information
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