Trial Condition(s):
Skin recovery
A study to gain information how well dexpanthenol dermal spray helps the skin to recover after laser hair removal in the groin and intimate area
Bayer Identifier:
20506
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 for hair removal (laser depilation) in the groin and intimate area in adult women.
After the hair removal procedure, participants will return within 3 weeks for 3 visits to the study center to investigate the skin condition such as redness, irritation, softness of skin and possible side effects. Study participants will also 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 a dermatological procedure (laser depilation) in the inguinal region to remove hairs in the regionExclusion 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
- Hyperpigmentations 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 and Efficacy Evaluation of the use of Bepantol® Derma Spray after laser depilation in the inguinal region in adult women - 21 Days Use at Home
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 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
- Severity of adverse events by dermatological evaluationTimeframe: Up to 23 days
Additional Information
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