An Efficiency of a Moisturizer Containing Licochalcone A, L-carnitine and 1,2-decanediol With Adapalene Gel in Acne

• Sponsor: Mahidol University
• Information provided by (Responsible Party): Mahidol University

Tracking Information

• First Submitted Date: June 18, 2014
• First Posted Date: June 24, 2014
• Results First Submitted Date: July 29, 2015
• Results First Posted Date: February 26, 2016
• Last Update Posted Date: January 23, 2017
• Study Start Date: July 2014
• Actual Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 29, 2016)

• Reduction of Undesirable Effects [ Time Frame: 2nd week, 4th week, and 8th week ]
  • Undesirable effects were evaluated from skin's condition/signs(erythema, dryness and scaling) are evaluated by dermatologist. (none; mild; moderate; severe) and subject interview/symptoms(stinging/burning and pruritis) are evaluated by participants.(none; mild; moderate; severe). There were assessed at 2nd week, 4th week, and 8th week.
  • The worst score of each parameter which was defined as the worst local tolerance score is demonstrated and compared among 3 groups as shown.
• Skin Tolerability: Skin Sebum Content and Skin Hydration [ Time Frame: Skin tolerability was assessed at baseline and week 8. The changes of skin tolerability between baseline and 8th week of the 3 groups were compared. ]
  Skin tolerability was assessed by measuring the skin surface sebum content, skin hydration with the Sebumeter SM815 and Corneometer CM825, respectively
• Skin Tolerability: Transepidermal Water Loss (TEWL) [ Time Frame: Skin tolerability was assessed at baseline and week 8. The changes of skin tolerability between baseline and 8th week of the 3 groups were compared. ]
  Skin tolerability was assessed by measuring TEWL with the Tewameter TM300

Original Primary Outcome Measures (submitted: June 23, 2014)

Reduction of Undesirable Effects [ Time Frame: 2nd week, 4th week and 8th week ]

• Skin's condition/signs(erythema, dryness and scaling) are evaluated by dermatologist. (0-none; 1-mild; 2-moderate; 3-severe)
• Subject interview/symptoms(stinging/burning and pruritis) are evaluated by participants.(0-none; 1-mild; 2-moderate; 3-severe)

• Change History: Complete list of historical versions of study NCT02173054 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: January 29, 2016)

• Reduction of Severity of Acne [ Time Frame: baseline, 2nd week, 4th week and 8th week ]
  • Evaluation from mean counts of inflammatory, noninflammatory, and total acne lesions at baseline, and at 2, 4, and 8 weeks
  • Total acne lesions = inflammatory + noninflammatory acne lesions
  • Reduction of lesions counts are considered to be a better outcome
• Reduction of Severity of Acne: Acne Severity Index (ASI) [ Time Frame: baseline, 2nd week, 4th week and 8th week ]
  • The ASI score was calculated from the number of papules + (2 x pustules) + (comedones/4)
  • Decrease of ASI score are considered to be a better outcome

Original Secondary Outcome Measures (submitted: June 23, 2014)

Reduction of severity of acne and oily facial skin [ Time Frame: baseline, 2nd week, 4th week and 8th week ]

• Evaluation using Investigators' Global Assessment scale of FDA (Food and Drug Administration) for severity of acne
• Measurement of bioengineering property of skin using Sebumeter®, Corneometer®, Tewameter®

• Current Other Pre-specified Outcome Measures: Not Provided

Original Other Pre-specified Outcome Measures (submitted: June 23, 2014)

Evaluation of quality of life and satisfaction [ Time Frame: 8 week ]

• Dermatology Life Quality Index(DLQI) at baseline and 8th week
• Rating of patient satisfaction (0=most unsatisfied to 10=most satisfied) at 2nd week, 4th week and 8th week.

Descriptive Information

• Brief Title: An Efficiency of a Moisturizer Containing Licochalcone A, L-carnitine and 1,2-decanediol With Adapalene Gel in Acne
• Official Title: An Evaluator-blind, Randomized, Vehicle-controlled Efficiency of Adjunctive Usage of a Moisturizer Containing Licochalcone A, L-carnitine and 1,2-decanediol With Adapalene Gel for Improvement of Local Tolerance in Thai Acne Subjects

Brief Summary

Acne is an inflammation of sebaceous glands and follicles. Applying topical treatments such as adapalene gel may cause irritant adverse effects. Hence, using a moisturizer is another way to protect or relieve this undesirable event. Moisturizers that have anti-inflammatory property could reduce irritant effects, emergent from using topical treatment and also reduce severity of acne.

Research teams chose an adapalene gel to act as topical treatment for curing acne. It has anti-inflammatory and comedolytic effects and has fewer side effects than other groups of topical retinoic acids. However, peeling skin, redness skin, tingling sensation or itching sensation may occur if they are continually used for a long period. Thus, for the purpose of studying the efficacy of moisturizer containing licochalcone A, L-carnitine and 1,2-decanediol in reducing irritant effect of using adapalene gel (Licochalcone A has anti-inflammatory effect, L-carnitine decrease sebum production and 1,2-decanediol has anti-bacterial effect).

• Detailed Description: The investigators team research with patients by separate patients into 3 groups and compare among each other. In the first group use only adapalene gel, the second group use adapalene gel with moisturizer containing three substances mentioned above, and the last group use adapalene gel with placebo moisturizer. To compare outcomes among 3 groups, the investigators will measure degree of redness, scale, oily face, moist, number of acne, quality of life, and satisfaction after using moisturizer.
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Acne

Intervention

• Other: Adapalene gel with Eucerin
  Eucerin: 2 fingertip unit to cover all over the face twice a day. Adapalene gel: 2 fingertip unit to cover all over the face before going to bed
  Other Names:

  • licochalcone A + L-carnitine + decanediol (Eucerin)
  • Adapalene gel (Differin)
• Other: Adapalene gel
  Adapalene gel: 2 fingertip unit to cover all over the face before going to bed
  Other Name: Adapalene gel (Differin)
• Other: Adapalene gel with placebo moisturizer
  Placebo: 2 fingertip unit to cover all over the face twice a day. Adapalene gel: 2 fingertip unit to cover all over the face before going to bed
  Other Name: •Adapalene gel (Differin)

Study Arms

• Placebo Comparator: Adapalene gel

  Evening

  • Wash face by prepared facial foam and dry your face
  • Apply adapalene gel all over the face
  Intervention: Other: Adapalene gel
• Placebo Comparator: Adapalene gel with placebo moisturizer

  Morning

  • Wash face by prepared facial foam and dry their face
  • Apply placebo cream all over the face

  Evening

  • Wash face by prepared facial foam and dry your face
  • Apply adapalene gel all over the face
  • Apply placebo cream all over the face
  Intervention: Other: Adapalene gel with placebo moisturizer
• Active Comparator: Adapalene gel with Eucerin

  Morning

  • Wash face by prepared facial foam and dry their face
  • Apply Eucerin cream all over the face

  Evening

  • Wash face by prepared facial foam and dry your face
  • Apply adapalene gel all over the face
  • Apply Eucerin cream all over the face
  Intervention: Other: Adapalene gel with Eucerin

• Publications *: Chularojanamontri L, Tuchinda P, Kulthanan K, Varothai S, Winayanuwattikun W. A double-blinded, randomized, vehicle-controlled study to access skin tolerability and efficacy of an anti-inflammatory moisturizer in treatment of acne with 0.1% adapalene gel. J Dermatolog Treat. 2016;27(2):140-5. doi: 10.3109/09546634.2015.1079298. Epub 2015 Sep 2.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 23, 2014): 120
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: July 2015
• Actual Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Age 18 years old or above
2. Participants have to control the birth for example, condom method, intrauterine device method before participate in the research at least 1 month until 6 months after research finish.
3. being diagnosed acne vulgaris by dermatologist in mild to moderate degree based on Investigators' Global Assessment scale of FDA

Exclusion Criteria:

1. Use oral or injected antibiotics or other oral medicine treating acne for example, isotretinoin, oral contraceptives, or spironolactone group during 4 weeks before participate this research
2. Have other active skin diseases at face during 2 weeks before participate the research
3. Allergic to adapalene gel and moisturizer
4. Have severe or uncontrolled underlying diseases
5. Getting pregnant or during breast feeding
6. Other types of acne(not acne vulgaris)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Thailand

Administrative Information

• NCT Number: NCT02173054
• Other Study ID Numbers: Acne and adjuctive moisturizer
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Mahidol University
• Study Sponsor: Mahidol University
• Collaborators: Not Provided

Investigators

• Principal Investigator: Papapit Tuchinda, MD; Mahidol University

• PRS Account: Mahidol University
• Verification Date: November 2016